Promoting Good Governance For Non-Prescription Medicines

Final - adopted by Steering Group 17/4/2013
REPORT OF THE WORKING GROUP ON PROMOTING GOOD GOVERNANCE OF NON-PRESCRIPTION DRUGS IN EUROPE 1
June 2013
The present document is without prejudice to any existing or future EU/ national and international legislation.
Table of contents
1. 2. 3. 4. 5. 6. 7. 8. 9. Overview and Context..........................................................................................................3 Background ..........................................................................................................................4 The Landscape......................................................................................................................6 Methods and approaches of the Project Group ..................................................................13 Findings from review of evidence......................................................................................16 Success factors, barriers and enablers to access to non-prescription medicines ................25 Conclusions ........................................................................................................................32 Recommendations ..............................................................................................................38 Looking ahead ....................................................................................................................41
References .................................................................................................................................42 Glossary .....................................................................................................................................45 Annex 1......................................................................................................................................48 Annex 2......................................................................................................................................54 Annex 3 Group Members .......................................................................................................59 Annex 4......................................................................................................................................60 Annex 5 - National initiatives to widen access to non-prescription medicines.........................73 Annex 6 - National Best Practice examples...........................................................................83
1.
Overview and Context
1.1 The healthcare environment is changing across the EU. With an ageing population and economic constraints on healthcare systems there is an increased focus on how to make best use of healthcare resources. Self-care has a role to play in encouraging people to take more responsibility for their own health and wellbeing; making healthy life choices; consulting their doctor and or pharmacists where appropriate; and knowing if and when medical treatment should be sought. 1.2 Patient behaviour is also changing across Member States, particularly with regard to growing empowerment in self-care, new routes of access to medicines, and crossborder patient movement. As part of self-care, self-medication enables people to treat or prevent short term or chronic illnesses when they consider they do not need to consult a doctor, or which they may treat after an initial medical diagnosis. Research [Ref 1] reveals the positive effects of patient empowerment and selfmanagement, and as healthcare moves closer to the patient, self-care has the potential to play an increasingly greater role in public health. 1.3 Over the years the practice of treating ailments with non-prescription medicines has developed as the importance of self-care within healthcare systems has become recognised, and the process of reclassifying medicines from prescription only to nonprescription has progressed in some Member States to allow a wider range of treatments to be made available for self-medication [Ref 2]. 1.4 Patient safety is a prime consideration in all aspects of self-care, including in the regulation of non-prescription medicines within the EU. Robust evidence is required to demonstrate that a medicine can be used safely and appropriately without medical supervision before it can be classified as non-prescription, and ongoing monitoring of safety in use is required. 1.5 The range of non-prescription medicines is evolving as more treatments are becoming available for conditions that have traditionally been self-managed and as medicines are reclassified to non-prescription with new self-medication indications. 1.6 Recognising that legal status remains primarily a national competency there is considerable variability in availability of non-prescription medicines within the EU. Good governance of non-prescription medicines goes beyond the regulatory process and is part of corporate social responsibility in a wider sense. People should be able to look after themselves, and need the tools and support to do this. Governments,
regulators, health professionals, patient and consumer representatives, and nonprescription medicines manufacturers all have a responsibility to ensure the correct measures are in place to facilitate the availability and uptake of non-prescription medicines, and their safe and responsible choice and use. 1.7 The Project Group on Promoting Good Governance of Non-prescription Medicines in the EU was one of the initiatives of the Platform on Access to Medicines in Europe - a work area of the Process on Corporate Responsibility in the Field of Pharmaceuticals. The Process was dedicated to enhancing collaboration among Member States and all interested relevant stakeholders in order to find common, nonregulatory approaches to timely and equitable access to medicines. The objective of the Project was to identify the necessary elements to ensure availability, uptake, and informed use and choice of non-prescription medicines. 1.8 The Project was undertaken within a changing European legal environment in light of the implementation of the revised Pharmacovigilance legislation, implementation of the Falsified Medicines Directive and plans for new legislation in relation to patient information. Furthermore, it was recognised that the regulatory environment for authorisation of medicinal products is changing in relation to use of the centralised, mutual recognition and decentralised procedures. 1.9 The Project investigated in particular the role of competent authorities, pharmaceutical companies, consumers and patients, and health professionals in facilitating uptake and proper use of non-prescription medicines. All these stakeholders were represented on the Project Group. 1.10 This Project Group offered a chance for all stakeholders to come together and identify measures needed to ensure that EU citizens have access to non-prescription medicines and are fully supported to practise safe, effective and appropriate self-care.
2.
Background
2.1 The European pharmaceutical sector is confronted today with many challenges. Due to the importance of medicinal products for the protection of public health, it is necessary to ensure that all partners exercise their responsibilities in accordance with public health and societal needs. The Terms of Reference and the composition of the Process on Corporate Responsibility in the Field of Pharmaceuticals are provided in Annex 1 to this report.
2.2 The rationale for the Process on Corporate Responsibility in the Field of Pharmaceuticals was not to be confined to one objective. There was an effort to pursue multifold objectives i.e. to: I. improve access to medicines across the EU; II. discuss issues relating to the long term viability of the EU based pharmaceutical industry, and III. enhance the role that patients can play in determining and addressing their medical needs. 2.3 Due to the wide scope of the topics the following three independent platforms were launched under the Process: Platform on Access to Medicines in Europe Platform on Ethics and Transparency Platform on Access to Medicines in the developing countries with a focus on Africa.
2.4 Under the Platform on Access to Medicines in Europe the following project groups were put in place in order to give the participating stakeholders the opportunity to exchange ideas and knowledge, as well as to explore non-regulatory conditions that may impact on access to medicines after their marketing authorisation: Mechanisms of coordinated access to orphan medicinal products Capacity building on managed entry agreements for innovative medicines Facilitating supply in small markets Market access for biosimilars Prioritisation of medicines
And Promoting good governance for non-prescription medicines
2.5 Since the organisation and delivery of healthcare and the classification of medicines are both primarily national competencies, the extent to which self-care is
practised and encouraged, and the range of medicines available without prescription, as well as the circumstances under which they can be accessed, varies widely across the EU. Some countries have well developed self-care systems and policies, enabling access to a wide range of non-prescription medicines for acute and chronic conditions and for ill health prevention, as well as models of care within national health systems to encourage and empower people to self-manage their conditions under the supervision of a health professional. Other countries have a more restricted range of non-prescription medicines and self-care is limited to the treatment of minor self-limiting conditions. However, the situation is dynamic and, increasingly, national governments are looking at how self-care and self-medication can better contribute to healthcare. 2.6 The Project Group on "Promoting good governance for non-prescription medicines" sought to gain a better understanding of the different approaches and attitudes to availability and use of non-prescription medicines across the EU. The Group sought to identify the key factors that contribute to good access to nonprescription medicines in order to explore common, non-regulatory approaches to timely access to non-prescription medicines irrespective of national decisions on classification, and to provide a source of information for governments who wish to take national action to widen access to non-prescription medicines while maintaining safeguards to public health. The Terms of Reference for the Project Group are set out in Annex 2.
3.
The Landscape
The role of non-prescription medicines in self-care

3.1. Access to non-prescription medicines allows people to take a more active role in the management of their own health and in the treatment of common illnesses. These medicines give people the responsibility for caring for themselves until or unless a healthcare providers expertise is necessary, and equips them with the power to make a decision about their healthcare and to choose medicines that meet their needs and conditions. When people can treat common ailments themselves, it saves them time and effort and can avoid a visit to the physician. Where appropriate, non-prescription medicines can also help individuals to self-treat embarrassing conditions that they are not willing to discuss with their doctor (see also 3.3).
3.2 While acknowledging that no medicine is risk-free, people believe fundamentally that non-prescription medicines are safe and that they do not usually have serious
side effects: the relative safety is seen as being proportional to the ease of access. Responsibility for safety is seen to be jointly held by the pharmaceutical industry and government. When individuals have a poor understanding of the nature of nonprescription medicines and how to use them, there are risks of incorrect use, misuse or over consumption.
Patient empowerment
3.3 People want to have a more active role in their own healthcare, including in the decisions about what medicines to take. When it comes to access to self-medication, good information and support translate into empowered patients who can benefit fully from the opportunities of self-care and who can practise it safely and effectively with informed choice. As people take on greater responsibility for their healthcare, the need grows to become better informed. It is important for people to have access to high quality information from multiple sources and that information is provided in a variety of formats to meet the needs of different patient groups. 3.4 Information on non-prescription medicines comes from a wide range of sources, starting with a clear and understandable label and package leaflet, and including product websites and advertisements. People are confronted with a growing volume of information that is increasingly personalised and interactive, and need to be able to make sense of this in relation to their particular need and condition. Additionally, advertising messages should be communicated in a way that makes it clear that the message is an advertisement and the product concerned is identified as a medicine. 3.5 Health professionals are an important source of objective and balanced advice about medicines and their uses. Patients understanding of the need to seek professional advice when necessary before buying a non-prescription medicine is part of health literacy and patient empowerment. 3.6 When considering wider access to non-prescription medicines it is important to take into account the needs of people of varying health education and literacy, to ensure that they can read and understand the label and leaflet, and use the medication correctly. At the same time, decisions on wider access should take into account the habits and needs of patients who will take a medicine in accordance with the instructions and seek advice where necessary from a health professional. 3.7 With regard to some non-prescription medicines, certain population groups including teenagers and people with drug addiction are particularly vulnerable. Some medicines, such as painkillers can be abused in intentional overdose while there is a risk of laxative abuse by people with eating disorders. There is a risk of addiction to
medicines containing codeine if they are not taken correctly. These risks need to be managed when considering widening access to non-prescription medicines. 3.8 Misuse of non-prescription medicines can also pose risks to the health of elderly people who are the largest consumers of medicines and are often on multiple medicines. They are more vulnerable to adverse effects and to the risks of multiple or inappropriate medications. They may start using different non-prescription medicines at the same time as their prescribed medicines without informing their doctor; this can cause adverse reactions that can remain undetected. Elderly people should be encouraged to discuss with their pharmacist or doctor before using different nonprescription medicines at the same time as their prescribed medicines.
The important role played by health professionals

3.9 Within healthcare today there are increasing demands on doctors time with an ageing population requiring care for an increasing number of chronic conditions and ongoing economic restraints on healthcare resources. Although responsible self-care helps to ensure that best possible use is made of a doctors time, it is essential that people who choose to self-medicate are able to recognise when their condition may be the sign of a more serious underlying disease, indicating that a diagnosis and medical treatment are needed. Care should be taken to ensure that access to nonprescription medicines does not lead to inappropriate self-medication and that nonprescription medicines are used appropriately so that patients do not delay in seeking advice from a doctor if they have a serious condition. Doctors play a key role in supporting their patients in self-care and in ensuring informed use and proper choice of non-prescription medicines by the patient. In particular, they can reassure patients if they are worried about a minor condition on which they are seeking advice and educate their patients by explaining in certain circumstances, why they could have purchased a medicine in a pharmacy. 3.10 The role of the pharmacist has evolved in healthcare systems. Pharmacists expert knowledge of medicines is well recognised and a broad range of pharmacy services and more complex interventions in relation to medicines use and public health are available from pharmacies across the EU. 3.11 Supporting self-care is recognised by pharmacists in all Member States as being a core activity of the profession [Ref 3]. Widely distributed in Europe and easily accessible pharmacists are often the first and sometimes the only health professional to assist a patient in their self-care journey, in: advising on the management of symptoms;
providing advice on maintaining good health and avoiding illness, and; selecting the most appropriate medication.
3.12 Pharmacists also have an important role to play in encouraging people to read the label and patient leaflet and in reinforcing the information to ensure safe and effective use of non-prescription medicines, particularly when there is a risk of incorrect use or abuse. This is especially important with newly reclassified medicines. 3.13 In addition, pharmacists play an important role in signposting patients by referring them to the doctor or another appropriate health service when medical examination or prescription treatment is considered necessary.
Variability of access
3.14 Non-prescription status is the natural classification for a medicine according to EU legislation. The range of non-prescription medicines available can include not only medicines to treat acute short term self-limiting conditions, but also medicines for chronic disease management and disease prevention. 3.15 However, there is great diversity in the number and type of medicines that are available without prescription across the EU. Specifically, according to a survey based on primary data collected by the Association of the European Self-Medication Industry (AESGP), as of January 2011 there were only 5 molecules (see section 7) that are available in some form without prescription in 24 European countries, and 10 molecules that are available without prescription in 22 European countries (mainly EU Member States) [Ref 4]. Variability between Member States is related not only to the number of non-prescription medicines available, but also to the range of ailments for which non-prescription medicines can be accessed.
Diversity of approaches
3.16 While there is a common medicines regulatory framework in the EU, there is a diversity of approaches between Member States to controlling access to nonprescription medicines, including different national decisions on the classification of medicines. In some countries, non-prescription status is determined on a product by product basis, in others it is substance based. There are also different approaches to the limits for conditions of use for a non-prescription medicine so even if a substance is available without prescription in a number of Member States, there may be differences in relation to, for example, the indications, treatment population, dose, strength, contraindications, and available pack sizes of medicines.
3.17 Member States also have different national policies on distribution of nonprescription medicines, ranging from restricted availability from pharmacies only, to wider access in supermarkets and other outlets, as well as via the internet with or without the supervision of a pharmacist [Ref 5]. 3.18 There are also different approaches to reimbursement and pricing [Ref 6]. In some Member States, reclassification to non-prescription will result in a product no longer being reimbursed by national health insurance systems. Pricing policies also differ between countries, with free pricing on non-prescription medicines being in place in some countries, particularly if medicines are not reimbursed.
Industry and innovation The non-prescription medicines market

3.19 Half of all medicines sold in the EU have a non-prescription status and over 100,000 non-prescription medicines are estimated to be produced and marketed by multi-national as well as many small and medium enterprises. The market in the EU in 2011 was estimated to be in the area of 27 billion Euro, or approximately 15% of the total pharmaceutical market [Ref 7]. The share of sales of non-prescription medicines in various European countries differs considerably.
Innovation in the non-prescription medicines market

3.20 People have always used non-prescription medicines to deal with conditions such as headache, upset stomach, hay fever, cold sores, and diarrhoea. Innovation in the self-care market has resulted in people now being in a position to treat these conditions with modern, clinically proven medicines. For example, whereas once the only way to treat excess gastric acid was through use of an antacid, now people can use alginate rafting agents to stop reflux or use H2-antagonists or proton pump inhibitors (PPI) to reduce acid levels. New self-medication products are usually developed initially for supply on the basis of a prescription by a doctor and are subsequently reclassified as non-prescription medicines based on their established safety profile and potential for effective and safe use as such. 3.21. Innovation in self-care does not only concern new ingredients in nonprescription medicines, but also the indications that are considered suitable for selfmanagement. Vaginal thrush, irritable bowel syndrome, high cholesterol, benign prostatic hyperplasia-related urinary symptoms, migraine, eczema and even emergency contraception are now all accepted in certain European markets as conditions for self-management. In an EU-funded research project [Ref 8] the
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AESGP analysed the potential for innovation in the provision of care, examining how individuals can take on a greater role in the management of their health with the introduction of new indications for self-care. Possible self-care indications identified in this project ranged from the treatment of acute and chronic conditions that can be self-diagnosed, to those that would require a doctor consultation and/or health professional advice before they could be self-managed.
The environment in which industry operates - How products reach the market National and European authorisation of non-prescription medicines
3.22 Every non-prescription medicine on the European market has been assessed for safety and efficacy before it reaches the market and is continually monitored for safety while it is marketed [Ref 9]. The same strict regulatory framework is used for both prescription and non-prescription medicines and when prescription medicines are being evaluated for suitability for non- prescription status. This ensures that citizens in Europe have access to safe and effective products of high quality. The change of legal status from prescription to non-prescription (switch) is addressed by Article 74 of Directive 2001/83/EC and explained in the Commission guideline on changing the classification for the supply of a medicinal product for human use (rev. January 2006). 3.23 Most non-prescription medicines have national marketing authorisations issued by national competent health authorities which are valid only in the country in which they were issued. An increasing number of new prescription-only products are authorised centrally by the European Commission to be marketed across the EU. The use of the centralised procedure for the authorisation of non-prescription medicines, however, has so far been limited, with 5 applications and 2 positive opinions to date (pantoprazole for short-term treatment of reflux symptoms in adults and orlistat for weight loss in adults with BMI of 28 or over). Moreover, if an application for a centrally authorised product to be classified as non-prescription through the centralised procedure has been unsuccessful, it is not possible subsequently to submit an application for a national marketing authorisation for an identical product even when all national requirements for the marketing authorisation are met. 3.24 The centralised procedure ensures availability of non-prescription medicines throughout the EU. The Decentralised and Mutual Recognition procedures allow national products to be marketed across a number of European Member States. The use of these procedures for non-prescription medicines has been disproportionately
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low compared with the respective marketing authorization applications for prescription only medicines. 3.25 As science, the practice of medicine and peoples ability to self-treat evolve and grow, industry is interested in increasing European citizens access to self-care with existing products, and by expanding the types of non-prescription therapies. The nonprescription industry aims at providing the same high quality and safe products to the entire EU market. However, different interpretations of the European legislation have led to major differences in the range of non-prescription medicines available in different Member States. Companies operating in Europe through the Association of the European Self-Medication Industry (AESGP) have set out a programme for change to address the barriers to an efficient regulatory environment [Ref 10]. 3.26 Member States across the EU carrying out their own assessments of safety and efficacy are aware of the need to address differences in the way regulations and guidelines are interpreted and applied throughout Europe. Platforms such as the European Medicines Agencys (EMA) Co-ordination Group [Ref 11] and the Coordination Group for the Mutual Recognition and Decentralised procedures (CMDh) [Ref 12] provide forums for regulators to effectively address these differences. 3.27 As the need for consistency and transparency in decision making for all medicines at both EU and national levels has been universally accepted, the EMA has launched a project on benefit-risk assessment to work in this direction [Ref 13]. At the same time, the non-prescription industry is also engaged with regulators and academics in an open dialogue on how to ensure an appropriate benefit-risk assessment to fully take into account the specificities of non-prescription medicines. A proposal for a new benefit-risk model, specially adapted to non-prescription medicines, has been published by independent researchers [Ref 14]. 3.28 This benefit-risk assessment model for non-prescription medicines has at its heart stakeholder engagement and communication. It aims to develop a common approach to the assessment of non-prescription medicines at different stages: when they are first put on the market, when they are evaluated for non-prescription status and when their safety is monitored post-marketing. 3.29 Worldwide, few non-prescription medicines are protected by patents, but governments have recognised the need to provide other incentives to encourage innovation. The EU pharmaceutical legislation (Directive 2001/83/EC) provides for data exclusivity in the case of applications for new indications for well-established substances, when these result from significant pre-clinical or clinical studies having
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been carried out by the applicant [Ref 15]. Similarly, a one-year data exclusivity period can be given in the EU in the case of re-classification of a medicine from prescription only to non-prescription status [Ref 16] if this results from significant preclinical tests or clinical trials carried out by the marketing authorisation holder/applicant.
Pricing
3.30 Whereas Member States usually control the prices of prescription only medicines supplied under national healthcare systems, no price control measures apply for non-reimbursed non-prescription medicines in the majority of EU Member States. The pricing of non-reimbursed medicines was examined by the European Commission and the EU Pharmaceutical Forum in 2007, which concluded that price control is not necessary for non-reimbursed medicines. For these products, price competition can steer the price evolution sufficiently well [Ref 17]. 3.31 The consumer healthcare sector represents a competitive market, with strong competition not only between non-prescription medicines, but also from products of other categories (e.g. medical devices, cosmetics, food supplements). Therefore pricing policy for non-prescription medicines is a determining factor for ensuring the functioning of a competitive market where manufacturers are incentivised to innovate and offer citizens the best value at an acceptable price.
4.
Methods and approaches of the Project Group
4.1 The Project Group worked within agreed Terms of Reference, according to which a detailed work plan was compiled.
Terms of Reference
Scope and Objectives: 1) To assess the situation on the ground in relation to access to non-prescription medicines across Member States 2) To identify examples of how access to non-prescription medicines can support patients to take shared responsibility for their own health care 3) To identify medicines where non-prescription access has the potential to have a significant impact on public health and to consider what may be learnt from experience of successful and unsuccessful reclassifications
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4) To consider the barriers and enablers to the availability, uptake, informed use and choice of non-prescription medicines, including: how the current regulatory system operates in relation to non- prescription medicines statutory Product Information. branding the role of advertising and media communication about non- prescription medicines, and information to support non-prescription medicines. pricing and reimbursement issues
5) To explore health professional and patient attitudes and what may support a proactive and supportive approach to self-care.
Membership of the Group

4.2 The Project Group was co chaired by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Commission. The membership of the Project Group comprised representatives from competent authorities, pharmaceutical companies, consumers and patients, and health professionals. The Commission invited representatives from all Member States to join the Project Group and the invitation was accepted by the Czech Republic, Denmark, Germany, Ireland, Italy, Lithuania, Portugal and the UK. A full list of those who participated in the Project Group is at Annex 3.
Work plan
4.3 The Project Groups work was developed and coordinated through 12 teleconferences and four face-to-face meetings two held in Brussels and one each in Copenhagen and London. The Group agreed a work plan detailing various work streams, and the methodology and actions required to deliver the work areas covered. All members of the Group contributed significantly to the delivery of the work plan. Individual members took the lead on different items, with input and support from the rest of the Group. Considerable work was undertaken by group members in between contact times, collating information and exploring issues based on their experiences and expertise. Face to face meetings were used to share information gathered, exchange views, and discuss and agree on the main recommendations.
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4.4 Work topics included: An analysis of the factors that contribute to successful and unsuccessful availability, uptake and informed use of a medicine after it has been reclassified An historical overview of the development of the non-prescription medicines sector An overview of studies examining the positive economic impact of self-care in EU Member States Analysis of case histories of availability and uptake of non-prescription medicines following reclassification, and of the impact of switches. A review and study of the attitudes and experiences of patients and health professionals to non-prescription medicines and self-care across the EU An analysis of the education and training of health professionals to support self-care and uptake of newly reclassified non-prescription medicines An analysis of rules in Member States for advertising and provision of nonstatutory information A collation of national initiatives within Member States to improve access to non-prescription medicines. Contributions were received from all Member States represented on the Group.
4.5 To support the work of the Group, the European Medicines Information Network (EMINeT) [Ref 18] was commissioned to map (Annex 4) the landscape of nonprescription medicines and reclassification across the EU Member States, focussing on four areas: OTC market shares in the EU Switches of active ingredients in the EU in the last decade Distribution channels for OTC medicines in the EU Pricing and reimbursement regulation for OTC medicines in the EU
4.6 EMINet was also commissioned to undertake a stakeholder survey in European countries in order to identify the barriers and supporting factors for switches, and to
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explore the switch climate in those countries.
5.
Findings from review of evidence
Map of the non-prescription medicines landscape in the EU

5.1 The mapping exercise undertaken by EMINeT [Ref 4,5,6,19] revealed a diversity of systems and approaches to the regulation, and access to market, of nonprescription medicines in Member States. 5.2 The analysis of switches of medicines or substances from prescription only to non-prescription showed that a number of switches have been undertaken in several countries in the last decade, resulting in around 60 active ingredients having obtained non-prescription status in some cases with a more restricted Summary of Product Characteristics (SmPC) in at least one European country out of the 24 countries (mostly EU Member States) surveyed. It was clear that major differences still exist across European countries in relation to switches. 5.3 The analysis of non-prescription markets showed considerable differences between European countries, both in terms of percentage market share of total medicines sales and in the development of those markets. 5.4 Regarding pricing and reimbursement, and distribution it can be seen that there is considerable variation in policy on accessibility of non-prescription medicines through health systems, and the type of outlet where non-prescription medicines can be purchased. Figure 1 provides an overview of the reimbursement regulations for nonprescription medicines. In most European countries reimbursement of nonprescription medicines is, in principle, possible, under certain specific restrictions. But there are some countries where non-prescription medicines are never reimbursed. This has implications for pricing, since in most European countries price control is usually only applicable for medicines which are reimbursed, whereas free pricing is applied to non-reimbursable medicines.
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5.5 The research findings show no high-level correlation between distribution and reimbursement of non-prescription medicines, and the number of active ingredients switched and /or market share of non-prescription medicines. However, there appear to be some geographical patterns. For instance, the Mediterranean countries all have comparably low market shares of non-prescription medicines even though distribution arrangements vary. For example, Greece and Spain have a strongly regulated pharmacy sector, Italy allows the sale of non-prescription medicines from nonpharmacy outlets provided the sale is supervised and a pharmacist is on the premises, and Portugal allows the sale of non-prescription medicines through nonpharmacy outlets without the need for the presence and supervision of a pharmacist. 5.6 From analysis of the non-prescription markets (using 2010 data or latest year available), there appears to be no correlation between the size of the market and the number of substances switched to non-prescription status. For example, Italy, which was shown to have one of the largest numbers of substances reclassified (42), had
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one of the lowest market shares, whereas Czech Republic, which had a similar number of substances switched (37) had one of the largest market shares (32.4%).
Advertising and media communications Advertising Regulatory Models

5.7 It is integral to self-care that manufacturers can communicate with consumers and healthcare providers in a variety of ways to raise awareness of non-prescription medicines in order to explain their purpose and health benefits, the conditions they are intended to treat, and how to use them. 5.8 EU Directive 2001/83/EC allows advertising to the general public of nonprescription medicines in all media subject to certain conditions. In particular, the advertising of products that contain psychotropic or narcotic substances is prohibited, and Member States may prohibit the advertising of non-prescription products that may be reimbursed. Legislation prohibits misleading advertising and requires that advertising should be distinguishable from information. 5.9 An analysis of the rules in Member States for advertising and the provision of nonstatutory information was undertaken in 2011 through a forum of European advertising regulators from 30 countries (all 27 EU Member States, Norway, Iceland and Croatia) which was convened by the UK [Ref 20]. The analysis revealed that there are different advertising regulatory models within Europe with both pre-and post-event controls undertaken by either the state or through self-regulation by the industry. Some Member States have different regulators and/or different regulatory approaches for advertising of non-prescription medicines in TV and radio compared to print, and the requirements for advertising in these media are, in some cases, more restrictive.
On-line networking and social media

5.10 Advertising regulators consider that, since the legislation specifies the content and not the format of advertising, the principles for regulating on-line networking and social media are the same as for other media, however the challenges are different. 5.11 The opportunities presented by these new media are being taken by both advertisers and regulators. Some innovative methods of advertising are emerging, such as sponsored apps on smart phones with pollen counts for hay fever sufferers, and the establishment of Twitter and Facebook accounts by national regulators for speedy and effective dissemination of messages about medicines usage and safety.
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5.12 Specific challenges were identified, for example with use of Facebook, in relation to people posting comments on a site set up by a company. In some Member States, this would not be allowed; in others, companies would need to monitor all postings and take responsibility for the information in them. 5.13 General media activity was seen by advertising regulators as having specific challenges. Coverage of products in the media should be factual and balanced, and not be designed to encourage the unnecessary use of the product. Advertising regulators in some Member States are addressing this issue by developing guidelines for newspapers and medical writers.
Regulators perspectives on advertising of non-prescription medicines

5.14 Regulators participating at a meeting of the forum of EU advertising regulators considered that advertising of non-prescription medicines is provided for in law and companies have a legitimate role in providing information about the existence of their products. Moreover, they recognised that advertising has a role in improving access to non-prescription medicines by raising awareness of the availability of a product without prescription and what it can be used for. 5.15 Self-regulation of advertising of non-prescription medicines is common in the non-prescription medicines sector. Although self-regulatory codes are strongly supported by the regulators, they consider that the legislation needs strict enforcement by competent authorities. 5.16 Regulators considered that self-regulation is particularly effective where there is prior vetting of advertising material and/or competitor review of advertising, with companies in competition monitoring each others activities. However, they considered that monitoring by companies is less effective in relation to gifts and verbal contact with health professionals, since these activities are not generally observed by competitors. Although these activities are more often linked to the prescription only medicines sector, they can exist in the advertising of nonprescription medicines. In the context of the European Commissions Corporate Responsibility initiative in the field of pharmaceuticals, industry and other stakeholders have agreed on a set of Guiding Principles for Ethics and Transparency addressing such concerns. 5.17 Additionally, people need access to authoritative information about nonprescription medicines and their uses, and in this respect competent authorities have a role to play. The EU pharmacovigilance legislation requires product information,
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SmPCs and Patient Leaflets (PLs), to be accessible from competent authorities. Patients and consumers need to be encouraged to use trustworthy sources of information. Regulators participating at the meeting of the Forum of EU advertising regulators considered that the development of the social media (Twitter and Facebook) provides the opportunity for competent authorities to communicate with the public through an increasingly familiar medium, to provide information about public health and medicines, and to warn against incorrect information.
Education and Expectations of stakeholders

5.18 Recognising the importance of education in supporting access to nonprescription medicines, the Project Group undertook an analysis of the education and training of pharmacists and doctors throughout the EU on self-care and access to newly reclassified non-prescription medicines. Consideration was also given to the perspective of patients and consumers, focusing on their educational needs and expectations.
Doctors training
5.19 In its survey of the education and training of doctors in self-care, CPME received responses from 20 countries, 16 of which were EU Member States, and from Serbia, Iceland, Israel, Norway and Switzerland. Three of the countries (Norway, Iceland and Germany) did not respond to the questions since it was considered that in these countries, patients did not consult their doctor for minor ailments. 5.20 The survey revealed that self-care training programmes for doctors were available in only two of the countries that responded. In most countries surveyed, education on self-care for minor ailments is already part of standard undergraduate and specialist training programmes for doctors. However, 9 countries did consider that such training would be of interest and 9 agreed that it would relieve a doctors workload. 5.21 Doctors recognised in particular the importance of patient empowerment through education to ensure that people were able to decide when to seek advice from a doctor when their condition was more serious. However, 12 survey respondents foresaw a risk in this approach unless patient training programmes were designed carefully. They considered that if the programme provided unsafe advice this could lead to delay in medical treatment and aggravation of a patients health condition. Additionally they felt that it might alienate patients who already feel disconnected from doctors and medical advice especially those who would use their minor ailment as an excuse to consult a doctor about a more sensitive or embarrassing problem.
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5.22 The overall conclusion of CPME was that they did not see added value in setting up dedicated self-medication training programmes across all Member States, since this was in many cases covered in doctors basic training.
Pharmacists training
5.23 In a survey of the pre- and post-qualification education and training of pharmacists in self-care and in supporting reclassification of medicines, the PGEU sent a questionnaire to 32 Liaison Secretaries (national representatives) of the European Pharmacy Students Associations (EPSA). 5.24 The key findings of the analysis, based on data from 12 Member States, were that therapeutics and clinical pharmacy are widely implemented in the pharmacy undergraduate course and in this respect there was no distinction between prescription and non-prescription medicines. Subjects such as clinical pharmacy, internal medicine, therapeutics and pharmaceutical care, which form part of the modern pharmacy curriculum, prepare the pharmacy workforce to respond effectively to patients seeking advice on self-medication and self-care. A specific approach to non-prescription medicines as a category within the pharmacy curriculum is unnecessary. 5.25 The pharmacy profession does, however, recognise that communication and patient counselling skills for self-care are different from those required for prescription-led pharmacy services. Communication and counselling skills are not necessarily part of the pharmacists formal education; rather they are expected to be acquired both during the practice period, which is part of formal pharmacy training, and through pharmacy practice once qualified. While most pharmacists acquire these skills in this way, PGEU considered that effective communication and counseling should be an integral part of the pharmacy qualification in all EU Member States. 5.26 In addition, in all EU Member States pharmacists have a professional obligation to remain up-to-date in their practice, which they may do through organised or individual continuing professional development activities. In some Member States continuing education and/or continuing professional development is mandatory. Selfcare issues as well as training in effective communication are a part of these activities. 5.27 The role of meaningful continuing professional development is key, and essential if communication and clinical skills are to be developed in the self-care context. For example, pharmacists are broadly in favour of following systematic approaches (guidelines, standard operating procedures, flow charts, etc) to interactions between
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themselves and patients when supplying non-prescription medicines, as demonstrated in some countries with regard to, for example, emergency hormonal contraception [Ref 21].
Patients/Consumers
5.28 People using non-prescription medicines have different levels of knowledge and understanding of self-medication and they need information and support to help them to make informed decisions about choosing and using self-care products, to help them identify the risks and the benefits associated with non-prescription medicines, and to enable them to engage in self-care to the degree with which they are comfortable. 5.29 A person does not become truly informed just by being presented with information. While some people have the skills to identify authoritative information sources, others may be overwhelmed and unable to distinguish between good and poor information. Doctors and pharmacists have an important role to play in guiding people and helping them to find their way through the information jungle. Health professionals also provide an important service in filtering the information so that it meets the specific needs of an individual. 5.30 Helping and supporting people in self-care demands a significant investment in time from health professionals. Results of mystery shopping exercises conducted during recent years by some consumer organisations in different EU Member States showed that the information which consumers were given by pharmacists when purchasing non-prescription medicines was, in these cases, often inadequate. Patients expect health professionals and in particular pharmacists to be more proactive in providing advice and comparative information on both treatment and nontreatment options, and in the detection of possible interactions with other medicines, herbal preparations, food supplements and foods.
Stakeholders views
5.31 A study was undertaken by EMINET to explore stakeholders views about the switch climate in their country and their attitude to reclassification, non-prescription medicines and self-care. Stakeholders interviewed included in the study were from industry, regulatory authorities, pharmacist associations, consumers and/or patients associations, doctors, researchers and public payers.
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5.32 The study showed that most stakeholders within Member States have a positive attitude to non-prescription medicines and reclassification [Ref 22]. Overall, major benefits attributed to non-prescription medicines by the stakeholders interviewed are: increased accessibility and quicker access to medicines; no waiting times in doctors surgeries; more therapeutic choice, particularly for minor ailments and; freeing up doctors time to allow them to focus on patients with more serious diseases.
5.33 Another benefit identified by some interviewees is savings from public budgets when a medicine is no longer reimbursed after reclassification. This however would mean some detriment for individual patients who have to support the cost of their medicines. 5.34 Regulators, in particular, identify safety as an important criterion in relation to reclassification although this was not the focus for all stakeholders as they trust that authorities will only reclassify a medicine in the case of a positive benefit-risk profile, and patients trust in the advice from pharmacists. 5.35 There are some concerns from stakeholders about patients not being sufficiently informed about non-prescription medicines and self-medication, and possibly not having an appropriate consultation in the pharmacy. 5.36 Of particular concern to industry stakeholders are the costs and considerable efforts invested in reclassification and in supporting introduction into the market of a newly reclassified medicine, particularly considering the time limit of a 12 month data exclusivity period in the EU. 5.37 From analysis of the sales of three reclassified active ingredients (pantoprazole, omeprazole, simvastatin) before and after reclassification [Ref 23] it was found that while total sales of all presentations of the defined active ingredient showed increases, there was no major growth in sales of the product that was actually switched. In general, generic products (usually both prescription and non-prescription) gained market shares in a rather short period after market entry whereas the reclassified originators were commercially unsuccessful. In the case of pantoprazole and simvastatin, growth in prescription sales could be attributed to the reclassification coinciding with patent expiry of the product. Regarding the non-prescription sales,
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these results illustrate the concerns of industry stakeholders and the existence of a commercial risk of some reclassifications for the industry. 5.38 A concern shared by different stakeholder groups in certain countries is the loss of reimbursement after reclassification, which is likely to lead to higher out-of-pocket payments for the patient and/or may cause a shift to more expensive reimbursed medicines prescribed by the doctor. Pharmacists raised concerns about nonprescription medicines being available from non-pharmacy outlets where no counselling would be available from a health professional. 5.39 Stakeholders identified a number of enablers to promote reclassifications, including a supportive regulatory environment, a well-regulated pharmacy system and an environment in which patients are encouraged to take responsibility for their own health, such as the UK Governments policy of encouraging self-care.
National initiatives to widen access to non-prescription medicines

5.40 In response to the need to address the issue of access to non-prescription medicines, a number of Member States have or are undertaking national initiatives to widen access using a variety of approaches. These are detailed in Annex 5. 5.41 The Project Group considered that there was benefit in reviewing such initiatives and the current national legal frameworks for reclassifying a medicine from prescription to non-prescription. This can help to further identify and develop solutions to improving the reclassification environment and generate greater opportunities to increase access to self-care products across the EU.
Best practice in improving access to non-prescription medicines

5.42 As part of its work programme the Project Group identified and discussed a number of areas of best practice that related to improving access to non-prescription medicines. These included initiatives or models of national best practices as well as specific initiatives. Reviewing these examples and the current national legal frameworks for reclassifying a medicine from prescription only to non-prescription can allow further identification of solutions to improve the reclassification environment in order to generate greater opportunities for increasing consumer access to self-care products in the future. These national initiatives are detailed in Annex 6.
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6.
Success factors, barriers and enablers to access to non-prescription medicines
6.1 In considering the necessary elements to ensure availability, uptake, and informed use and choice of non-prescription medicines, and thus achieve a successful reclassification, the work of the Group led to the identification of elements needed for a successful switch and of a number of barriers and enablers regarding access to non-prescription medicines.
Elements of a successful switch

6.2 Non-prescription medicines can empower patients if their availability coincides with their condition, and with what they want, need and understand. For choice in non-prescription medicines to work, the public needs to be engaged, and health professionals need skills and training to deliver impartial advice. Reclassification of a medicine from prescription to non-prescription does not in itself necessarily result in improving access to that medicine. 6.3 In discussing solutions to the barriers and the issue of good governance and access to non-prescription medicines, the Project Group looked beyond the regulatory process and analysed the elements of a successful reclassification (switch). The Group considered what would be the favourable considerations for switch and agreed that these should be based on the characteristics discussed in detail below.
Safety, ease of use and appropriate monitoring for switched products

6.4 Pharmacovigilance evidence to establish an acceptable safety profile for a medicine is pivotal in any reclassification. No products are switched without a full review of their safety and a decision that they can safely be used for self-treatment without medical intervention. Most safety data are gathered from experience of use of a medicine in the prescription setting. While the legislation regarding classification of medicines is common in Europe, opinions on reclassification are often divergent, even with medicines for established self-care indications, the presentation and management of which would, arguably, rarely differ between Member States. 6.5 The move to centralised pharmacovigilance monitoring gives Member States the advantage of easier access to information about the safety in use of medicines that are already available without prescription in other Member States. This pharmacovigilance information could also help to inform Member States decisions on
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reclassification, alongside the considerations of their self-medication culture and the characteristics of their medicines distribution systems. 6.6 Ongoing monitoring of safety of non-prescription medicines in use is important not only for those which are newly reclassified but also for well established products. Appropriate and proportionate action has been taken by the regulators if there is new evidence to demonstrate a change in the safety or risk profile of a non-prescription medicine, including evidence of misuse or abuse. Measures may include: reducing pack size; adding warnings to the label; restricting supply to pharmacies, or; reclassifying to prescription only.
6.7 Many researchers consider that misuse and abuse of non-prescription medicines is not being picked up by the public or health professionals. Research among pharmacists indicates that pharmacists perceive the abuse and misuse of some nonprescription medicines, particularly those containing opioids, antihistamines, and laxatives, to be a problem [Ref 24]. The limited means to control and monitor nonprescription medicine use should be a consideration when a product is reclassified and as part of ongoing safety monitoring.
A clear beneficial impact on public health

6.8 The added value of the non-prescription use of a medicine, both for individuals and for the general population, should support the decision for the switch of a product from prescription only to non-prescription. 6.9 Benefit to public health can be demonstrated in different ways. For example, the development of non-communicable and chronic disease, such as obesity and smoking related diseases, is an emerging public health threat. Empowering people to change behaviours and take steps to prevent the development of chronic disease, such as those related to smoking and obesity, for people who are not yet ill and who are not visiting the doctor, can be supported by access to appropriate nonprescription medicines. Also, patients already suffering from non-communicable and chronic diseases should be better empowered through self-care, with assistance and advice on a regular basis from their doctor and pharmacist where necessary.
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6.10 Self-care is also appropriate for the management of recurring conditions that have already been first diagnosed by a doctor, with on-going health professional support as required.
Responding to the needs and demands of citizens and health professionals, in particular in terms of patient empowerment, timely access, access to improved treatments and improved quality of life
6.11 Efficient, rapid and sustainable symptom relief will enable individuals to carry on with their daily activities. This is particularly significant where quick access to a doctor is not always possible or where delay in treatment can make the condition worse. If symptoms persist, clear warnings on the label and patient leaflet will encourage people to seek advice where there is a need subsequently to consult the doctor. 6.12 Advances in modern medicine, including in pharmacological profile, longer duration of action or fewer side effects, benefit all medicines takers. Where a therapeutic area or indication for self-care is well established and people are accustomed to managing the conditions by themselves, there is benefit in making best use of advances in modern medicine in the range of non-prescription medicines available. 6.13 It is important that health professionals are supported in their decision making when responding to symptoms by evidence-based information and resources in relation to the correct and appropriate use of non-prescription medicines. This is particularly important when a medicine is newly reclassified. 6.14 Post-authorisation studies in the community and primary care setting may be an ideal vehicle for providing ongoing evidence of use of non-prescription medicines in practice and should be encouraged in justified cases.
Fulfilling unmet needs

6.15 For a number of reasons individuals sometimes suffer from conditions without consulting a doctor. This might be because of concern about what might be an unpleasant treatment, because they are embarrassed, because they consider the condition to be too trivial or because they do not think there is a treatment for their problem and they just have to endure it. They may silently suffer from the condition, delaying a visit to the doctor until the situation becomes unbearable; they may also resort to seeking solutions on the internet leaving themselves vulnerable to accessing unproven treatments and counterfeit medicines and risking worsening their conditions.
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6.16 Increasing access to medicines under these circumstances can result in bringing people into the healthcare system sooner and prevent damage to health caused by, for example the use of counterfeit medicines obtained via the internet.
Health professionals embracing the switch

6.17 Support by health professionals is important to ensure effective self-care and self-treatment and as a source of information, support and guidance on self-care. The role of health professionals is also critical to the success of a switched product. 6.18 As people recognise and value the expertise of pharmacists and doctors these health professionals have an important role to play in empowering people to take an active role in their healthcare. The public expects that all the health professionals they encounter are working for the patients best interests and that doctors and pharmacists will collaborate. They expect consistent messages and to be given information that they can understand and act upon. The cooperation of doctors and pharmacists is therefore very important to ensure that patients receive consistent information about the illness, not just the product and its contraindications, as well as information about when it is appropriate to use a non-prescription medicine and when they might need to see a doctor or other health professional. 6.19 Doctors are often unaware that a medicine has been reclassified even in Member States where the self-care culture is well developed. This can inhibit a collaborative approach to supporting patients who move between self-care and the healthcare system.
Barriers to access to non-prescription medicines Focus on risk only without consideration of public health benefit
6.20 The safety of all medicines is a key priority, and assessment of risk in the nonprescription setting is fundamental to reclassification of a medicine. However, there are good examples of the value of improving access to a medicine where it is safe to do so, in terms of public health benefit. 6.21 The benefit-risk model for a non-prescription medicine will vary considerably between different medicinal products. There should be consideration of public health benefit as part of this model for each non-prescription medicine.
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Attitudes and knowledge of stakeholders

6.22 The attitudes of stakeholders to non-prescription medicines can affect access to these medicines in different ways. Lack of patients knowledge about nonprescription medicines can be a barrier to access as it can make people less confident in seeking self-care solutions to looking after themselves. The perception by patients that a medicine which is no longer reimbursed could be ineffective could also be a barrier to accessing non-prescription medicines. 6.23 The attitudes of health professionals are also an important contributor to access to non-prescription medicines since their advice is highly valued by the public. Lack of support from the pharmacist for a new non-prescription medicine can inhibit access to that medicine. Lack of support of non-prescription medicines from doctors can also be a barrier. If opportunities are not taken by doctors to discuss non-prescription options when it is appropriate to do so, and advise on their safe and effective use, people will not be empowered to seek self-care options and access non-prescription medicines.
Differing views between stakeholders

6.24 Different attitudes and inconsistent advice to patients particularly between pharmacists and doctors about self-care can cause confusion and reduce public confidence in self-medication.
Lack of awareness of the product

6.25 If people are not aware of the existence of a product, access can be inhibited especially if a newly reclassified product is for a new indication, not previously covered by the existing range of non-prescription medicines. Advertising plays a role in increasing awareness among all stakeholders of the availability of a medicine without prescription. However, it is important that advertising does not lead to confusion, and that patients and consumers are able to distinguish between advertising and information.
Lack of availability of information for patients

6.26 In addition to information about the products, lack of objective and authoritative information about self-care in general and about illnesses that can be treated with non-prescription medicines can also inhibit access to non-prescription medicines.
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Reimbursement
6.27 The pricing and reimbursement framework for non-prescription medicines differs widely across the EU [Ref 6]. No definite correlation can be found between the range of medicines available without prescription in a country and the extent to which nonprescription medicines are reimbursed. However, national healthcare systems can have an effect on the uptake of non-prescription medicines in different ways. If reclassification would result in a product no longer being reimbursed by national health insurance/systems, for a variety of reasons, the reclassification may not be supported by stakeholders, including manufacturers, doctors, pharmacists and patients. The cost of a prescription fee may also affect uptake if, for example, it was less expensive for a person to visit the doctor and obtain a prescription than purchase the medicine, even though their condition could be safely and effectively treated with a non-prescription medicine. 6.28 A reclassification resulting in a medicine no longer being available through the healthcare system on prescription could result in a mistaken perception by the public that the medicine is no longer as good as a medicine that is available on prescription.
Enablers for a successful Switch

6.29 The Project Group identified the following seven factors as enablers for a successful switch. Awareness of the availability of the product (by all stakeholders)
6.30 Patients who wish to take more responsibility in self-care need to be informed when a medicine, which was previously only available on prescription can be purchased for self-medication, and health professionals need to be aware so that they are in a position to provide advice and support when needed. Safety concerns of all stakeholders are met
6.31 Patient safety is the prime consideration in any decision to make a medicine available as non-prescription. The regulatory systems for reclassification are robust and include a legal requirement for a rigorous safety review. However, some stakeholders, particularly health professionals, may still have safety concerns. A switch will be more successful if all these concerns are addressed and risk is managed and minimised to an acceptable degree.
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All stakeholders have a common approach
6.32 Clear, consistent views and messages about the benefits and risks of a newly reclassified medicine will contribute to a successful switch by increasing patient confidence and ensuring responsible, safe and appropriate use. Patients have access to information and advice
6.33 Patients need not only to be aware of a newly reclassified medicine but also to have access to accurate and impartial information, which can be distinguished from advertising and promotional material, and health professional advice about the product and the therapeutic area for which it is indicated. This gives patients the confidence and the skill to take advantage of availability of the medicine without prescription. Patients are fully empowered by good education and support from health professionals when needed
6.34 Patients who have good basic knowledge and understanding of how to look after themselves are well placed in general to understand where a newly reclassified medicine fits into the area of self-care and will have the confidence to take advantage of its accessibility without the need for a prescription. Education and involvement of pharmacists and doctors
6.35 Education and involvement of pharmacists and doctors is particularly important for innovative switches when a product with a new self-care indication becomes available without prescription, so that patients receive the support they need from doctors and pharmacists to use the product safely and effectively. Meaningful continuing professional education should play a significant role in this process. Economic viability
6.36 Economic viability includes an acceptable commercial return on investment of the switch for the manufacturer and an affordable price for the patient. From the patient perspective, the price of a non-prescription medicine can interfere with the choice to buy the product. When costs of medication become a barrier to its use, the potential to support self-care is diminished. Switches should ideally not lead to health inequalities or penalise people from low income groups.
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7.
Conclusions
A diversity of systems and approaches

7.1 Access to medicines varies considerably across the EU. There is great diversity in the number and types of non-prescription medicines that are available and in how they may be accessed in some Member States they are available only from pharmacies; in others they may be available from non-pharmacy outlets; medicines can also be accessed via the internet. In January 2011 there were only 5 molecules available for certain conditions without prescription in 24 European countries surveyed: paracetamol acetyl salicylic acid pantoprazole orlistat and topical ketoconazole.
7.2 Contributing factors to this diversity include different national decisions on the classification of medicines (not withstanding Member States operate within a common regulatory framework), national policies on distribution of non-prescription medicines, different approaches to reimbursement and pricing, and organisation of healthcare systems, and differing cultural approaches to self-medication. There are also different approaches to enforcement of the regulations related to the advertising and provision of information on non-prescription medicines. 7.3 While recognising that the legal status of a medicine remains a national competency, more could be done to share experiences and views between regulators within the EU and between stakeholders in order to identify common ground.
Barriers, enablers and success factors

7.4 Considering the perspectives of all stakeholders, the group identified barriers and enablers to access to non-prescription medicines as well as factors that would contribute to the successful reclassification of a product from prescription only to nonprescription.
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7.5 Key themes have emerged which are not part of the regulatory process for legal classification and which have helped to identify factors that will contribute to good governance of non-prescription medicines.
Focus on the benefits of medicines

7.6 While the safety of non-prescription medicines must remain a key priority when reclassifying a medicine from prescription only to non-prescription, it is also important that the benefits, as well as the risks of non-prescription medicines are considered. The added value of the use of a medicine without prescription, both for individuals and for public health, should support a decision for the reclassification of a product from prescription only to non-prescription status. An understanding of the benefits as well as the risks by health professionals and patients is also important so that they can make informed choices about recommending and using non-prescription medicines respectively. Examples of switches that have particularly demonstrated public health benefits are nicotine replacement therapy and emergency hormonal contraception.
Safety, ease of use and appropriate monitoring for switched products

7.7 Safety is a priority and a focus for all stakeholders and it is important that the safety concerns of all stakeholders are met. 7.8 The EMA has already recognised the need for the development of tools to ensure a balanced benefit-risk assessment allowing different assessors and different competent authorities to share benefit-risk analyses, which is an important step in further encouraging an information and data-sharing culture among national regulators. This concept should be taken further by enabling the exchange of information and experiences between those in competent authorities who are involved in the assessment of reclassification applications and encouraging the sharing of assessment reports. 7.9 It is also important to monitor how medicines are used in real life. Pharmacovigilance monitoring gives Member States access to information about the safety in use of medicines that are already available without prescription in other Member States, to assure themselves that national switches elsewhere have not led to an increase in adverse reactions. In some respects, real life use of medicines that have been reclassified in some Member States can be regarded as pilots for other Member States considering reclassifying that medicine. The EU pharmacovigilance legislation provides the opportunity to enhance the monitoring of non-prescription
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medicines through patient reporting of suspected adverse reactions, greater opportunities for post authorisation safety and efficacy studies and risk management plans to be put in place. Post authorisation studies in primary care could help gain insight into the use in practice of non-prescription medicines.
Attitudes of stakeholders
7.10 The attitudes of stakeholders are a key factor in access to non-prescription medicines. Among those countries surveyed, most stakeholders have a positive attitude to non-prescription medicines and reclassification. There is wide recognition among all stakeholders that reclassification of medicines is a benefit to public health as it: enables quicker access to treatments, with no waiting times in doctors surgeries allows more therapeutic choice, particularly for minor ailments frees up doctors time and saves public health funds.
7.11 Safety is a key concern identified, particularly by regulators but also by health professionals and by consumer representatives. 7.12 Patients expect pharmacists to support them in their decisions to choose and use non-prescription medicines and in recognising when medical advice should be sought, and they expect consistent advice from healthcare professionals. Different attitudes and advice, particularly from pharmacists and doctors about self-medication and use of non-prescription medicines can cause confusion and reduce public confidence in self-medication. Support from all health professionals is a key success factor for a reclassification. 7.13 To facilitate a supportive attitude and common approach to non-prescription medicines, the needs and concerns of all stakeholders must be met. Involving pharmacists and doctors early in the process before switches take place would give them the opportunity to raise those concerns and for those concerns to be addressed in a scientific and evidence-based way. Doctors main concerns are based on possible risks of serious underlying conditions being missed. However, use of nonprescription medicines does not mean exclusion of the doctor in care pathways and the development of collaborative care models between patients, pharmacists and doctors will help identify and address safety concerns.
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7.14 Consulting with health professionals before a reclassification can also generate awareness of the switch under consideration and allows them to identify what information or support materials may be needed to enable them to support patients in the safe and effective use of the medicine. 7.15 There are good examples of collaborative care programmes with the support of medical professionals and pharmacists focusing on the education of patients producing positive clinical outcomes. (see Annex 6 on Best Practice.)
Education and training

7.16 Education of pharmacists and doctors in self-care is an important enabler for collaborative care programmes and in supporting patients in general in their choice and use of non-prescription medicines. 7.17 While in all Member States, pharmacists education and training equips them with the required clinical and therapeutic knowledge, the pharmacy profession recognises that effective communication and counselling should be an integral part of pharmacy education in all Member States in order to meet patients expectations. 7.18 Self-care training programmes for doctors were available in only two of twenty countries surveyed. While the medical profession considered that education for selfcare for minor ailments was already covered in the ordinary undergraduate and specialist training programmes for doctors, doctor representatives in 9 countries considered that a self-care training programme would be of benefit and 9 agreed that it would relieve doctors workload. 7.19 Education of patients in self-care is also important. All stakeholders recognise the importance of patient empowerment through education to ensure that people are able to decide when to self-treat and when to seek advice from a pharmacist or from a doctor when the condition is more serious. Education of patients in safe and responsible self-care should be regarded as a life skill whose development should start early. Basic education in schools will prepare the next generation for the future. Availability of high quality impartial information in a variety of forms will help to continue to develop an individuals knowledge of self-care. However, education and the availability of information is only a supplement to the information and support that patients expect to receive from health professionals.
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Advertising and Information

7.20 Advertising of medicines, controlled by law in the EU, plays a key role in increasing awareness among all stakeholders of the availability of a medicine without prescription. There is benefit in advertising regulators in Europe sharing information about how advertising is regulated nationally. 7.21 It is recognised that advertising plays a role in increasing awareness among stakeholders of the availability of a non-prescription medicine but it is important that advertising does not lead to confusion and that patients are able to distinguish between advertising and information. 7.22 Delivering information to patients is an integral part of health literacy and a cornerstone for better health outcomes. Conversely, lack of information about products and self-care in general, and about illnesses that can be treated with selfmedication, is a barrier to access to non-prescription medicines. All stakeholders have a role to play in providing information to patients to support informed use and the correct choice of non-prescription medicines and people need to be encouraged to use trustworthy sources of information. 7.23 Regulation requires manufacturers to provide accurate, high quality, user tested patient information leaflets in the packs of authorised medicines. National Competent Authorities are required, through the EU pharmacovigilance legislation, to increase the accessibility of regulated patient information i.e. SmPCs and Patient Leaflets, by publishing them on their web-sites. 7.24 The Project Group has identified a number of examples of best practice where governments, regulators and health professionals provide empowering information to patients and consumers, through self-care initiatives and programmes, and through dedicated healthcare websites. However, as recognised by EU advertising regulators, such initiatives require considerable resources, which are not available in all Member States. However, the development of the social media (Twitter and Facebook) provides the opportunity for national regulatory agencies to communicate with the public through an increasingly familiar medium and in a cost effective way, to provide information about public health and medicines, and to warn against incorrect information. 7.25 Health professionals also have an important role to provide face-to-face and written advice, which is greatly appreciated by patients and consumers. It is important that health professionals can access accurate and impartial information about non-prescription medicines to support them in their advisory role for patients.
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Economic viability
7.26 It is important to recognise the costs to industry and considerable efforts invested in reclassification and in supporting the introduction into the market of a new reclassification in relation to the limit of a 12 month data exclusivity period in the EU. As reclassifications are increasingly complex with the need for extensive educational and risk management programmes it may be necessary to consider whether further incentives are needed to encourage manufacturers to undertake expensive switch programmes. In the United States and Japan a period of data exclusivity of three years for a reclassification is provided to incentivise research on self-care. 7.27 The commercial risk borne by manufacturers from innovative reclassification is demonstrated in case studies undertaken for pantoprazole, omeprazole and simvastatin which found that, while total sales of all presentations of these active ingredients experienced increases following their reclassification, there was no major growth in sales of the product that was actually switched. 7.28 The low uptake of reclassified products suggests a limited exploitation of the public health benefits of reclassification except for those cases of non-prescription availability of generic versions. If reclassification becomes an unacceptable commercial risk this could inhibit access to non-prescription medicines in the future.
Pricing and Reimbursement

7.29 Since national healthcare systems and reimbursement arrangements are a national competence, pricing and reimbursement policies related to non-prescription medicines vary across the EU. However, improved access could be achieved if all stakeholders had a better understanding of the reclassification process and the range and nature of medicines available as non-prescription. It is important that it is understood that decisions to classify medicines as non-prescription are based on scientific evidence that they can be used safely without medical supervision and that there is no change in evidence of efficacy. Therefore, where reclassification to nonprescription results in that medicine no longer being reimbursed by the healthcare system there is no reason why doctors could not suggest the purchase of a nonprescription medicine if that is the most appropriate treatment considering the patients individual circumstances. This could be addressed through patient information and education, and with the support of health professionals. In 2004 the introduction of the green prescription form in Germany following the dereimbursement of non-prescription medicines allowed medical doctors to continue prescribing (for patients to purchase) non-prescription medicines that were no longer
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covered by the health insurance funds, signalling to patients that these were still effective and safe products. 7.30 Acknowledging the economic and public health benefits of self-medication, other countries implemented measures that incentivise citizens to practise responsible selfcare. These may include tax deductions for out-of-pocket purchases of nonprescription medicines or a self-medication budget (i.e. an amount of money to be spent on non-prescription medicines) as part of the health insurance coverage. 7.31 Different pricing policies may also affect uptake of non-prescription medicines. For example, it may be a disincentive for people to purchase a non-prescription medicine if it was cheaper to visit a doctor and obtain it on prescription. The inability to afford non-prescription medicines can create inequalities between the rich and the poor regarding the right to practise self-care. The absence of pricing controls for nonprescription medicines in Member States may play a role in reducing these inequalities. In examining the pricing of non-reimbursed, non-prescription medicines in 2007, the EU Commission and the EU Pharmaceutical Forum have already advised that Member States should abstain from price control for these products.
8.
Recommendations
Elements of a successful switch

1. Recognising that there are many factors that affect access to non-prescription medicines, Member States evaluating a reclassification should consider the five elements of a successful switch: a. Safety, ease of use and appropriate monitoring for switched products b. A clear beneficial impact on public health c. Responding to the needs/demands of citizens and health professionals, in particular, in terms of patient empowerment, timely access, access to improved treatments and improved quality of life d. Fulfilling unmet needs and addressing conditions that would otherwise remain untreated e. Embraced by health professionals
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Innovation
2. In order to facilitate innovation in access to non-prescription medicines, where appropriate consideration should be given by the marketing authorisation holder early in a products lifecycle to the factors relevant to legal classification needed to be considered in the longer term. Such factors would include the type of evidence needed to support safe non-prescription access. Applications for the change of classification status should be assessed in the light of demonstration of safety in use as a prescription medicine, according to the legal framework.
Early involvement of stakeholders

3. Recognising that a positive attitude and support from all health professionals is a key success factor in making a non-prescription medicine accessible after reclassification, stakeholders should be involved early in the reclassification process so that concerns can be addressed and training prepared.
Collaboration and engagement

4. In order to share experiences and approaches to the regulation of nonprescription medicines, an EU network or Forum should be established for those within National Competent Authorities who are directly involved in the licensing and reclassification of medicines. 5. While recognising that legal status remains primarily a national issue and that some Member States have more active reclassification approaches than others, stakeholders should work together to build on the current list of molecules that are available without prescription across the EU by identifying other molecules and indications that could be acceptable for self-medication in all Member States. 6. Considering a key success factor for access to non-prescription medicines is engagement of all stakeholders and recognising that self-care and selfmedication may develop at different paces within individual Member States, stakeholder platforms should be established at national level to share views and develop strategies to reach a common approach to supporting patient access to non-prescription medicines. Within these platforms, non-prescription champions should be identified from each stakeholder group.
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Pharmacovigilance
7. In order to gain evidence of safety and risks of non-prescription medicines in use, including after reclassification, more consideration should be given to how to make the safety net of pharmacovigilance work well for non-prescription medicines, and stakeholders should develop ideas together on use of post authorisation studies, questionnaires and algorithms within models of supply of non-prescription medicines.
Health professional training

8. Recognising that education of health professionals is a key factor in ensuring safe and responsible self-medication, self-care should be included within the education and training of all doctors and pharmacists. In addition, effective communication and counselling should be an integral part of the pharmacy qualification in all Member States. Furthermore, meaningful continuing professional development for health professionals is a key and is essential if the necessary competencies are to be developed in the context of new reclassifications.
Knowledge and skills of citizens

9. It is important to ensure that individuals have access to health professional advice for appropriate self-care and self-medication, in particular for newly reclassified products. People should also have the opportunity to develop knowledge to look after themselves. Self-medication and self-care should be recognised as an important skill and stakeholders are encouraged to facilitate development of these skills from an early age. In addition, education should also be available to patients through collaborative care programmes to develop an understanding of risks and benefits, and appropriate use of non-prescription medicines.
Information
10. Recognising that lack of availability of information about non-prescription products and self-care, and inconsistency of information from different sources is a barrier to access to these medicines, reliable information should be provided by manufacturers to healthcare professionals in a consistent and complementary manner to ensure that all information that is eventually received by patients is also consistent and understandable. It is important that patients are able to distinguish between advertising and authoritative
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information. To help support patients who move between self-care and the healthcare system, doctors and pharmacists should be informed when a medicine has been reclassified.
9.
Looking ahead
9.1 Finally the Project Group shared an optimistic view at its last meeting, that subject to the views of the Steering Group, the recommendations would form the basis for real and achievable steps to strengthen and promote good governance of nonprescription medicines in the EU to the benefit of all stakeholders.
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References
1. Bodenheimer, Patient Self-Management of Chronic Disease in Primary Care. 2002 2. WHO Guidelines for the regulatory assessment of medicinal products for Self Medication Copenhagen 1980s] 3. PGEU survey on common pharmacist activities, 2011. ref. Joint FIP/WHO guidelines on good pharmacy practice standards for quality of pharmacy services] 4. Vogler et al.,OTC medicines: Switches of active ingredients in Europe in the last decade. EMINeT, 2012 5. Vogler et al.,OTC medicines Distribution 6. Vogler et al., OTC medicines Framework of pricing and reimbursement, EMINeT, 2012 7. Figures based on information provided by AESGP membership, www.aesgp.eu/facts-figures/marketdata/ 8. Development of an information policy for medicinal products, http://www.aesgp.eu/media/cms_page_media/68/FinalReport%20information%20policy.pdf, 2002.] 9. Applicable marketing authorisation procedures: Centralised procedure This procedure results in a single marketing authorisation that is valid in all European Union countries, as well as in Iceland, Liechtenstein and Norway. The European Medicines Agency is responsible for the centralised procedure and applications through the centralised procedure are submitted directly to the Agency. Evaluation by the Agency's scientific committees takes up to 210 days, at the end of which the committee adopts an opinion on whether the medicine should be marketed or not. This opinion is then transmitted to the European Commission, which has the ultimate authority for granting marketing authorisations in the EU. Once a marketing authorisation has been granted, the marketing-authorisation holder can begin to make the medicine available to patients and healthcare professionals in all EU countries. National procedures Member States have national procedures for the authorisation of medicines within their territory. These fall outside the scope of the centralised procedure. Decentralised procedure (DCP) Companies can apply for the simultaneous authorisation in more than one EU country of a medicine that has not yet been authorised in any EU country and that do not fall within the mandatory scope of the centralised procedure; Mutual-recognition procedure (MRP) Companies that have a medicine authorised in one EU Member State can apply for this authorisation to be recognised in other EU countries. 10. Smart Regulation http://www.aesgp.eu/media/cms_page_media/18/SmartRegulation2015.pdf 11. http://www.ema.europa.eu/ema/index.jsp?curl=pages/contacts/CHMP/people_listing_000080.jsp&mid= WC0b01ac05802327cf
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12. http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000310.jsp& mid=WC0b01ac05800986a3 13. http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/ document_listing/document_listing_000314.jsp#section1 14. Brass et al. Improving the Decision-Making Process for Nonprescription Drugs: A Framework for BenefitRisk Assessment. Clin Pharmacol Ther. Dec;90(6):791-803. 2011 15. Dir. 2001/83/EC, Article 10 (5): In addition to the provisions laid down in paragraph 1, where an application is made for a new indication for a well-established substance, a non-cumulative period of one year of data exclusivity shall be granted, provided that significant pre-clinical or clinical studies were carried out in relation to the new indication. 16. Dir. 2001/83/EC, Article 74a.:Where a change of classification of a medicinal product has been authorised on the basis of significant pre-clinical tests or clinical trials, the competent authority shall not refer to the results of those tests or trials when examining an application by another applicant for or holder of marketing authorisation for a change of classification of the same substance for one year after the initial change was authorised 17. EU, Pharmaceutical Forum, Second Progress Report, http://ec.europa.eu/enterprise/newsroom/cf/_getdocument.cfm?doc_id=3352. 2007 18. The EMINet project European Medicines Information Network on Pricing and Reimbursement of pharmaceuticals was launched in December 2008 and is co-funded by the European Commission (DG Enterprise and Industry). It aims to support EU Member States, EEA-EFTA countries and the Commission by providing information, technical expertise and analysis on pharmaceutical pricing and reimbursement policies and related topics. EMINet is established by three partners: 1. Gesundheit sterreich GmbH, sterreichisches Bundesinstitut fr Gesundheitswesen GG/BIG- located in Vienna/Austria (acting as Leader) 2. Andalusian School of Public Health, Escuela Andaluza de Salud Pblica, -EASP- located in Granada/Spain 3. LSE Health and Social Care (LSEHSC) - a research centre in the Department of Social Policy at the London School of Economics and Political Science - located in London/United Kingdom 1 The EMINet project European Medicines Information Network on Pricing and Reimbursement of pharmaceuticals was launched in December 2008 and is co-funded by the European Commission (DG Enterprise and Industry). It aims to support EU Member States, EEA-EFTA countries and the Commission by providing information, technical expertise and analysis on pharmaceutical pricing and reimbursement policies and related topics. EMINet is established by three partners: 4. Gesundheit sterreich GmbH, sterreichisches Bundesinstitut fr Gesundheitswesen GG/BIG- located in Vienna/Austria (acting as Leader) 5. Andalusian School of Public Health, Escuela Andaluza de Salud Pblica, -EASP- located in Granada/Spain 6. LSE Health and Social Care (LSEHSC) - a research centre in the Department of Social Policy at the London School of Economics and Political Science - located in London/United Kingdom 19. Vogler et al., OTC markets in Europe, EMINET, 2012 20. The Forum on Advertising Medicines (FOAM) is a Forum of European advertising regulators from 30 countries (all 27 EU Member States, Norway, Iceland and Croatia). It was set up under the auspices of the Heads of Medicines Agencies. FOAM aims to provide a platform to exchange information about regulatory practice and about advertising cases with cross-border relevance, and to share information
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about how regulatory challenges are addressed in different countries. The focus of FOAM is on practice and procedures for regulation of advertising working within current legislation. Representatives of the Forum work in a variety of organisational roles, often within the inspectorate or enforcement function, or the legal department of their national authority or health ministry. 21. Gauld N Kelly F, Shaw J. Is non-prescription oseltamivir availability under strict criteria workable? A qualitative Study in New Zealand J Antimicrob Chemother 2011;66(1):201-4 22. Vogler et al., Reclassification of medicines from prescription to non-prescription status Findings from interviews with stakeholders in European countries. EMINeT, December 2012 23. Vogler et al.,Impact of reclassification on sales, EMINeT, 2012 24. Delphi study of experts opinions on strategies used by community pharmacists to reduce over-the counter drug misuse 25. Economic and Legal Framework for Non-Prescription Medicines, AESGP, June 2009 26. Self Care Campaign | http://www.selfcarecampaign.org/ 27. Self Care Forum | http://www.selfcareforum.org 28. NHS, Self-Care Week 2012 | http://www.nhs.uk/Planners/Yourhealth/Pages/self-care-week-2012.aspx 29. Self Care Week 2012 resources | http://www.selfcareforum.org/?page_id=1472 30. Self-Care First- A Self-Care Framework for Ireland 2012:Irish Pharmacy Union 31. www.elearning.rcgp.org.uk
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Glossary
This is a non-exhaustive list of definitions. The terms listed are explained in the context of this report and are not necessarily dictionary or legal definitions
Advertising of Medicines:
Activities designed to promote the prescription, supply, sale or consumption of medicinal products Person who voluntarily takes extraordinary interest in the adoption, implementation, and success of a cause, policy, program or project, and acts proactively in accordance with that Framework of rules and practices by which the stakeholders on a specific subject ensure the accomplishment of the desired objective A person who purchases or seeks to purchase a non-prescription medicine A doctor of medicine, a nurse responsible for general care, a dental practitioner, a midwife or a pharmacist within the meaning of Directive 2005/36/EC, or another professional exercising activities in the healthcare sector which are restricted to a regulated profession as defined in Article 3(1)(a) of Directive 2005/36/EC, or a person considered to be a health professional according to the legislation of the Member State of treatment; A substance or combination of substances, used with a view to restoring, correcting or modifying physiological function by exerting a pharmacological, metabolic, or immunological action and administered with the intention of treating or preventing disease, or making a medical diagnosis Medicines which are available directly to the patient/consumer, i.e. can be purchased without a medical prescription
Champion:
Good governance:
Consumer:
Health professional:
Medicine:
Non-prescription medicines:
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OTC:
Over the Counter in the context of this document term used meaning products; non-prescription medicines A person who seeks to receive or receives healthcare (in a Member State) Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem medicines which are available only if prescribed by a doctor Refers to the statutory information i.e. the summary of product characteristics (SmPC), labelling and package leaflet which is approved by the competent authorities for medicines regulation Process that leads to a change in a medicines legal classification (in the scope of this project, from prescription only medicine to non-prescription medicine) Self-care is what people do for themselves to establish, maintain and improve their health, and to prevent and deal with illness and injuries. It is a broad concept encompassing: hygiene, nutrition, lifestyle environmental and socioeconomic factors and self-medication and depending on a variety of environmental and socioeconomic factors Self-medication is the selection and use of nonprescription medicines by individuals to self-treat illnesses or symptoms Same as reclassification Persons who, on a permanent basis, are considered as such because of their mental, physical or psychological disability, age, credulity or gender, and also consumers who are placed in a state of temporary powerlessness resulting from a gap between their individual state and
Patient:
Pharmacovigilance:
Prescription only medicines:
Product information:
Reclassification:
Self- Care:
Self-Medication:
Switch: Vulnerable consumers:
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characteristics, and their external environment, taking into account criteria such as education, social and financial situation. Switch The reclassification of a medicine from Prescription only to non-prescription Unlike in a pharmacy, where both prescription and non-prescription medicines can be sold or supplied, a parapharmacy is a shop selling non-prescription medicines but not supplying prescription only medicines.. Parapharmacies also sell cosmetics, personal hygiene products and medical equipment.
Parapharmacy
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Annex 1
PROCESS ON CORPORATE RESPONSIBILITY IN THE FIELD OF PHARMACEUTICALS Terms of reference for the Platform on access to medicines in Europe
The pharmaceutical sector contributes significantly to the health and well-being of our citizens, but also to economic growth and employment in Europe. Despite the many achievements of the past years, the European pharmaceutical sector is confronted today with major health, economic and scientific challenges. Considering the contribution that medicines provide to the health of individuals, it is necessary to ensure that the pharmaceutical industry strategies are in line with the public health and societal needs and that all partners exercise their responsibilities. The Process on corporate responsibility in the field of pharmaceuticals will be set up to initiate a momentum among the Member States, industry and other relevant stakeholders by considering in a balanced approach societal and industrial challenges. Given the experiences of the G10 process and of the High Level Pharmaceutical Forum, the Process on corporate responsibility in the field of pharmaceuticals should facilitate discussions on ethics and transparency of the sector but also on nonregulatory conditions for better access to medicines after their marketing authorisation. The process will therefore comprise three independent platforms. Transparency and ethics in the sector Access to medicines in Europe, in the context of pricing and reimbursement Access to medicines in developing countries with a focus on Africa
The Directorate General for Enterprise and Industry will manage this process in consultation with other relevant services of the Commission for a period of two years.
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PLATFORM ON ACCESS TO MEDICINES IN EUROPE Scope

Given the diversity of pricing and reimbursement systems and the differences of availability and access to medicines across Europe, it is useful to put in place a European platform for political dialogue and consensus. It is important to recall that pharmaceutical pricing and reimbursement policies fall within the competence of Member States. Each government is responsible for the organisation of its healthcare system and is free to take measures to ensure its financial stability. The principle of subsidiary applies in this field and must be fully respected. The High Level Pharmaceutical Forum welcomed the development of a shared understanding that pricing and reimbursement policies need to balance timely and equitable access to pharmaceuticals for patients all in the EU, control of pharmaceutical expenditure and reward for valuable innovation within a competitive and dynamic market that also encourages research and development. In this context, the platform on access to medicines in Europe will be dedicated to enhance voluntary collaboration among the Member States and relevant stakeholders in order, when appropriate, to find common non-regulatory approaches to enable timely and equitable access to medicines after their marketing authorisation. The platform on access to medicines in Europe will gather a number of concrete initiatives that could in particular facilitate pricing and reimbursement of innovative treatments after their marketing authorisation or that could contribute to a responsible environment for access. Discussions of the platform should be bound by the present legal framework.
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Process
The platform on access to medicines in Europe will be chaired by DG Enterprise and Industry. To support its work, DG Enterprise and Industry might also rely on experts and on organisations involved through the possible nomination of rapporteurs and if necessary, subgroup leaders. Steering Group on Access to medicines in Europe In order to steer the process in a given way, the platform will be driven by a Steering Group. The Steering Group will generate momentum for effective development of the platform by: Overseeing the progress of its projects and by putting forward experienced-based recommendations when a project will be considered concluded.
Exploring how to identify areas with the highest medical needs for a prioritarisation of medicines development in the context of pricing and reimbursement decisions1 and how to characterise innovation2.
Building on its discussions, on the outcomes of its work and on lessons learnt from its projects, the Steering Group should put forward recommendations at the end of its term which should be adopted on a consensus-based manner. Whenever possible, the recommendations should be targeted to specific stakeholders. The Steering Group on access to medicines in Europe will be composed of representatives of the national competent authorities responsible for the pricing and reimbursement of pharmaceuticals and representatives of the stakeholders invited to take part to this platform. DG Enterprise and Industry will chair the group in close collaboration with on going Presidencies of the EU. The meetings of the Steering Group should be organised in conjunction to the biannual meetings of the network of pricing and reimbursement authorities.
This action should be carried out based on the report Priority Medicines for Europe and the World, commissioned by the Dutch Government during their Presidency in 2004, http://whqlibdoc.who.int/hq/2004/WHO_EDM_PAR_2004.7.pdf 2 This action should be carried out based on the Belgium Presidency report Innovation and Solidarity
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Projects on Access to medicines in Europe Projects will be put in place for concepts to be developed and ideas to be tested. Projects will focus on concrete experiences of stakeholders and will explore non regulatory conditions which may impact upon access to medicines after their marketing authorisation. Lessons learnt in each project might feed into recommendations to the Steering Group concerning pricing and reimbursement of medicines. The organisations involved in the platform will have the possibility to volunteer experts, though participate in each project shall be on a voluntary basis Each project should gather a good mix of entrepreneurial, societal and governmental views. Experts involved in a project should ensure its development by sharing experiences, by putting forward case studies and by potentially setting up ad'hoc pilot project. Focused discussions, leadership, active and continued interest, constructive inputs and a flexible approach will be required if useful outcomes are to be achieved. The members of the platform on access to medicines in Europe will be proposed to contribute to the following projects: Mechanism of coordinated access to orphan medicinal products Members will be invited to develop the concept of a coordinated access to orphan medicinal products based on the set up of programmes between companies and groups of competent authorities and results of the ongoing project on a mechanism for clinical added value on orphan medicinal products. A pilot project could be set up in a second stage. Capacity building on managed entry agreements for innovative medicines The objective will be to map the various approaches employing managed entry agreements whose aim is to facilitate access to innovative medicines. Based on the initial mapping, members could pursue the exercise by developing further exchanges of practices and knowledge sharing. Facilitating the supply in small markets The objective will be to clarify the specific non regulatory bottlenecks for the access of medicines in small markets with all concerned parties with a view to defining possible approaches on pricing and reimbursement of medicines and in particular with regards to the processes of launching, distribution and procurement.. Promoting a good governance for non- prescription drugs The objective will be to identify the necessary elements to ensure informed and
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adequate uptake of medicines after a change of their classification from being subject to medical prescription to not subject to medical prescription. The members will in particular investigate the role of competent authorities, pharmaceutical companies, consumers and patients and healthcare professionals. Market access for biosimilars The upcoming emergence of biosimilars may create new market dynamics. The objective of this project will be to define what the necessary conditions within the pharmaceutical environment are to ensure informed adequate uptake of biosimilars. Membership DG Enterprise and Industry will chair the platform. The Member States and EFTA countries will be invited to nominate representatives from their relevant competent authorities in charge of pricing and reimbursement of pharmaceuticals. The following stakeholders' organisations would be invited to take part:
European Patients Forum - EPF Bureau Europen des Unions de Consommateurs - BEUC
Standing Committee of European Doctors - CPME
Pharmaceutical Group of the European Union - PGEU European Hospital and Healthcare Federation - HOPE Association Internationale de la Mutualit - AIM European Social Insurance Platform - ESIP European Federation of Pharmaceutical Industries & Associations -
EFPIA
European Generic medicines Association - EGA European Self-Medication Industry - AESGP
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European Association for Bioindustries - EuropaBio European Association of Full-Line Wholesalers - GIRP
Academics might be invited to contribute to the platform. Experts involved in their personal capacity (academics or others) will be requested to disclose possible conflicts of interest prior to meetings.
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Annex 2
PROMOTING A GOOD GOVERNANCE OF NON-PRESCRIPTION DRUGS IN EU TERMS OF REFERENCE
Introduction: The platform on Access to Medicines in Europe is one of the work areas of the Process on Corporate Responsibility in the Field of Pharmaceuticals. The platform is dedicated to enhancing collaboration among Member States and all relevant stakeholders, in order to find common, non-regulatory approaches to timely and equitable access to medicines, which can be addressed within the current European legal framework. Within the platform, one of the concrete initiatives is the Project Group on promoting good governance of non-prescription medicines in the EU. The objective of the project is to identify the necessary elements to ensure availability, uptake, and informed use and choice of non-prescription medicines, including medicines after a change of classification. The project in particular will investigate the role of competent authorities, pharmaceutical companies, consumers and patients, and healthcare professionals in facilitating such uptake and proper use. The project will be operating in a changing European legal environment in light of the implementation of the new Pharmacovigilance legislation, implementation of the Falsified Medicines Directive and plans for new legislation in relation to Patient Information. Use of routes of entry to the EU marketplace in medicinal products is changing in relation to growing use of the centralised, mutual recognition and decentralised procedures. Patient/consumer behaviour is also changing across Member States, particularly with regard to growing empowerment in self-care, new ways of access to medicines and cross-border patient movement. Among healthcare professionals, the role of the pharmacist has evolved in the healthcare systems. The outputs of the group work are envisaged to include strengthened cooperation between the Member States, exchange of best practice, and attention to barriers to and enablers of success within the present regulatory framework. Where appropriate, recommendations will be made.
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Scope and Objectives:
1) To assess the situation on the ground in relation to access to non-prescription medicines across Member States In most Member States, people manage many of their health problems using non-prescription medicines. However, access to non-prescription medicines varies widely across Member States and a good assessment of the extent of the diversity and of similarities is needed to develop a baseline for moving forward. This will include understanding the pluralism of outlets across the member states. Internet access to non-prescription medicines from legitimate on-line pharmacies and non-pharmacy outlets is becoming increasingly important in some Member States although most information is available only in English. An understanding is needed of peoples expectations and beliefs regarding health and of their responsibility to look after themselves. Challenges to address are the perceived difference in the role of the pharmacist across Europe, the extent of professional supervision of sales of medicines, and how access to and provision of healthcare advice differs between Member States. 2) To identify examples of how access to non-prescription medicines can support patients to take shared responsibility for their own health care Economic constraints on national health services and demographic changes mean that health systems need to optimise the use of all available resources for the benefit of citizens. Improving access to non-prescription medicines, and supporting patients in self-care, can contribute towards a better, more efficient use of resources. This should however not be seen as a substitute for patients access to health professionals services and high-quality care. However, if competent authorities of Member States decide to investigate further the benefits of empowering patients and citizens to share responsibility for their own healthcare there is a possibility for cultural change towards more sustainable use of healthcare resources. Sharing experiences of how nonprescription medicines have contributed positively to increasing personal responsibility for health will provide valuable learning for this project. 3) To identify medicines where non-prescription access has the potential to have a significant impact on public health and to consider what may be learnt from experience of successful and unsuccessful reclassifications It would be helpful to identify medicines that the group thinks have the potential to have an impact on public health and much can be learnt from experiences in other Member States active in reclassification. This should be focused on medicines which, after they have been reclassified, can be made available in all Member States, such as orlistat and pantoprazole, as well as those that are available across a number of Member States e.g. chloramphenicol eye drops.
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4) To consider the barriers and enablers to the uptake, Final - availability, adopted by Steering Group 17/4/2013 informed use and choice of non-prescription medicines, including 4.1) How the current regulatory system operates in relation to nonprescription medicines While there is a common legislative framework for medicines (i.e. the legal status is non-prescription unless a need for POM is identified), the operation of the regulatory system in relation to non-prescription medicines within Europe is influenced by many factors, including national cultures, traditions and attitudes to non-prescription medicines and self care, and different rules within Member States for how non-prescription medicines are accessed by the public. This can have unintended consequences on how the regulatory system operates. Access to non-prescription medicines across Europe is also influenced by globalisation of the industry, increased cross border trade, internet access to medicines, and more movement of citizens between Member States. There is a need to understand better how the system operates and to identify barriers/enablers that may impact on access to nonprescription medicines including medicines which have been reclassified. Consideration is also needed of work already undertaken and of recommendations made (such as the work of WHO and of the CMDh Task Force on Self Medication Project). DG Sanco will be kept informed of discussions and invited to contribute to this work. 4.2) Statutory Product Information
The authorised patient information leaflet is a key tool for patients/citizens to use medicines correctly. In addition to meeting all regulatory requirements, information needs to be clear and comprehensible to build user confidence and ensure appropriate use. The patient information leaflet may also lead to pointers for further non-promotional information about the ailment, other related health matters and diet to aid patients/consumer compliance with treatment and responsible self care. 4.3) Branding
Branding can be both a barrier and an enabler to uptake of non-prescription medicines. People can come to recognise and trust brands, which builds confidence to self-medicate. On the other hand branding, including umbrella branding, can also cause confusion regarding the different active ingredients in a range of products. Solutions to this issue should be explored. 4.4) The role of advertising and media communication about nonprescription medicines, and information to support non-prescription medicines. It is important to maintain a distinction between advertising, which is intended to increase brand awareness, and information, which is intended to inform patients/consumers about the medicine and its proper use. Improved health literacy, coupled with good, balanced, information and awareness of the availability of non-prescription medicines is needed to support patients in
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becoming actively involved their own healthcare. need better Final People - adopted by Steering Group 17/4/2013 information about the resources available to support them. High-quality information about non-prescription medicines is essential if we are to succeed in widening access to non-prescription medicines. Patients need to be confident in their decisions and able to make informed choices, which means being offered reliable, professional advice and high quality information about benefit:risk and safety. Media communication can have a significant impact on the public. The role played by the media should be better understood with the aim to ensure that the message communicated is fair and free of bias and does not cause a potential risk to the public by generating inappropriate behaviours. The role of the regulatory agencies should also be identified as a source of information on the indications for non-prescription medicines. 4.5) Pricing and reimbursement issues
From a patients perspective, access is seen as a function of availability in the market plus affordability. Pricing and reimbursement can affect the uptake of non-prescription medicines. Reclassification can be a disincentive if it results in a product no longer being reimbursed by national health insurance/systems. The price of a non-prescription medicine may also affect uptake if, for example, it could be less expensive for a person to visit the doctor and obtain a prescription than purchase it - even though their condition could safely and effectively be treated with a non-prescription medicine. Care should be given to the communications provided to the public when a medicine ceases to be reimbursed to ensure the reasons for it being dereimbursed are not misunderstood. 5) To explore health professional and patient attitudes and what may support a proactive and supportive approach to self-care The attitudes of GPs, pharmacists and patients to self care and nonprescription medicines are critical to successful uptake of non-prescription medicines. Industry research with pharmacists shows that pharmacists are not embracing every reclassification despite the reclassification receiving support from pharmacy bodies. General Practitioners are not always supportive of reclassifications and can be reluctant to encourage their patients to take more responsibility for their own healthcare. Thought needs to be given to building a positive doctor-pharmacist-patient relationship in order to support patients in taking an active role in managing their health, together with their health professionals. Stakeholder confidence in non-prescription medicines needs to be built and the value they offer all stakeholders fully recognised. Proposed work plan: Analyse factors that contribute to successful and unsuccessful availability, uptake and informed use of a medicine after it has been reclassified.
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Review and undertake research on attitudes of patients and healthcare Final - adopted by Steering Group 17/4/2013 professionals to non-prescription medicines and self care across the EU Review initiatives in Members States to improve access to nonprescription medicines Review approaches to innovation in the non-prescription industry Report on how pricing and reimbursement are affected by nonprescription status Review of the rules in Member States on advertising and provision of non statutory information for non-prescription medicines Review of the education of healthcare professionals in self-care in general, including key competences needed to support patient involvement in their healthcare (e.g. communications, shared decisionmaking), and to support new reclassifications
Methodology: It is expected that members of the Group will take the lead on elements of the work plan with input and support from the rest of the Group. Analysis of case histories of availability and uptake of non-prescription medicines post reclassification Collation of work on attitudes of patients/consumers and healthcare professionals Collation of initiatives and innovations to improve access to nonprescription medicines Ongoing support by EMINet work programme Analysis of the development of the non-prescription medicines sector Analysis of rules in Members States of Advertising and provision of non-statutory information Analysis of education of healthcare professionals to support self care and newly reclassified non-prescription medicines Collect examples of best practice in good governance of nonprescription medicines
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Annex 3 Group Members

Organisation Abbreviation The Czech Republic State Institute for SUKL Drug Control The German Federal Institute for Drugs and Medical Devices Danish Health and Medicines Authority Irish Medicines Board Italian Medicines Agency The Lithuanian Ministry of Health The Portuguese National Authority of Medicines and Health Products The UK Medicines and Healthcare products Regulatory Agency The European Consumers Organisation European Patient Federation Pharmaceutical Group of the European Union Standing Committee of European Doctors European Self- Medication Industry European Association Generic INFARMED BfArM
DKMA
IMB AIFA
MHRA BEUC
EPF PGEU
CPME
AESGP
Medicines EGA
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Annex 4
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63
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68
69
70
71
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Annex 5 - National initiatives to widen access to nonprescription medicines

In response to the need to address the issue of access to non-prescription medicines, Member States are undertaking national initiatives to widen access using a variety of approaches. Czech Republic In the Czech Republic, there are three categories of products which are available without medical prescription: a) Non-prescription (OTC), b) Non-prescription subject to restrictions (OTC subject to restrictions), c) Supply through non-pharmacy outlets (GSL). The definition of non-prescription products subject to restrictions status is laid down in the national legislation, according to which these products do not fulfil the criteria for prescription-only status and they are likely to present a danger either directly or indirectly as they are frequently and to a very wide extent used incorrectly, or their correct use requires necessarily the consultation with a pharmacist. A prescription is not needed for these products, but their supply is restricted in terms of prohibition of supply by mail order, limited amount of active substance per one transaction to one patient, pharmacists obligation to give specific advice to the patient etc. All restrictions set by SUKL (The Czech Competent Authority) are presented in SUKLs decision and they are obligatory. The products containing pseudoephedrine, ephedrine and levonorgestrel (as emergency contraception) are currently approved in non-prescription subject to restrictions category. Regarding the GSL status, the list of substances which can be supplied through non-pharmacy outlets and the maximum pack size for some of these substances for such a supply is set by the national legislation. If the product does not meet the criteria, it can be supplied only in pharmacies (as OTC product). GSL medicines can be sold outside pharmacies, in outlets such as supermarkets, petrol stations etc.; in these areas customers/patients can choose medicines themselves, however, the presence of a qualified person, who has passed an appropriate educational course (according to the legislation), is compulsory in order to give information and advice at the cash desk. There are no special requirements concerning the label design of products available without prescription. The statement of the legal status on the label is not obligatory, but according to the Czech legislation, the instructions for use 73
(indication and dosage) or relevant reference to the Final package have to - adopted byleaflet Steering Group 17/4/2013 be stated on the label. A package leaflet has to contain information on the conditions when the product can be used without medical advice, on the duration of treatment without medical advice and on the circumstances (conditions) during the treatment when the patient has to consult a physician about the use of the product. For all products available without medical prescription the advertising to the general public is permitted. Regarding the pricing and reimbursement of medicinal products, this is in competence of SUKL, who decides on the maximum price and the reimbursement. Products available without prescription are usually not reimbursed. Czech legislation related to the pricing and reimbursement of medicinal products is as follows: Act No 48/1997 Coll., on Public Health Insurance and on Amendments to Some Related Acts, as amended; Act No 265/1991 Coll., on the Competences of the Bodies of the Czech Republic in the Pricing Area, as amended; Act No 526/1990 Coll., on Prices, as amended Price Ruling of the Ministry of Health of December 20 2007, laying down the conditions of price regulation for medicinal products and foods for special medical purposes; Decree No 384/2007 Coll., on the list of reference groups; Decree No 385/2007 Coll., on the list of active substances for adjunct or add-on therapy; Decree No 92/2008 Coll., on the list of the reference basket, method of evaluation of the amounts, conditions and method of reimbursement of medicinal products and foods for special medical purposes and particulars of an application, as amended.
Regarding the switch climate in the Czech Republic, SUKL generally supports the Rx-OTC switches. However, the recent proactive project in which the number of administrative procedures has been started on SUKLs own in order to change the legal status of some substances from Rx to OTC has not been as successful as it was expected. In current practice, the OTC switches are left up to the marketing authorisation holders and the OTC supply is assessed only in those products where it is applied for by the company. SUKL has defined the characteristics of medicinal products designed for the OTC supply. If a medicinal product meets these characteristics, its legal status does not have to be assessed individually. The characteristics of the medicinal products are defined with regard to the active substance, strength, maximum single dose, maximum daily dose, maximum pack size related to
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the content of active substance and indications forFinal OTC supply. - adopted by Steering All Groupthese 17/4/2013 characteristics are published on SUKLs website.
Denmark
Switch projects in Denmark Switch from Rx to OTC (Pharmacy-only) A project on reviewing the medicinal products classified as prescription only with the purpose of a possible switch into non-prescription was initiated by the Ministry of Health in 2010. It was based on the AESGP overview from June 2009 [Ref 25]. The process involved consultation with the Medicines Licensing Board, after which a decision was made by the Danish Health and Medicines Authority (then the Danish Medicines Agency). As a result, it was decided that the following should be switched from prescription only to nonprescription: Hyoscin patches (depot), Calcium + Cholecalciferol, Budesonid 32 microgram og Lodoxamid The timing for switching specific products is decided after consultation with the Marketing Authorisation holders concerned. All products containing the same active substances are switched at the same time. The decisions of a switch is based on the level of a substance in a given form and strength. Switch from OTC/Pharmacy-only to Sales outside pharmacies (change of law 2001) On an ex officio basis twice a year the Danish Health and Medicines Authority reviews medicinal products that are classified as Pharmacy-only products in order to see if they may be switched to sales outside pharmacies. Medicines with a non-prescription status of minimum 2 years are expected to be able to switch to sales outside pharmacies unless special circumstances prevent this, such as the need for professional guidance. AS part of the process the Medicines Licensing Board is consulted and a decision is taken by the Danish Health and Medicines Authority. There has been a political agreement that before a decision is taken there must be a consultation with the different stakeholders (industry, pharmacies, retailers etc.). After the decision on the switch is made, the Marketing Authorisation holders may decide the point in time when the actual switch will take place.
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Germany
Regulatory System for prescription / non-prescription (pharmacy only) classification in Germany. The German Ordinance on Prescription-Only Medicinal Products from 2006, based on 48 of the German Medicines Act, provides a conclusive list of active substances which are subject to prescription. Therefore each medicinal product, containing one of these substances, is classified as prescriptiononly- product. Switch from Rx to OTC (Pharmacy-only) Switches from prescription-only status to OTC and vice versa are discussed twice a year by an Expert Advisory Committee for Prescription-Only Issues (in accordance with 53 of the German Medicinal Products Act), which gives recommendations to the Ministry of Health. The switch concerns the active substance, taking into account e.g. the strength, indication, pack size. The Ministry of Health, in consultation with the Federal Council (Bundesrat), decides about the switch by a delegated, legal binding act. The binding effect is for all medicinal products fulfilling one or several of the published conditions. The procedure involves all stakeholders (health care professionals, academia and industry) and the continuousness of the process guarantees progressive discussion and a high level of market flexibility. OTC Pharmacy-Only and sales outside pharmacies An Expert Advisory Committee for Pharmacy-Only Issues (meetings take place, when required, in accordance with section 53 German Medicines Act) gives recommendations concerning applications for amendments of the Ordinance on Pharmacy-Only Medicinal Products and Medicinal Products Sold outside Pharmacies. In Germany most non-prescription medicinal products belong to the category of pharmacy-only products in order to ensure safe and appropriate use following professional advice by Pharmacists.
Free-sale of medicinal products in drugstores and discounter assortments is possible, but mostly restricted to vitamins and (traditional) herbal medicinal products.
All Advisory Committees are hosted by the Federal Institute for Drugs and Medical Devices (BfArM), but experts from the BfArM are not part of them. Meeting agenda and minutes are published on the BfArM website.
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Ireland
The Consultative Panel on Legal Classification of Medicines was established by the Irish Medicines Board in Dec 2011. This a broad ranging strategy group established to consider the scope of the regulatory function of the Irish Medicines Board (IMB) in relation to the non-prescription medicines sector and how this can be utilised to improve access to these medicines and promote self-care. The group includes representatives from the Department of Health and the Health Service Executive, medical practitioners (Royal College of Physicians and the Irish College of General practitioners) nurse practitioners (An Bord Altranais), and pharmacy representatives (Pharmaceutical Society of Ireland and Irish Pharmacy Union and academic pharmacy). The pharmaceutical industry is represented by the Association of Pharmaceutical Manufacturers Ireland (APMI) and the Irish Pharmaceutical healthcare Association (IPHA). Representatives from the Irish Medical Council and Health Information and Quality Authority (HIQA) also attend the meetings. Patient interests are represented on the panel by the Irish Platform for Patients Organisations, Science and Industry (IPPOSI). To date the group has examined government policy, and socio-economic and regulatory issues which are relevant in determining appropriate access to medicines in the Irish setting. The group is considering a number of initiatives to facilitate a proactive program for identification and reclassification of medicinal products where the need for a prescription is no longer justified. It was agreed that any position that the Panel would reach would be greatly strengthened by independent research in this area and it was agreed that the IMB would commission this research. The group plans to produce a position paper outlining its recommendations for presentation to the Board of the IMB.
Italy
In Italy among the medicines not reimbursed by the National Health Service there is a group widely known as Over the Counter (OTC) medicines for which the prescription is not needed and the patient pays for them. For this particular category the advertising to the general public is admitted. These products are easily knowable because the wording self-medication drug is reported on the labelling. A red label with a drawn smile is reported in each packages of OTC in order to allow a clear identification and to differentiate them from prescription medicines and all health products that are not medicines. As part of the OTC medicines, there are some drugs for which advertising is not admitted for safety reasons. In Italy, since 2008 the prices of non-prescription medicines are freely set by the person responsible for the point of sale (pharmacy, parapharmacy, 77
supermarkets, corner shops). The price must be clearly disclosed to the public Final - adopted by Steering Group 17/4/2013 in the store, using lists or other equivalent methods. Moreover, it is not required to print the price of the drug on the package. Several legislative steps concern the regulation of non-prescription drugs have been set in the Italian pharmaceutical market: Law 24 December 1993 n. 537: criteria of the Italian classification medicines for the reimbursement or not by the National Health System; Legislative Decree 24 April 2006 n.219 (transposition of the EU Directive 2001/83/CE and subsequent amendments and integration): definition of prescription versus non-prescription based for medicines provision; Law Decree 4 July 2006 n. 223: deregulation of non-prescription medicines (part of the non-prescription medicines are also available for sale in non-pharmacy outlets, such as parapharmacies and supermarkets); Decree of the Minister of Health 18 April 2012: first part of the switch from out-of-pocket prescription medicines to non-prescription medicines; Decree of the Minister of Health 15 November 2012: finalization of the switch from out-of-pocket prescription drugs to non-prescription drugs.
As a consequence of the ongoing evolution of OTC distribution across Europe, in Italy since August 2006 all non-prescription medicines can be sold in channels other than traditional pharmacies, such as parapharmacies, supermarkets and corner shops, selling also products like herbal remedies, cosmetics, etc. In these areas customers/patients can chose medicines themselves, although the presence of a pharmacist is compulsory at the cash desk to give information and advices. The most recent legislative disposals concerned the switch of some out-ofpockets prescription-based drugs to non-prescription drugs groups. The Italian Medicines Agency is responsible for the decision to switch medicines from one classification to another. In accordance with the Ministerial Decree 18 April 2012 (G.U. 26.4.2012 n. 97), the Italian Medicines Agency identified 230 packs to switch from out-of-pocket prescription drug list to nonprescription drug list. In order to complete the switch initiated with the first Ministerial Decree, a further Decree (Ministerial Decree 15 November 2012G.U. 26.4.2012 n. 97) was set. At the time of writing, a total of 356 packs switched from out of pocket prescription based-regimen to out of pocket nonprescription regimen. The legislative disposals, in particular the last recent ones, demonstrate that the current Italian legislation is encouraging the growth of non-prescription field even if the general economic crisis probably also has an impact in this area. Moreover, an important aim of a program of switch to non-prescription drugs is to encourage people to adopt appropriate self-care behaviour ensuring an awareness of their own health status.
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Even if particular attention is devoted to the field of non-prescription Final - adopted by Steering Group 17/4/2013 medicines some open important issues must be well studied and solved in the next future. Among the most worthy of attention are definitely those relating to the traceability for non-prescription medicines (in line with the traceability for reimbursable medicines yet applied in Italy) and the monitoring of the on-line pharmacies.
Lithuania
The main requirements for medicines are laid down in the Law on Pharmacy of the Republic of Lithuania. According to this Law, medicines are classified into prescription only and OTC medicines according to definite criteria. These classification criteria are in line with the Directive 2001/83/EC. Retail sale of all medicines is allowed in community pharmacies only. The limited quantity of particular OTC medicines might be sold at one time, that is a quantity needed for 1 month treatment course. Pharmacies are obliged to consult patients assisting in the choice of the right OTC medicine. The main drivers for improving availability of OTC medicines are the following: no need to see a doctor, possibility to start treatment in a very short time, increasing awareness of population in self-care issues, better access to information on medicines, presentation of package leaflets of all authorised medicines in the website of the National Medicine Agency. A very important aspect is a possibility to advertise OTC medicines to the public. OTC medicines are not included in Lithuanian reimbursement system. Their wholesale and retail prices are regulated by mark-ups, approved by the Lithuanian government. Currently there are over 5000 medicines included into National Register of Medicines. Prescription only medicines comprise 83 percent, OTC medicines comprise up to 17 percent. From 2007 till 2011 the number of authorised OTC medicines went up by 5 percent and comprised 833 medicines in 2011. Usually the marketing authorisation holders initiate changes in the classification. In 2007 2 switches to OTC status, in 2008 3 switches, in 2009 10, in 2010 8, in 2011 5 switches were approved. Not all applications submitted by the MAH have been approved. During last 5 years 7 applications were rejected. The most successful switches are related to medicines that are intended for the treatment of chronic diseases or conditions, in particular for the treatment of chronic allergic diseases. Conditions of switches are different. The simplest case is when the package size, labelling, package leaflet and SPC do not need any changes. The second case when there are changes in the list of indications. Usually the list is shortened. The third case when only small packages are reclassified into OTC status. Data on Lithuanian medicines market in packages sold in a wholesale trade. In 2009 up to 47 million packages of prescription only medicines and over 33 million packages of OTC medicines were sold. OTC medicines consisted 41,5 percent of the market. In 2010 there was a light decrease in sales. However, in 79
2011 the sales went up slightly but the OTC market has changed a lot it Final not - adopted by Steering Group 17/4/2013 consisted up to 40 percent of the market. Summary: the number of authorised OTC medicines tends to increase. The sale of OTC medicines in packages has decreased slightly. Future plans: introduction of a distant sale of OTC medicines to the public according to the Directive 2011/62/EU.
Portugal
Switch Projects in Portugal In Portugal medicines are classified into 2 categories: Medicines subject to medical prescription and Medicines not subject to medical prescription/OTCs. The Portuguese Medicines Act classifies prescription medicines according to a set of criteria: level of risk to Public Health, when containing substances under additional monitoring, or administered by a parenteral route. Those falling outside this scope are classified as OTCs. OTC status is based on a self-medication indications list which was defined by Infarmed and stakeholders. This list was enlarged in 2007 and includes 40 self-medication indications (digestive, respiratory, cutaneous and general use) and also CHMP opinions on weight loss and reflux symptoms. Switch from OTC available only on the Pharmacy to Sales outside pharmacies (change of law 2005) The Portuguese Government decided, on 2005, prescription medicines to other sales outlets than objectives related with the reinforcement of the promotion of rational use of medicines and the market competition and price reduction. to widen the sale of nonpharmacies, with the main access to medicines, the also the promotion of the
That means, nowadays, that all OTC medicines are available on pharmacies and general sales dedicated sites. Switch from Prescription Only to OTC In Portugal, the OTC status is based on a self-medication indications list which was defined by Infarmed and stakeholders, within a Working Group defined as Self-Medication consensus Group. This group is responsible for the preparation and update of the Portuguese List of therapeutic indications that can be considered for self-medication and included 10 interested parties: INFARMED, I.P. (NCA), Healthcare Professionals Boards (Doctors, Pharmacists and Dentists), Pharmacy Associations, a Pharmaceutical Industry Association, the Doctors (General practitioners) Association, the Consumers' governmental Directorate and the national Consumers' Association.
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This list was enlarged in 2007 and includes 40 self-medication indications Final - adopted by Steering Group 17/4/2013 (including digestive, respiratory, cutaneous and general use) and also CHMP opinions on weight loss in adults, treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults and chronic urticaria. An Initiative to promote the prescription status harmonization project on reviewing the medicinal products classified as prescription only with the purpose of a possible switch into non-prescription was initiated by the Ministry of Health in 2007-2008. Where, for the same active substance, strength, pharmaceutical form and therapeutic indications there were products classified as OTC and PO, an assessment was initiated to assure the same prescription status to all medicines. This initiative leaded to 176 medicinal products which prescription status switched to OTCs.
United Kingdom
As part of its Better Regulation of Medicines initiative (BROMI) and in response to the UK Governments Red Tape Challenge (to simplify all UK regulations) the MHRA has developed in collaboration with the Pharmaceutical Industry, and following public consultation, a new streamlined procedure for moving medicines from prescription only to non-prescription when it is safe and appropriate to do so. The new procedure is underpinned by a new guideline on How to change the legal classification of a medicine in the UK published in December 2012:
http://www.mhra.gov.uk/home/groups/comms-ic/documents/publication/con213177.pdf
The new guidance includes a new presentational structure aimed at guiding applicants through the reclassification process from product development (within companies) to submission, assessment, approval and risk management activities. With regard to innovative switches the key elements of the new process are: more engagement between the MHRA and applicants prior to submission of an application at concept stage and when the application is developed encouragement of pre-application collaborative work between the applicant and key stakeholders. seeking advice from a stakeholder group prior to consideration by the Commission on Human Medicines consideration of OTC usage data from other EU countries Consideration by CHM of whether subsequent P to GSL reclassification might be possible and, if so, under what conditions
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The guidance also includes a new section on benefitFinal risk assessment to17/4/2013 help - adopted by Steering Group applicants evaluate a candidate product prior to submission, to provide a rationale for their justification that the balance of benefits and risks are in favour of the product as a non-prescription medicine. New appendices present guidance on how to structure applications to be consistent with the European guidelines, together with helpful information on how to avoid common pitfalls and frequently asked questions and answers.
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Annex 6 - National Best Practice examples

As part of its work programme the Group identified and discussed a number of areas of Best Practice that related to improving access to OTC medicines. These included initiatives or models of national best practices as well as specific initiatives.
National initiatives to improve access

UK - Self Care Forum and Self Care week The Self Care Forum is a unique platform bringing together self-care stakeholders in the United Kingdom. Its objective is to further the reach of self-care in the UK and to embed self-care into everyday life, bringing an end to a culture of dependency on the NHS for the treatment of mild to moderate minor ailments. The Forum followed and built on the two years experience and activities of the Self Care Campaign, a group consisting of professionals from the Royal College of General Practitioners, the Royal College of Nursing, NHS Alliance, the National Association of Primary Care and the Proprietary Association of Great Britain. The inaugural meeting of the Self Care Forum took place on 10 May 2011, with the participation of members of the Self Care Campaign and the Minister of State for Care Services, Paul Burstow. The Terms of Reference of the Self Care Forum were agreed at its inaugural meeting and include nine aims with a time frame of 4-5 years to develop, disseminate and promote the outputs of each aim.
Aim Benefit Demonstrating benefit to practices who havent yet got involved with self care can help them come on board The benefits of self care in practice will be important when developing local health strategies There will be an understanding of why practices should support self care in practice
Gather case study examples of self care in practice
Ensure wide communications of case studies to NHS and Directors of Public Health Develop criteria to measure impact of self care for minor ailments
Promote and support professional
The RCGP eLearning module will help to break
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education on self care aware consultations Produce a practice guide of the top ten tips for setting up support for self care in practice. Get health education about self care into the national curriculum in schools Get SCF messages into mass media Develop information about when safe to self care and when not Promote and support Self Care Week 2011 and beyond
cycle of dependency on NHS/GPs Final - adopted by Steering Group 17/4/2013
Important for consistency in messages for patients across practices
Vital for future generations
Need to reach general public This will fill vital gap in appropriate consulting patterns This will provide a focal point for activities relating to self care
Self Care Forum Terms of Reference here
Another part of the work of the Self-Care Forum is to produce a series of Fact Sheets for Minor Illness for use by doctors during consultation to improve self care by reassuring patients about their illness and helping them to identify the red flag signs, which mean that they should seek advice from a healthcare professional. The overall aim is to increase patient confidence in self-care and reduce unnecessary re-consultation with the GPs but ensuring that the red flags are identified. The leaflets aim to address 3 key questions: What do I need to look out for? What is the normal duration? What can I expect to happen? The Fact Sheets are produced using key evidence based resources (NHS, Kings Fund, Patient Information Forum, National Guidelines (including NICE, SIGN, Medical Royal Colleges) Conditions covered include; eczema, heartburn and indigestion, fever in children, constipation, head lice, cough, acne, sprains and strains, sore throat and back pain. Examples of evidence sourced to inform Self Medication Fact sheets for patients:
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COUGHS
90% of coughs last up to three weeks (whether or not treated with antibiotics or chest signs present [ref Cochrane] The same number of patients re-attend at doctors surgeries even if they are given antibiotics [ref Cochrane] Delayed or no prescribing strategy for cough is not an increased risk of developing complications [ref NICE] Antibiotic may sometimes be given if: --Suggestion of complications or --At risk of complications elderly, very ill, comorbidities and/ or significant history [ref NICE]
Key message: 90% of antibiotics last up to 3 weeks and will not be helped by antibiotics unless you are elderly, very ill or have another health condition SORE THROATS 90% of sore throats will clear in a week whatever the intervention [ref Cochrane] Whether viral or antibacterial, antibiotics make little difference [ref Cochrane]
Key message: Most sore throats will last up to 7 days and will clear without antibiotics. Paracetamol or ibuprofen and fluids are the best treatment
[Sources, additional information: Ref 26 27, 28, 29] Ireland Switch-on to Self-Care Working Group The Switch-on to Self-Care Working Group was established in Ireland in 2009 and is comprised of representatives from key stakeholder organisations including the Irish Pharmacy Union, the School of Pharmacy and Pharmaceutical Sciences at Trinity College, Dublin, the Department of General Practice at University College Cork and representatives of the pharmaceutical industry. It also includes an observer from the Health Services Executive (? What is this?). The aim of the Working Group is to
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explore how the benefits to public health and the healthcare system greater Final - adopted by Steeringof Group 17/4/2013 utilisation of self-care and self-medication in Ireland could be more fully realised. To this end the Group has proposed a self-care framework for Ireland, which is based on the following six pillars: Stay fit and maintain good physical and mental health Meet Social and psychological needs Prevent illness or accidents Avoid unnecessary risks Use over the counter medicines to treat minor ailments Reduce the risk of long term conditions
To support the Self-care Framework, the group recommended the following actions: Legislators need to place a high value on the role of self-care in the healthcare system The regulatory environment must be balanced, proportionate, and focussed on meeting the needs and expectations of patients and other stakeholders Healthcare professionals should be encouraged to support and facilitate the concept of self-care The role of the pharmacists should be expanded Patients should have access to good quality information so that they are fully empowered and confident to embrace self-care, seek care at the appropriate level and, thus, enhance their independence within the healthcare system The range of medicines available to patients should be expanded through switching [Ref 30]
Local initiatives
Netherlands - Structured pharmacist-physician collaboration The pharmacist-physician collaboration in the Netherlands started in the 70s and was a voluntary initiative among local pharmacy and medical practitioners. Discussions were primarily focused on practical issues and local concerns. In 1990s this already widespread practice was recognised and supported by the Minister of Health. Co-payment and reimbursement systems were
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introduced to support collaboration between GPs andFinal pharmacists. Nowadays - adopted by Steering Group 17/4/2013 collaboration is supported by IT tools and infrastructure as well as regular face to face meetings. Practitioners, both pharmacists and doctors, who take part in this collaboration, are accredited. Face to face meetings take place 6 times a year and include all the local practices. Agenda are prepared in advance according to identified risk areas or population needs. Increasing focus is given to the joint guidelines for treating patient in certain disease areas: diabetes, heart failure, asthma etc. Prescribing and dispensing indicators are agreed to support it. UK Local initiative to join up self-care between patients, pharmacists and doctors Lancashire North Clinical Commissioning Group has set up a self-care aware programme which aims to: Reduce attendance for minor ailments in general practice Reduce prescribing for minor ailments Support clinical engagement in self-care and through uptake of the RCGP e-learning programme Use patient and public involvement through patient participation groups and ongoing use of local and national self-care campaigns The pilot began in December 2012 with an audit of attendance at doctors surgeries and prescribing. Use of the Self Care Forum self-medication fact sheets commenced .in Jan 2013. This will continue for 18 months and then there will be a re-audit of attendance figures and prescribing of OTC medicines.
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Germany Green prescription Final - adopted by Steering Group 17/4/2013 Efforts to strengthen safe self-medication in Germany: The so called green prescription4
was introduced by a common initiative of DAV, BAH, BPI and KBV5 in 2004, since the reimbursement of OTC products was nearly entirely repealed by GMG ( statutory health insurance modernization law).It provides the opportunity for physicians to give written recommendations on adequate OTC products for treatment. The green color of the prescription sheet clearly indicates that the product has to be paid by the patient and will not be reimbursed. Dosage and duration of treatment can be stated by the treating physician. For these reasons the green prescription has itself established as an additional voluntary instrument to safeguard appropriate OTC application.
5 DAV = German Pharmacists Association = Deutscher Apothekerverband
Source: Gisela Maag: OTC-Markt Trends und Herausforderungen. www. apothekeaktuell.com. Juli 2012
BAH = German Medicines Manufactuers Association = (Bundesverband der Arzneimittelhersteller) BPI = German Pharmaceutical Industry Association = (Bundesverband der Pharmazeutischen Industrie) KBV = National Association of Statutory Health Insurance Physicians = (Kassenrztliche Bundesvereinigung) GMG = statutory health insurance modernisation law (unauthorised translation!) = Gesetz zur Modernisierung der gesetzlichen Krankenversicherung
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Education of Stakeholders Final - adopted by Steering Group 17/4/2013

UK RCGP self care training for GPs The Royal College of General Practitioners has developed An e-learning course for GPs on self care for minor ailments. The course equips practitioners with the knowledge and skills to conduct a self-care aware consultation for patients with self-limiting minor ailments. The course also include strategies for the whole primary care team to improve patient access to evidence based information about minor ailments to enhance patient confidence The course takes 2 hours to complete. [Ref 31]
Informative web sites for consumers

UK - NHS Choices NHS Choices is a NHS website which provides a range of evidence based health information needed to help people make choices about their health from decisions about their lifestyle (such as smoking, drinking and exercise, to finding and using NHS services in England. Features of the web site are an A Z on conditions and treatments, including conditions for self care and when to see the doctor. The web site also includes a section on health living with advice on alcohol, diet and exercise, smoking etc. [Ref: www.nhs.uk]
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Promoting Good Governance For Non-Prescription Medicines

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Promoting Good Governance For Non-Prescription Medicines

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Final - adopted by Steering Group 17/4/2013

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Final - adopted by Steering Group 17/4/2013

Overview and Context

Final - adopted by Steering Group 17/4/2013

Final - adopted by Steering Group 17/4/2013

And Promoting good governance for non-prescription medicines

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The role of non-prescription medicines in self-care

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The important role played by health professionals

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Industry and innovation The non-prescription medicines market

Innovation in the non-prescription medicines market

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Methods and approaches of the Project Group

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Membership of the Group

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explore the switch climate in those countries.

Findings from review of evidence

Map of the non-prescription medicines landscape in the EU

Final - adopted by Steering Group 17/4/2013

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Advertising and media communications Advertising Regulatory Models

On-line networking and social media

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Regulators perspectives on advertising of non-prescription medicines

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Education and Expectations of stakeholders

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National initiatives to widen access to non-prescription medicines

Best practice in improving access to non-prescription medicines

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Success factors, barriers and enablers to access to non-prescription medicines

Elements of a successful switch

Safety, ease of use and appropriate monitoring for switched products

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A clear beneficial impact on public health

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Fulfilling unmet needs

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Health professionals embracing the switch

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Attitudes and knowledge of stakeholders

Differing views between stakeholders

Lack of awareness of the product

Lack of availability of information for patients

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Enablers for a successful Switch

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All stakeholders have a common approach

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A diversity of systems and approaches

Barriers, enablers and success factors