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Risks 2016
KPMG presents our view of
the top risk by value driver
faced by corporates in the
Pharmaceutical sector


October 2016
2016 Risks for Pharmaceutical
Emergence of fast evolving digital technologies, increased regulatory pressure and global economic uncertainty are key factors in the
current risks landscape. KPMG Risk Consulting assists clients to develop robust risk mitigation methods by interpreting the underlying
drivers of global risks.

• Macroeconomic uncertainty in key • Competition arising from non • Inability to attract and retain
markets from factors such as the traditional players providing services qualified personnel while
UK's vote to leave the EU (Brexit), on digital health technology i.e. appropriately managing costs
economic recession in Brazil and telehealth, mhealth, wearables and related to employee benefits.
Russia and slowdown in China social media and creating a significant
affecting sales and profitability due changes in the industry model.
to tightened healthcare budget by
• Risk of exclusive investments in
research and development (R&D) for
• Delay in commercialization of new products or extension on
product due to challenges including existing product , beyond the growth
technological innovation, clinical of sales. • Outsourcing risk with increasing
trials, regulatory approvals, reliance on third parties for key
• Expanding international operations
encountering infringement claims business functions such as clinical
leading to risks due to non-
and feasibility. trials, manufacturing, sales and
compliance with various regulations,
• Biotech drugs are gaining traction economical and political
and increasing competitive pressure developments, discriminatory fiscal • Risks associated with product
on traditional business model based policies etc. liability, and recalls, resulting in
on chemical drug. legal proceeding and tarnishing
brand name.
• Inability to recover and sustain
critical operations following a
disruption in the production and
manufacturing facility.
• IT risks relating to increased • Heavy reliance on the performance
dependence on information of certain flagship products.
technologies and networks in • The risk of adverse movements in
research and development, interest rates, exchange rates and
production and sales,. stock prices..

• Rising pressures from

environmental activists due to
increasing speculations of
pharmaceutical residues leading to
contamination of water and soil.
• Failure to protect patient's
• Claims and investigations relating to
interests and maintain the integrity
competition law, marketing
of human clinical trial research..
practices, pricing, compliance,
• Risk to reputation/brand as a result antitrust, environmental,
of negative assessment or employment and tax litigations.
comments from stakeholders.
• Risk of securing and protecting
intellectual property rights from third
parties who can launch generic
versions of company's products or
impose infringement allegations.
• Increasing pressure on prices due to
government price controls.
• Increasing healthcare regulatory Internal Audit, Risk & Compliance
Emerging Risk requirements for clinical trials and Services
Existing Risk launch of products. Practice leader for Europe, Middle-
East & Africa (EMA)
Retiring Risk • Fraud, violations of the laws
T +27 (0)82 719 2392
tariff/policies and cross-border
E ashley.smith@kpmg.co.za