Pharmaceutical Law and Policy – Hot Topics Shaping the Future of the European Pharmaceutical Industry

This course provides a broad and practical understanding of the ‘hot topics’ and will present and analyse these topics from scientific, legal and policy perspectives. These hot topics include:

• Scientific trends – Scientific breakthroughs that impact the pharmaceutical industry and create new business opportunities.


• Biosimilars & antibodies – How do we navigate the new approval pathways and regulatory requirements in Europe and the US regarding biosimilars and antibodies? What are the practical implications, risks and opportunities?


• Data & market exclusivities – How much protection is provided by the current legal framework? Does the present system provide enough incentives for biologics, orphan drugs and new uses, or are the currently available data and market exclusivities overly protective, too anti-competitive and/or too expensive?


• Personalized medicine and telemedicine – The possibility of personalized medicine and telemedicine is a dream come true for many patient groups, but what are the downsides from scientific, legal and policy perspectives?


• New markets – How to address risks, challenges and opportunities concerning the emerging Asian markets? Is the EU regulatory regime for clinical trials detrimental to EU competitiveness compared to the US and Asia? Are there improved methods that do not compromise safety, efficacy and individual rights? And can the EU find solutions to cut time and costs in getting new medicines on the market?


• Clinical trials – New challenges posed by increasing international competition.


• Patents & competition law – Recent pharma-related case law and legislative developments concerning research exemptions and patents. Special emphasis will be laid on the patentability of stem cell technology, protein- and DNA-related innovations, second and further medical uses, dosage regimes and diagnostic methods. Moreover, the interface between IPRs and competition law will be highlighted with a focus on switching, product-hopping, patent misuse, patent settlements and compulsory licensing.


• Paediatric extensions & SPCs – will be discussed through current political debates and case law.


• Public-Private Partnerships (PPPs) – An increasingly important model of co-operation. Where could they help? How can we facilitate co-operation?


• Counterfeit Medicines – Globalisation and the Internet have increased the risks of counterfeit drugs endangering human life and presenting a severe threat to the pharmaceutical industry and public trust in pharmaceuticals. We will present the scientific, legal and social scales of this dilemma and discuss various policies for tackling the problems.