AESGP

Conference Report
AESGP Conference with the Heads of
EU Medicines Agencies (HMA) during
the Maltese EU Council Presidency
20-21 February 2017 | Malta

DEFINING THE PRIORITIES FOR THE FUTURE DEVELOPMENT

OF SELF-CARE
For the 8th time, AESGP brought together the Heads of EU Medicines Agencies to discuss the most relevant
regulatory issues for the consumer health industry. Participants expressed a strong commitment to improve
availability of non-prescription medicines through a more consolidated EU wide approach on switch applica-
tions and by the establishment of an ambitious work plan of the new Regulatory Optimisation Group.

Discussing better market access for non-prescription medicines through regulatory optimisation from LEFT to RIGHT: Hubertus Cranz,
Director General, AESGP; Karl Broich, Director General, Federal Institute for Drugs and Medical Devices (BfArM), Germany; Catarina
Andersson Forsman, Director General, Medical Products Agency (Lkemedelsverket), Sweden; Hugo Hurts, Director, Medicines Evalua-
tion Board (MEB), the Netherlands ; Ian Hudson, Chief Executive, Medicines and Healthcare products Regulatory Agency (MHRA), Unit-
ed Kingdom; Birgit Schuhbauer, President, AESGP; Martin Seychell, Deputy Director General DG SANTE, European Commission.

Helena Dalli
Opening Remarks
In her opening statement, Helena Dalli, Minister for
Social Dialogue, Consumer Affairs and Civil Liberties,
Malta, who in this function is also in charge of medici-
nal products, welcomes participants and underscores
the value of self-care in empowering people to take a
more active role in their own health care, to make
healthy choices and to participate in decisions relating
to their healthcare. This, she says, underlines our duty
to better inform patients on the use and choice of
medicines. The third largest use of the internet is by
people seeking advice on health related issues. Pa-
tients are confronted with a growing volume of infor-
mation from different sources, and it is important to
protect the public. Europe has a network of pharma-
cists who can support patients, and can facilitate the
advancement of self-care. She asks what we are doing
at EU level to enhance the perception of self-
treatment and what can be done to empower patients
and carers to improve their skills. She remarks that a
medicines intelligence and access unit has been added
to the Maltese Health Authority, which supports self-
care by providing objective information for patients to
make informed decisions.
Minister Dalli further explains the role of the prescrip-
tion status working group, which aims to facilitate
switches and promote harmonisation between similar
non-prescription medicines. She refers to the most
recent debate in Malta on emergency contraception
where a final decision was taken to supply it as a non-
prescription medicine. She applauded the European
Commissions report on good governance of non-
prescription medicines, which facilitates in a concrete
manner initiatives to harmonise between Member
States.
Martin Seychell, Deputy Director General, DG Sante,
European Commission draws attention to the main
objective of the conference defining the priorities for
the future development of self-care. He stresses that
the development of self-care should be a key priority.
Member States are confronted with major health
challenges such as how to ensure the sustainability of
healthcare system. Non-communicable diseases ac-
count for 80% of diseases and many of these diseases
are amenable to prevention, early diagnosis and treat-
ment. Patient empowerment is key and patients
should be more autonomous. He advocates for a
patient-centred approach, and stresses the need to
continue to invest in generating better evidence that
self-care can be the answer. Healthy lifestyle needs to
be improved. He notes how Europe is lagging behind
many other regions in this respect. E-health can be
used as a tool to empower patients. Health apps are
increasing daily, which enlarges the possibility for
citizens to make decisions on their own health.
 Session 1
From LEFT to RIGHT: Anthony Serracino Inglott, Chairperson, Malta Medicines Authority; Hubertus Cranz, Director General, AESGP;
Martin Seychell, Deputy Director General DG SANTE, European Commission; Birgit Schuhbauer, President, AESGP; Christa Wirthumer-
Hoche, Chair of the EMA Management Board and Head of the Austrian Medicines and Medical Devices Agency (AGES MEA); Andrzej
Rys, Director, Health Systems, Medical Products and Innovation, DG SANTE, European Commission; Kristin Raudsepp, Director Gen-
eral, State Agency of Medicines, Estonia; Andreja Cufar, Executive Director, Public Agency of the Republic of Slovenia for Medicinal
Products and Medical Devices (JAZMP), Slovenia

Availability of non-prescription medicines

Christa Wirthumer-Hoche, Chair of the EMA Man-
agement Board and Head of the Austrian Medi-
cines and Medical Devices Agency (AGES MEA),
reminds everyone of the references to non-
prescription medicines in the EU network strategy
2020, the HMA multi-annual workplan and the
Working Group on non-prescription medicines.
Anthony Serracino Inglott, Chairperson, Malta
Medicines Authority, opens his presentation with a
reference to Michael Crichton, a best-selling Ameri-
can author, who published the book Five Patients in
1970. The book describes each of the five patients
through their hospital experience and the context
of their treatment. Crichton recounts a brief history
of medicine until 1969 to help contextualize hospi-
tal culture and practice, and mentions national
healthcare, drug prices, healthcare costs, and
healthcare politics. The increasing cost of
healthcare is a major theme which was then at
15% per year. It draws attention to important
themes today, such as access to healthcare, and
explains the importance of self-care. He offers a
possible answer to the eternal question of wheth-
er a medicine be classified with a prescription or
non-prescription status. This depends on risk as-
sessment. Risk management (like in the aviation
industry) is a better approach to risk perception. In
his presentation, he also refers to the practical
application of risk management principle for non-
prescription medicines through the BRASS model.
He ends by noting the importance of striking the
right balance between empowering patients whilst
guarding them from inappropriate decisions.
Andreja ufar, Executive Director, Public Agency for
Medicinal Products and Medical Devices (JAZMP), Slove-
nia, in her presentation describes the issues on availabil-
ity problems in her country. In Slovenia, there are two
types of dispensing sites: Pharmacies and specialised
shops. Pharmacists and pharmacy assistants both have
specific obligations to provide advice when dispensing
medicines.
76 Active Pharmaceutical Ingredients (APIs) are available
as non-prescription medicines in 2017 (which accounts
for around 10% of the total pharmaceutical market). She
explains that non-prescription medicines can be brought
on the market through switches from prescription to non
-prescription status or by introducing new non-
prescription medicines on the market. Opportunities for
switches include advertising, sales promotion through
pharmacies and no price regulation. Obstacles to bringing
more OTC products to the market, include the obligation
for additional studies to justify reclassification, post
marketing authorisation costs and limited comparative
advantages to existing non-prescription medicines. The
limited selling sites and limitations in the product design
and labelling are other barriers to introducing non-
prescription medicines on the market. Other possibilities
for switching to medical devices/food supplements do She concludes her presentation by highlighting the next
not require additional studies to justify reclassification,
involve lower post marketing authorisation costs and are
in general less regulated. She then provides examples of
how the quality of food supplements are less regulated
than medicinal products (e.g. of monakolin K (lovastatin)
and melatonin). There is also the question of whether
Icelandic moss is a medical device or a medicinal product.
She also emphasises that it is important to retain non-
prescription medicinal products on the market. She ends
her presentation by explaining the retail/pharmacy
pricing of self-care products in Slovenia and that the
pharmacy fee for services including dispensing of a non-
prescription medicine is 1.8 Euro.
In her presentation, Kristin Raudsepp, Director General
of the Estonian State Agency of Medicines, focuses on
the European discussions around availability of medi-
cines.
One of the selected priorities for 2016 in the Multi An-
nual Work Plan of the Heads of Medicines Agencies
(HMA MAWP) is the availability of appropriately autho-
rised medicines, and Estonia is a theme leader in this
priority, supported by Spain and France. At one of the
2016 meetings, a mapping exercise of ongoing actions
and future plans took place and lead to the establish-
ment of the HMA/EMA Task Force on availability of
authorised medicines for human and veterinary use. The
terms of Reference of the HMA/EMA Task Force on
availability of authorised medicines for human and vete-
rinary use were adopted by the HMA in November 2016,
and presented at the EMA Management Board in Decem-
ber 2016. The task force has a thematic organisation:
Theme 1: Marketing of authorised medicinal products;
theme 2: Supply Chain Disruption; theme 3: Communica-
tion; 3.1. Internal communication and 3.2. External com-
munication and transparency.
In her presentation, she describes the different kinds of
availability problems: medicinal products not authorised
(not in the scope of the task force), medicinal products
authorised, but are not marketed or no longer marketed,
medicinal products are authorised and marketed pro-
ducts, but supply chain disruptions directly limit availabi-
lity, GMP manufacturing difficulties etc. and explains the
shortage with paracetamol suppositories, which was
resolved in the end.
steps. The EU regulatory network reflection paper will be
published on the HMA and EMA websites. The multi-
annual thematic action plan will be adopted by the Task
Force in Q1 2017 and will be shared with the relevant EU
committees. A Virtual group will also be established
and convene in Q1 2017.
Andrzej Rys, Director, Health Systems, Medical Products
and Innovation, DG SANTE, European Commission
presents the EU Legislative and Policy Developments to
improve availability of medicinal products.
He begins by describing the STAMP (Safe and Timely
Access to Medicines for Patients) initiative which was set
up to tackle the issue of access to medicines.
He moves the discussion to the re-classification of Cen-
trally Authorised Products (CAPs). The legal framework
(extended optional scope of Regulation 726/2004) allows
changes of legal status from prescription-only to non-
prescription for CAPs. But in practice the number of
switches of the legal status in the Centralised Procedure
is very low in relation to the overall number of products
authorised. As part of its reporting obligations, the Com-
mission should publish by 2019 a general report on the
experience acquired as a result of the operation of Cen-
tralised, Mutual Recognition and Decentralised
Procedures. An external study that will provide evidence
for the Report may look into the underlying reasons for
the low use of switch of the legal status.
A report on current shortcomings in the Summary of
Product Characteristics (SmPC) and the package leaflet
(PL) and how they could be improved in order to better
meet the needs of patients and healthcare professio-
nals will also be published. Two external studies
(including stakeholder surveys) will provide evidence
for the Report: (1) Study on the PL and SmPC of Medici-
nal Products for Human use ("PIL-S study") (2) Feasibili-
ty and value of a possible key information section in
PL and SmPC of medicinal products for human use
("PILS-BOX study"). The Draft Report is being finalised,
and will be adopted by the end of March 2017, publis-
hed and submitted to the European Parliament and
Council.
He also reports on the implementation of the Falsified
Medicines Directive (FMD), which includes the intro-
duction of a common logo for online sales of medicinal
products and EU-wide rules for the importation of
Session 2 Hugo Hurts
Regulatory optimization and non-
prescription medicines
Hugo Hurts, Director of the Medicines Evaluation
Board (MEB), set the scene for the session by
pointing out that optimisation of the regulatory oper-
ations of the network is one of the 11 key business
priorities of the HMA MAWP. Out of the 67 actions of
the HMA MAWP, 21 are connected with regulatory
optimization, which underlines its importance. The
MAWP actions aim to reduce regulatory burden,
capture the needs of stakeholders and improve
mechanisms for dialogue in the network. He introduc-
es the discussion on the Regulatory Optimisation
Group (ROG), which in the short term, aims to devel-
op a few concrete business cases, starting with Type
1A variations. He stresses that the aim is not to over-
haul existing legislation but this might ultimately be
required, and warns against high expectations regard-
ing the output of this group.
active substances. All imported APIs must be accompa-
nied by written confirmation of compliance with GMP
standards equivalent to those of the EU. The EU will
perform an assessment of the equivalency of GMP
rules and practices in the 3rd Party Country. Active
substances from such countries considered to have
equivalent GMP standards, do not require written
confirmation.
He also mentions the revision of the Commission
Directive on GMP for finished products, which was
triggered by the entry into force of Regulation (EU)
536/2014. The draft text of the directive replacing
Directive 2003/94/EC was until recently in public con-
sultation. The next step is for the Commission to pre-
pare for a Standing Committee voting procedure. The
GMP package (Commission directive and regulation, as
well as the guidelines on GMP for API) will be publis-
hed together in Q2 of 2017.
Dr Hubertus Cranz, Director General of AESGP, be-
gins his presentation by drawing attention to the
AESGP Self-Care Agenda 2020, which was discussed in
its draft form at the last AESGP conference with the
Heads of EU Medicines Agencies and then launched in
June 2016 at the AESGP Annual Meeting in Athens. It
sets goals for 2020 to create more incentives for
innovation in self-care, reduce administrative burden,
use procedures for market access efficiently, enhance
co-operation between stakeholders and establish
evidence based polices for non-prescription medi-
cines. The AESGP Self-Care Agenda is based on the
assumption that no change in pharmaceutical legisla-
tion is envisaged until 2020, and the focus in the
interim is on improvements in the implementation of
existing rules. He also stresses the importance of
proportionate regulation and asks whether the imple-
mentation of the current legislation sufficiently ac-
counts for the particularities of non-prescription
medicines and well-established substances. He ques-
tions further whether the benefit-risk methodology
for non-prescription medicines is up-to-date and
explains that the Brass et al. model introduced a
benefit-risk evaluation for non-prescription medi-
cines, which fully incorporates the benefits of a non-
prescription status and which should be exploited
more in the context of switch applications from pre-
scription to non-prescription status.
Part of the model is a systematic and consistent
review of data and a well-organized exchange be-
tween applicants and the authorities.
Use of the new telematics system and databases may
decrease variation procedures and can by that facili-
tate product maintenance. He stresses that new
requirements concerning well-established substances
should be limited to those having a real/major positive
impact on the product and with an adequate transi-
tional phase. Pharmacovigilance measures should also
be tailored to the safety profile of the product.
Product information is key for non-prescription medi-
cines; clear and easily understandable information is
vital to ensure correct use. Regarding the eleaflet
initiative, he stresses that both the printed and elec-
tronic format should co-exist for non-prescription
medicines and emphasises the supportive role of
healthcare professionals.
Karl Broich, Director General, Federal Institute for
Drugs and Medical Devices (BfArM), Germany, starts
off his presentation by describing the factors consid-
ered when determining the legal status of supply for
medicines in Germany. A substance-based approach is
used and the criteria are laid down in the German
Medicines Act (Arzneimittelgesetz).
Karl Broich
In Germany, medicines subject to prescription are
those which are not generally known in medical
science, substances able to directly or indirectly harm
patients when given without medical supervision, and
substances with a high potential for abuse/misuse/off-
label use when this is associated with harm and are
listed in an annex to a legal regulation
(Arzneimittelverschreibungsverordnung).
Classification decisions are taken by the Ministry of
Health in a legal act, except in cases where a subs-
tance not generally known in medical science is
affected (such a substance is automatically subject to
medical prescription), and prior consultation of an
Expert Advisory Committee is warranted. The com-
mittee is composed of stakeholders and experts in the
field (academia, clinical practice etc.) and BfArM acts
as "secretary/contact point for this committee.
A national switch procedure exists in Germany (which
is not applicable to centrally authorised products) and
is performed twice a year. He describes the steps
involved in the procedure; that a company or any
other party can submit an application to change the
legal classification, if there is good evidence that the
substance does not harm patients when given without
medical supervision. An application is sent to BfArM
for validation and scientific assessment, and the appli-
cation together with BfArM assessment is then consi-
dered by the Expert Advisory Committee. The com-
mittee can consult further external experts on a case-
by-case basis for specific topics and then issues a non-
binding recommendation as to whether the legal
status should be changed. The recommendation is
addressed to the Ministry of Health and a final deci-
sion is taken by Ministry of Health.
He then reflects on the different approaches and
models for reviewing OTC switches and explains that
from his perspective many requests of AESGP have
been or are about to be fulfilled.
Ian Hudson, Chief Executive, Medicines and
Healthcare products Regulatory Agency (MHRA),
United Kingdom, opens his presentation by explaining
the Joint HMA & EMA Network Strategy, published in
December 2015, which was the first time that a single
strategy for the whole network was developed. This
reflected the need for a coordinated approach to
address the multiple challenges and opportunities
facing the network.
Ian Hudson
He further elaborates that the joint network strategy
focuses on improving access to well established medi-
cines including generics, biosimilars and non-
prescription medicines and ensuring mechanisms are
in place to allow the safe reclassification of products
to non-prescription status. The HMA Multi-Annual
Work Plan (MAWP) describes 11 overarching priorities
to support the delivery of the Network Strategy and
was published in March 2016. These include the avai-
lability of appropriately authorised medicines, interna-
tional collaboration, optimisation of the regulatory
operations, implementation of the telematics strategy
and support for better use of medicines.
He notes that a key element of the work plan for non-
prescription medicines is optimising the operation of
the network. A Regulatory Optimisation Group (ROG)
was introduced to fulfil MAWP actions related to
optimising the regulatory network, and it is currently
developing a Work Plan under the HMAs MAWP
actions that have been assigned to it (which still have
to be confirmed).
It is intended that the ROG will identify problems
relating to business optimisation and conduct investi-
gative and analysis work into these problems. Business
cases can then be developed outlining the problem
and proposing recommendations to optimise the
regulatory process(es), which can then be presented to
the HMA and / or EMA for approval.
He further outlines the MAWP actions assigned to the
ROG:
to identify valuable old or niche products that fulfil
medical needs which may have a critical relevance
for the health systems and patient care and there-
fore require enhanced support (Action 2) to stay
on the market (for example by providing incen-
tives to industry);
the effective use of IT systems at national and EU
level (Action 43) to maximise efficiency and mini-
mise burdens through taking a strategic approach
across the network (EU telematics, CESP). He
mentions the example of SPOR which could be
utilised to reduce the number of variations;
to explore mechanisms to effectively disseminate
information and input to the network on the
outcomes of international fora (Action 55);
for the HMA to continuously explore harmonisa-
tion of criteria and remove unnecessary national
requirements to reduce the administrative burden
of the registration processes in Member States
(Action 15);
to initiate efficiency reviews of HMA procedures to
be overseen by relevant HMA groups (Action 38);
the optimisation of the regulatory framework
(Action 39) within the current legislative provi-
sions, including continuing to collaborate to re-
duce regulatory burden where appropriate. Im-
prove mechanisms for dialogue between Member
States on burden reduction and capture and un-
derstand the needs and expectations of the net-
works stakeholders (for example by investigating
DCP / MRP processes, identifying process pain
points and inefficiencies for regulators and in-
dustry and reviewing variations to identify areas
for improvement).
He reflects on progress already made. For example,
the majority of actions within the MAWP have been
incorporated into the objectives of existing working
groups. Clear business plans have been put in place for
the delivery of actions in the MAWP by these groups.
Further on leads assigned for each HMA priority are
overseeing progress and provide progress updates at
each HMA meeting. Progress will be reviewed against
the timescales set out in the 5-year plan. It was ack-
nowledged that some new groups might need to be
established. Over the past twelve months the propo-
sals for new working groups have been reviewed and
groups established including the ROG each with a
clear mandate and terms of reference.
He describes some UK Initiatives to support reclassifi-
cation such as the National Stakeholder Platform on
Reclassification of Non-prescription Medicines and the
joint working with the industry to streamline and
improve the reclassification process.
Catarina Andersson Forsman, Director General, Swe-
dish Medical Products Agency (MPA)
(Lkemedelsverket), Sweden, reflects on the question
How does a national agency fulfil the EU common
strategies. She presents the MPA strategy which
draws on the EU telematics strategy, the HMA MAWP
and the Swedish government.
Catarina Andersson Forsman
Helen Vella, Member of the Co-ordination Group for
Mutual Recognition and Decentralised Procedures-
Human (CMDh), Director, Licensing Directorate,
Malta Medicines Authority explains that discussions
have been ongoing at the CMDh level with AESGP for
some time and that these are based on the general
consensus that changes to the legislation are not
envisaged in the next few years.
The CMDh Strategy to 2020 aims to facilitate easier
access to OTC-products by exploring possibilities for
MRP/DCP procedures for OTC products (especially in
procedures where legal status is different in Member
States involved). In the short term, the Best Practise
Guide for the authorisation of non-prescription medi-
cines has been updated. Longer term goals will be
achieved through the creation of a specific working
group to discuss ways of collaboration and finding
workable solutions for MRP and DCP.
She explains that the CMDh Non-prescription Medici-
nal Products Task Force (TF) was set up at the end of
2016. The chair of the TF is Virginie Bacquet (France)
and it includes several members from different Mem-
ber States (CMDh members or other experts in this
field e.g. from switching bodies). The main aim of the
Task Force is to explore new ways to improve conver-
gence on evaluation and facilitate the access to the EU
patients to safe and effective non-prescription medi-
cines. The Task force will give recommendations to
the CMDh and the HMA to enable wider approval of
non-prescription medicinal products by enhancing
sharing of best-practices by both the national compe-
tent authorities and the industry, revising the relevant
Best Practice Guide on the DCP for non-prescription
medicines if deemed necessary, and engaging with
relevant trade associations to discuss non-prescription
status at the European level.
Current discussions are focusing on:
Best practices for non-prescription medicines
provided by AESGP for wider adoption. She des-
cribes a number of examples where AESGP has
identified problems during procedures and sought
to find solutions within the existing legal frame-
work. For example, merging and splitting, how to
run a MRP/DCP procedure with a difference in
legal status across Member States including the
possible applicability of the BRASS model, and the
possibility for different legal classifications bet-
ween the originator product and generics on the
basis of submission of acceptable data (e.g. for a
switch by a generic applicant);
How to facilitate moving medicines
from prescription to non-
prescription status
Session 3
Zaide Frias
Helen Vella
Training for assessors or a joint training for asses-
sors/switching bodies. Member States are re-
quested to make proposals for active substances /
pathologies that would be candidates for non-
prescription status and to contribute to informa-
tion gathering exercises (led by AESGP) for a list of
substances/indications that are already non-
prescription in the Member States.
It is proposed to share information on requests for
scientific advice for switching with the other Member
States and their outcomes. Requests for scientific
advice should also be discussed well in advance with
the Reference Member State (RMS) and the Concer-
ned Member State (CMS) liaising with the EMA and
Multi-stakeholder Scientific Advice procedure for
switches and switching bodies at national level. There
is also the possibility of some new guidance for appli-
cants specific for pre-submission discussions between
the applicant, the RMS and the CMS.
The next steps are to decide which proposals should
be taken forward, to consolidate the work on these
proposals, to define pragmatic solutions and to conti-
nue with and to build on the collaboration with the
stakeholders.
Zaide Frias, Head of Human Medicines Evaluation Divi-
sion, European Medicines Agency presents the consider-
ations around the new Joint EMA/CMDh multi-
stakeholder Scientific Advice procedure for OTC switches,
which is co-led with Peter Bachmann (CMDh chair/
BfArm) and set up to explore other ways to reach agree-
ments between Member States regarding non-
prescription products and to facilitate a greater number
of harmonised product switches at EU level. It is con-
cretely reflected in action #16 of the HMA Multi Annual
Work Plan (MAWP) and in action #7 of the CMDh MAWP.
She describes the challenges with facilitating switches
such as significant discussions concerning patient misuse
or abuse, self-diagnosis, masking underlying conditions
and differences in risk perception and a main barrier to
switches is the differences in health care systems and
possibly healthcare professional and patient attitudes.
She reiterates what was said before about the im-
portance of the role of the pharmacist in facilitating
switches.
The joint EMA/CMDh initiative proposes to use the
well-established EMA scientific advice procedure
across the lifecycle. The advantage of the procedure is
that it activates the right expertise through the Scien-
tific Advice Working Party (SAWP) and the establish-
ment of an OTC expert forum group and allows de-
bates on switches across the lifecycle of the product-
addressing switch by design how to expand switches in
more Member States and exchange on OTC real world
experience. She notes that currently a EU forum where
national switching bodies can participate does not
exist. An OTC Expert Forum could provide a platform
for discussion to mobilise EU Network experts and June Raine
expertise and include patients, pharmacists and physi-
cians. The next steps on the composition and function- June Raine, Chair, European Medicines Agencys
ing of the OTC expert forum, expectations from Indus- Pharmacovigilance Risk Assessment Committee, and
try and EU Regulators and the running of a Joint EMA/ Director of Vigilance and Risk Management of Medi-
CMDh Multi-stakeholder scientific advice procedure cines at the Medicines Healthcare products Regulato-
will be discussed at a stakeholder workshop scheduled ry Agency (MHRA) of the United Kingdom reflects on
for the second half of 2017. what has been done at EU level to facilitate switches
which could be used as a springboard to create a
Lilian Azzopardi, President, European Association of national platform looking at the prerequisites for
Faculties of Pharmacy, Department of Pharmacy, success which is the focus of her talk. She stresses the
Faculty of Medicine and Surgery University of Malta importance of a collaborative working relationship
shares her reflections on pharmacy education in Eu- with the industry to simplify processes and effective
rope. risk management. She draws attention to the excellent
report of June 2013 on good governance of non-
prescription medicines, which outlines key areas for
the development of self-care industry including access
to information, and training and education. This report
was endorsed by all stakeholders and is still an impor-
tant point of reference.

In the UK, the 5-year forward view includes a national

strategy to support self-care. She also notes that
currently there are three switches coming through,
which are not yet public knowledge.

Lilian Azzopardi

The European Association of Faculties of Pharmacy

(EAFP) did a mapping exercise of pharmacy curricular
requirements. The study showed a shift away from an
emphasis on Chemistry (which represented the largest
subject in 1994) towards the medical sciences (in
2006) which incorporates non-prescription medicines,
therapeutics and responding to symptoms. Ireland,
France and Malta have the highest range of pharmacy
practice oriented courses. The EAFP has liaised with
EPSA (The European Pharmaceutical Students associa-
tion) to discuss with the European Commission and the Lorraine Nolan
EU facilities of pharmacy on how to advance areas of
clinical pharmacy practise to support self-care. She Lorrain Nolan, Chief Executive, Health Products Regu-
explains that self-care has always been at the heart of latory Authority (HPRA), Ireland begins by presenting
the pharmacy profession and that educators should the changing population dynamics. The aging popula-
recognise the changes in the profession, especially tion is growing, managing polypharmacy is becoming
regarding switches. increasingly complex and healthcare resources are
stretched.
In 2011 an independent consultative panel on legal
classification of medicines was set up and developed
recommendations in 2013. In 2014, the HPRA list for
switches was drafted and 12 APIs were identified for
switch. A proactive approach to switches has been
reflected in the recently updated HPRA Guide to Re-
classification, which was first published Oct 2010.
Promoting a better regulation approach to effective
legislation in many areas including mechanisms to
facilitate reclassification of medicines is a key priority
of the HPRA Strategic Plan 2016-2020, and like June
Raine she also refers to the important results of the
work of the European Commission Platform on Access
to Medicines in 2013.
Future of self-care in a connected
world (big data, eHealth data pro-
tection and empowered patients)
Session 4
Guido Rasi
The last session addressed self-care in a connected
world, which encompasses big data, real world data/
evidence, ehealth, data protection and the recurrent
theme of the conference-patient empowerment.
Guido Rasi, Executive Director of the European Medi-
cines Agency, opened up the session by stating that
real world data will inevitably have to be addressed in
the future, and acknowledged that both challenges
and opportunities lie ahead with its management. He
recalls that this journey began at the EMA at a work-
shop on 14-15 November 2016, and led to the for-
mation of a joint group between the HMA and EMA to
address big data challenges, chaired by Thomas
Senderovitz and the EMA. The other tool developed to
manage the telematics strategy is the Regulatory
Optimization Group (a joint HMA/EMA initiative). He
concludes by alluding to social media and other big
data source and challenge.
She gives examples of recent switches in Ireland such
as Buscopan, and Nasocort allergy and presents the
barriers to switches such as time, complexity in terms
of small markets, commercial factors such as global
decisions, reimbursement, the lack of a central patient
medical record database, differences across Member
States, healthcare systems, product names and pro-
duct versus substance based reclassification. Other
important elements are future considerations such as
the appropriate infrastructure- records and databases,
the political appetite for a competent authority forum,
the engagement with key stakeholders, the continued
upskilling of pharmacists, buy in from medical profes-
sionals, reviewing reimbursement nationally and
across Europe and utilizing available resources effi-
ciently.
Andrzej Rys, Director, Health Systems, Medical Pro-
ducts and Innovation, DG SANTE, European Commis-
sion begins his presentation by describing that digital
health is perceived holistically in the European Com-
mission and it should be considered from a resources
point of view (financial capital), from a services point
of view (telemedicine, telecommunication, telework-
ing) and from the patients point of view and by that
as a way to strengthen patient empowerment. As
already mentioned, he notes that the digitalization of
the pharmacy profession and the needs of the patient
has already been taken into account in the curriculum
for the next generation of pharmacists.
He reflects on developments in healthcare with the
introduction of mHealth apps, digital ECGs, digital
biomarkers and distance consultations, for example.
Although a vast amount of digitalization exists, he
acknowledges the data protection constraints and that
we still dont know how to use it.
EHealth and mHealth solutions can facilitate patient
empowerment and can be the catalyst to move
healthcare from doctor-centered to patient-centered
care and allow patients to make informed and appro-
priate decisions on their own health and wellbeing. He
describes the challenges around big data, which are
often unstructured and largely inaccessible (stored in
poorly curated repositories or silos). He draws atten-
tion to the analogy of the evolution of digital pictures
and how in the future we will be able to perform some
tests and preoperative procedures in the virtual reali-
ty. He refers to a study published on the European
Commissions website entitled How big data can
change the landscape of healthcare.
He describes some related EU activities in digitising
medicines, in authorization, in clinical trials (with the
EU CT portal and database under development and to
a certain extent already accessible to the public), and
refers to the EMA Medicines portal, the implementa-
tion of the falsified medicines, directive online pharma-
cies, the pharmacovigilance article 57 database (which
was a massive achievement but still has a long way to
go in terms of the quality and accessibility of the data
and how it can be used in the future), patient registries
(the European Commission made investments through
the PARENT joint action on registries (2012-2015), the
EUnetHTA 3 Joint Action (2016-2020) and the EMA
initiative on registries), patient information, the elec-
tronic leaflet, electronic prescription, self-reporting
(investigated through the IMI Web-RADR project on
how social media can contribute to pharmacovigilance
activities) and mHealth apps for whichunlike the
FDAself-regulatory approaches are envisaged. A Code
of Conduct on privacy, guidelines on the assessment of
data validity and reliability and CEN standards on quali-
ty criteria for development are also followed. In addi-
tion, there have been some relevant national develop-
ments in this field.
He asks how the activities between authorisation and
monitoring can be connected and how the link between
clinical trials and the increased role of the patient in
clinical trials can be established (including quality of life
measures).
He finishes off the presentation by explaining the
Digital Single Market, which is one of the 10 priorities
of the Juncker Commission. It is in the middle of devel-
opment and will provide opportunities for health and
digital care. This action is coordinated by the European
Commissions Vice President Andrus Ansip and a Com-
mission Communication is planned on 10 May 2017.
Beln Crespo
Belen Crespo, Executive Director, Agency for Medi-
cines and Health Products (AEMPS), Spain, emphasizes
the importance of topics around availability, innova-
tion, regulatory optimization, and switching from pre-
scription medicines to non-prescription medicines as
topics already discussed. She moves the discussions to
the information provided to patient and healthcare
professionals. She begins by stating that the way citi-
zens accede to medicines information is changing. They
are more empowered to self-care using electronic
systems, and information is no longer the same any-
more. In the case of non-prescription medicines she
points out that information is the key to good use. The
EMA and national competent authorities are responsi-
ble for being the primary source of this information. If
the information is not adopted to the needs of patients
and healthcare professionals, others will attempt to do
this, which could lead to concerns. At the same time,
she continues, we have to use the information coming
from real world data (clinical reports, e- prescription,
registers) to improve not only the regulation of medi-
cines but also the information given to professionals
and patients. In this area, the regulatory network has
taken up this challenge to transform real world data
into better regulation and better use of medicines, both
aspects are included in the 2020 strategy of the Net-
work and MAWP.
She then focuses the discussion on support for better
medicines use, which is one of the eleven key business
priorities of the EU medicines agency network strategy
to 2020, and is led by Norway and Spain.
She refers to Spains working programme to look close-
ly at the content of information currently provided to
patients and healthcare professionals, and to analyse
the new tools, approaches and contents of healthcare
information that could be provided in a clearer and
more educational format.
She discusses the eprescription system in Spain which is
fully implemented. The health system is managed by
the 17 regions in Spain, not by the central government.
She explains that the main problem with eprescriptions
is with the interoperability of systems between the
regions, which is currently being addressed with prom-
ising results. They are also working on interchanging
information on clinical reports (which has been imple-
mented in some regions in Spain). In Spain, the analysis
of over 5 million clinical report data have helped to
detect pharmacovigilance signals.
In Spain, there is also work on the content of eleaflets
and detailed and updated information on the Summary
of Product Characteristics (SmPC), patient information
leaflets (PILs) and videos are available on the web page
of the Spanish Agency of Medicines and Medical Devic-
es (AEMPS). They are also working on barcodes on the
packaging of medicinal products which could transform
the data electronically on mobile phone devices. The
text information is fragmented by sections (it is no
longer in a word document and/or pdf format) which
offers the possibility to easily search and navigate
relevant sections of the SmPC for example. The infor-
mation has also been adopted to accommodate disa-
bled persons, and subpopulations (such as children,
elderly, by gender, by disease).
She concludes by stating that there is a demand for
better information on medicines, which is especially
important for the non-prescription sector. EHealth
prescriptions and the new ways to deal with medicines
information are an opportunity for the EMA and
National Competent Authorities (NCAs). The 2020
strategy and MAWP are tools which can foster change.
Thomas Senderovitz
Thomas Senderovitz, Director General, Danish Medi-
cines Agency (Laegemiddelstyrelsen), Denmark,
presented a definition of big data taken from Wikipe-
dia, that data sets that are so large or complex that
traditional data processing applications are inade-
quate and acknowledges that definitions of big data
can be quite varied. He notes that this definition may
soon be obsolete because of the intended definition of
traditional data processing
He describes the big data health landscape using a
graph with pre-approval and post approval on either
side of a dotted line. He explains that the clinical
controlled sets are becoming extremely large, omics
data are increasing by the day in the pre-approval
setting, because its becoming cheaper and simpler.
The dotted line which represents real world data can
also move.
Traditional functional imaging and remote sensor data
is also increasingly being used in clinical trials. We
know how to analyse the data using bioinformatics but
as the amount and volume of this data is expanding
we need to be able to handle this data. Post approval
data from wearables, patient registries or social media
are largely uncontrolled compared to pre-approval
data. Using self-initiated omics, correlations can be
drawn for example to the medicines taken. This infor-
mation could feed into the cloud. Regulators, patients
and Sponsors should therefore be alert regarding this.
In general, it is not about the data as such, but about
getting meaningful knowledge from it. The big chal-
lenge is to turn Big data into knowledge, and
knowledge into decisions, which have to be made by
regulators, clinicians and sponsors.
He then draws attention to trends in life science gen-
erating big data and disruptive consumer technology
such as wearables, which will soon become cheaper
and readily available. A concern for regulators is how
to access the data generated from these sensors.
Precision medicine is another area, where national
strategies have been developed. But what does it
mean? He explains that ultimately, it will lead to the
generation of more data with whole genome sequenc-
ing, and strategies for companion diagnostic develop-
ments.
There is analytics everywhere and the data created
can at the end of the day be confusing. Cloud compu-
ting is maturing. Machine learning / Artificial Intelli-
gence (AI) is a new trend which will create different
types of data. Healthcare cost reductions can also be
made possible through digitalisation.
He presents a metaphor of a big data avalanche and
explains that it is better to surf the avalanche rather
than get drowned it. 24 months is the current fre-
quency at which electronic healthcare data doubles
and this time frame will most likely decrease in the
next few years. 150+ exabytes of health care data are
available today. 90% of the worlds data has been
created in past 2 years which underscores the chal-
lenge in coming years and signals the exponentiality of
the data generation. As 80% of data is unstructured,
the main question is how can one get meaningful data
from this.
He refers to a picture of an individual with 1100 tera-
bytes generated per lifetime, which is likely to in-
crease. 10% is from clinical factors (0.4 terabytes) and
the rest is from genomic factors and social, environ-
mental and behavioral factors (the data on which
precision medicine is based). With this large amount
of data per individual, he asks where does the data
end. And who owns the data and who controls it?
He points that in the future with more ehealth data
and real time big data, regulators will be pressured to
make decisions faster, and with the veracity of big
data: Can we trust it at all?
Current data dilemmas are the use of small data (the
current structured trusted clinical data set) versus big
data. With big data, the same statistical methods
cannot be applied when analyzing the data sets and
statisticians and clinicians are uncomfortable with
using this type of data.
He asks, how do we handle messy data vs. clean data?
Can we trust data in the cloud which is uncontrolled,
which is possibility fraudulent and which we cannot
assess/inspect? And if we cannot trust it, can we use
it?
Practical challenges with big data include the multiple
sources and multiple format. He asks if we should aim
to generate standards to control this data., regulated
vs. non-regulated and planned prospective data vs.
random data. Prospective data means that we can
plan the study to come to the conclusion of interest.
However, electronic health records and other large
data sets are not designed to make these conclusions.
The solution he describes, was the creation of the
joint HMA/EMA taskforce on big data. The kick off
meeting is on 6 March 2017 and the objective is to
deliver recommendations and establish its work plan
over the next year and a half. From the mandate, the
task force aims to map out relevant sources of big
data and define the format. That said they do not aim
to investigate the sources of data at a granular level
but to gain a broad overview on what they are dealing
with. He refers to a point made in Andrzej Rys presen-
tation that a lot of data generated can get lost, and
lost data can introduce bias. With the difficulties
implementing SPOR in controlled datasets, what will
this mean for large uncontrolled data sets?
Another aim of the task force is to identify the usabil-
ity/application of the data. He recalls a presentation
from the transport of London at the EMA big data
workshop on 14-15 November 2016, where in the
transport of London they always ask, what are the
decisions we are going to make with the data we
collect.
He asks the floor: What are the regulatory decisions
we have to make as regulators and what are the
decision we should make and should not make? Only
when we know this, we can ask for the data we need.
He goes on to say that we need to describe current
and future state and challenges with the different
capabilities within the national authorities, and skills
set required, for example, if everyone will require the
same skills or if experts in analyzing specific datasets
can be clustered around the EU.
The outcome of the exercise is to make recommenda-
tions, such as legislative changes, regulatory guide-
lines taking into account ethical considerations, com-
petencies, tools/systems and the usefulness of big
data in the regulatory setting. A lot of clinical data
which is costly is currently not used and he concludes
by reiterating that it is pointless and unethical to store
and collect large amounts of data, if it is not used to
support regulatory decisions.
Dirk Ossenberg-Engels
Dirk Ossenberg-Engels, Senior Vice President, Head
of Region Europe South, Central and Eastern Europe
and Middle East, Bayer Consumer Care and AESGP
Vice-President underlines the importance of the
empowered patient. He shares his perspective on
digital health, as the main business sponsor in Bayer
Consumer Care for driving digital and as a EU citizen,
concerned with how future generations will be ena-
bled to digital health in the future. Technology is
advancing rapidly but it is a great opportunity. He
stresses the need for an aligned view on digital health
with regulators, but first and foremost for consumers,
who will ultimately be exposed. Similar to the defini-
tion of big data, he notes that there are many views
on what digital means, focuses the discussion on the
potential role of digital in facilitating switches, infor-
mation gathering, and developing health services,
inclusive of health apps. He stresses the need for
reliable information, as his son and consumers alike
are faced with information from Dr Google to make
decisions. He explains that the industry communica-
tion process is lengthy. He then shares an anecdote on
a promotional measure from one of his countries
which was shared on twitter, and which required the
authorisation number on each line and even had to
get approval to say good morning. He then de-
scribes that in Germany and the Netherlands there is
industry self-regulation which allows for responsible
and meaningful dialogue with patients. It works well
and can be a point of reference to other countries.
Adverse event reporting is also a challenge, but an
obligation when resulting from company websites for
example. However, companies cannot have oversight
on all available data not governed by them.
He provides some reflections on moves to switches in
the given context. With better training for the phar-
macist, patients, and doctors, he believes that eHealth
is an enabler for switches, where there are regulatory
 concerns. He acknowledges the data protection re-
quirements but believes that data which is anonymized,
can be of enormous power.
From an industry perspective, it will require significant
resources to invest in switches and then to provide the
data which will ultimately benefit empowered citizens.
He refers to the opportunity with social media
platforms in facilitating switches. He also alludes to a
Spanish pharmacist blog, and suggests that facetime
consultations could be a suitable eHealth service option
in the future. He mentions some eHealth initiatives
(such as the 7 minute workout app and the 10 th month
of pregnancy app) which are built around consumer
insight. Apps can be product related, disease related or
diagnostic. The main question is whether these need to
be regulated or can they be self-regulated by the indus-
try.
He concludes by stating that consumer behaviour is
changing and technology is changing, and solutions can
only be developed together, and industry is interested
in engaging with regulators and other stakeholders to
reach these solutions to empower people.
AESGP President, Birgit Schuhbauer, closes the
meeting, reflecting on the willingness shown for con-
structive dialogue and clear commitment to empower
citizens in health related issues. She reflects on the
potential role of the pharmacist and the need to be
able to fund innovative developments in healthcare.
She ends by stating that if there is a political will there
is a way to really make progress. She applauds all the
presentations given, thanks all participants and ex-
presses her optimism that there is engagement, com-
mitment and a sense of urgency from the discussions at
the meeting.

Main issues covered during the conference will be:

Mergers and Acquisitions and their impact on the performance of the consumer health industry
Developments in the digital world on how to best respond to
citizens expectations
The future role of health professionals
Market access for non-prescription medicines
Recent developments around self-care medical devices and health claims

Conference venue
Hilton Vienna
Am Stadtpark 1, Vienna, A1030

Advance programme available -

www.aesgp.eu/53

Self care: The first choice in healthcare

7 avenue de Tervuren, B-1040 Brussels | Tel: +3227355130 | info@aesgp.eu