Pharmaceutical Law and Policy
- Hot Topics shaping the Future of the European Pharmaceutical Industry
What are the most significant current issues shaking and shaping today's pharmaceutical industry? The business environment and legal framework pertaining to the pharmaceutical industry continue to change rapidly as they are constantly challenged by competition, politics and new technological possibilities. Considering the highly lucrative and competitive nature of the industry, it is more important than ever for professionals working with legal and regulatory aspects of drug development to stay abreast of the most recent developments.
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. The hot topics are:
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Scientific trends - Scientific breakthroughs that impact the pharmaceutical industry and create new business opportunities
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Biosimilars & Antibodies - New approval pathways, guidelines & regulatory requirements
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Data & market exclusivities - Legislation and political debates
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Individualized medicine - Threats, challenges and opportunities
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New markets - How to deal with the emerging Asian markets?
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Clinical trials - New challenges posed by increasing international competition
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Patents & competition law - Recent pharma-related case law
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Paediatric extensions & SPCs - New developments & case law
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Public Private Partnerships (PPPs) - An increasingly important model of co-operation
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Counterfeit Medicines - Buying and selling pharmaceuticals in cyberspace beyond established quality control systems?
What you will learn
After the course, you will have strengthened your capacity to deal with the crucial issues of today and tomorrow, i.e. you will:
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Better understand current EU debates concerning pharmaceuticals and analyze the effect of drug policy decisions
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Understand new trends and developments that are particularly important for the pharma sector
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Better understand crucial issues in EU Patent & Competition Law and compare them with US Law
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Raise your awareness of the challenges posed by emerging markets, such as China and India
- Better be able to navigate new approval pathways for biosimilars, as well as conduct risk-benefit analysis to identify the true commercial and clinical value of a biosimilars
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Give advice on data exclusivity, SPC regulation and trade secrets
Course content
The course starts out with an overview of the current overall trends in R&D, organisation and policy, followed by a review of the hot topics through a mix of lectures, discussions, group work and case studies. The hot topics are examined by addressing the following crucial questions that determine the future of the European Pharmaceutical Industry:
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? Can we substitute? Should we substitute?
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 or too expensive?
The possibility of individualized medicine is a dream come true for many patient groups, but what are the downsides from a scientific, legal and policy perspective?
How do we address risks, challenges and opportunities concerning the emerging Asian markets? Is EU bureaucracy detrimental to EU competitiveness in the pharmaceutical industry when it comes to clinical trials compared to the US and Asia? Are there improved methods that do not compromise safety, efficacy and individual rights? And is it possible to find an EU solution that will cut time and costs in getting new medicines on the market?
What are the recent pharma-related case law developments concerning basic patentability requirements and competition law? Here special emphasis will be placed on the patentability of selection inventions, stem cells, protein & DNA-related inventions, second & further medical uses, dosage regimes and diagnostic methods. The competition issues will be highlighted by the developments and legislative proposals with a focus on switching, product hopping, patent misuse and patent litigation settlements.
It is possible to buy and sell counterfeit medicines in cyberspace thus circumventing established quality control systems - what are the scientific, legal and policy implications of this growing practice? Also paediatric extensions & SPCs will be discussed through current political debates and case law.
Finally, we will discuss Public Private Partnerships (PPP). Where could they help? How can we facilitate co-operation?
Participants
The course is designed for professionals working in the field of legal issues and/or regulatory aspects of drug development, decision-makers, administrators and health care practitioners within both the public and private sector, e.g.:
- Legal departments in the Pharmaceutical Industry
- Law firms dealing with patent and competition law in the pharmaceutical industry
- Branch organizations in the pharmaceutical sector
- Health care professionals and decision makers
- Bank and Finance consultants working with risk and investment in the pharmaceutical industry
Credit - especially for lawyers and trainee solicitors
This summer course addresses professionals and covers a broad variety of legal issues that are of particular relevance to the pharmaceutical sector. It thus meets the requirements for compulsory supplementary training for lawyers and trainee solicitors, cf. section 3 in BEK no. 1474 0f 12/12/2007 and no. 820 of 25/06/2010. Depending on attendance the course will give a maximum of 40 hours of credit. Please note that Advokatsamfundet does not issue approvals of planned or conducted supplementary training activities - neither for providers, lawyers or trainee solicitors. Therefore, the University of Copenhagen cannot guarantee that such an approval will take place in any spot test.
Course dates
5 days, 13 - 17 August 2012, 9.00 - 17.00 at the University of Copenhagen, Frederiksberg Campus.
Course director
Timo Minssen, Assistant Professor, LL.M., MI.L., Centre for Information and Innovation Law, Faculty of Law, University of Copenhagen.
Other course teachers
Peter Ganea, Dr., Programme Coordinator of Modern East Asian Studies at Goethe University, Frankfurt, Søren Christian Søborg Andersen , Attorney, Horten Law Firm, Sven Frøkjær, Professor, Vice-dean, Faculty of Health and Medical Science, University of Copenhagen, Janine Traulsen, Associated Professor, PhD, Department of Pharmacology and Pharmacotherapy, University of Copenhagen, Jacob Bjerg Larsen, Chief Advisor, The Danish Association of the Pharmaceutical Industry(LiF), Jens Schovsbo, Professor, Centre for Information and Innovation Law, University of Copenhagen, Lars Conrad Sparre, European Patent Attorney, Lundbeck A/S, Jesper Thorsen, European Patent Attorney, Inspicos A/S, Henrik Bendiksen, European Patent Attorney and Director of IPR, Symphogen A/S.
Course fee
DKK 18,500/EUR 2,500 (excl. Danish VAT 25%). Fee includes teaching, course materials and all meals during the course.
