Under the Microscope

'Under the Microscope' takes a look back at some of the key legal developments in the Lifesciences sector in 2014 across Europe, including:

• Regulatory/Competition
• Compliance/Transparency
• Intellectual Property
• Product Liability

We also consider the impact of these developments for the sector this year, particularly the opportunities and trends for you and your business.

The challenging European austerity market has continued throughout 2014 with increased member state focus on prices even to the point where this threatens to overturn the EU regulatory framework for products like medicines. CMS in Italy and France report on the actions taken by the competition authorities and legislators to relax the legal restrictions on supply and use of off-label or unauthorised medicines on purely economic grounds in their countries. At an EU level the Commission issued its 5th patent settlement report in December 2014 against a backdrop of continuing enforcement action against reverse payment settlements. Companies with strong market presence in narrowly deined markets will also have to be mindful of the European General Court’s June decision against Intel (concerning the anti-competitive nature of exclusivity rebates) when developing commercial strategy.

Although the medical and diagnostics devices sector continued its wait throughout 2014 for the completion of the EU revision of the sectoral legislation, the publication of the EU Clinical Trials Regulation in May 2014 means pharmaceutical companies should start preparing early for the new regime which will introduce signiicant changes to administrative procedures and liability exposure and also the data transparency framework, which has also been changed by the EMA’s policy on publication of clinical data released in October 2014.

2014 also saw some highly signiicant developments for compliance. Germany’s supreme court relaxed the prohibition on gifts to health professionals in some circumstances while the pharmaceutical industry tightened its own rules and also geared up for EFPIA transparency. Meanwhile in the medical devices sector MedTech Europe adopted a different approach and started planning for a switch away from directly sponsoring health professionals at medical congresses by 2018. Switzerland, however, finished 2014 with no less than three different drafts of the revised Therapeutics Products Act to change the law on discounts and incentives for pharmacists and health professionals for pharmaceutical, and possibly also medical device companies.

A number of Intellectual Property developments occurred in 2014 which could positively impact European businesses in the future. We report on further progress made towards the EU Unitary Patent and Unified Patent Court, paving the way towards a harmonised patent system in Europe. We also highlight a key decision from the European General Court which provides much needed clarity on the IP protection available for stem cell researchers, and CMS Germany highlight an important German Court decision which promises to provide extended opportunities for those seeking patent protection via second medical use claims.

While we all await the outcome of the latest round of TTIP negotiations between Europe and the United States on regulatory compatibility and sectoral regulatory co-operation and the new opportunities for pharmaceuticals and medical devices which these are promised to bring, we hope you find our selection and collected analyses a helpful guide for Lifescience businesses during 2015.