Corporate Counsel Q&A

The BPI is the industry association for Germany’s pharmaceutical sector, consisting of over 260 firms which range from small and medium-sized enterprises to multinational companies. These include traditional pharmaceutical firms and service-providers as well as biotechnology and medical device companies, who all look to the BPI as a platform for information and communication, to develop unified responses to the diverse challenges they face in the industry.

The association has over 60 years’ experience in issues related to the development, authorisation and marketing of medical products and represents the full spectrum of its members’ activities at both national and international levels. The BPI implements modern organisational structures on the domestic and European stage, and has established political, economic and scientific networks, enabling it to work with with key policymakers at all levels.

The BPI’s success is also built on the development of specialised committees and departments with experts and member representatives, allowing member companies to exchange professional information and engage directly in the association’s activities. Who’s Who Legal spoke with Matthias Heck, attorney-at-law and head of the BPI’s Brussels office, about his role within the BPI, recent projects, the current state of the pharmaceutical sector and the association’s interaction with the legal industry.

Tell us about your role at BPI

As head of the Brussels office of BPI, my responsibilities regard developments on the EU level influencing our member companies. Next to the ongoing legislative procedures conducted by the European Commission, the European Parliament and the Council, such topics can include more specific measures such as infringement procedures initiated by the Commission, developments at the European Medicines Agency or decisions by the European courts.

Tell us about any recent special projects your team has been working on? Which law firms did you hire?

The recent inquiry by the Commission relating to an alleged breach of EU state aid law is a current example. This procedure illustrates how decisions taken on the EU level (infringement procedure) directly influence spheres that are generally perceived as being entirely in the national competence (reimbursement). The procedure concerns the German provision for exceptions from the mandatory discount which pharmaceutical companies have to give to the statutory health insurers. In this case we are working with WilmerHale.

What criteria do you use when deciding which firms or lawyers to instruct in relation to a pharmaceuticals legal issue?

As in other sectors, a proven track record and expertise are key. Since the pharmaceutical sector is among the most highly regulated industry sectors it is necessary that firms and lawyers bring an understanding of the specifics of the sector to the table.

In the pharmaceutical industry, is the legal marketplace very competitive? Is there a lot of choice for clients such as yourself? How can firms distinguish themselves?

Increasingly, large firms establish and strengthen their life sciences practices. At the same time, specialised boutique law firms enjoy a high degree of credit. A lot comes down to personal, specific knowledge of the sector: by making the right choices when putting together their teams, firms can get recognition. Furthermore, establishing contact is important – for example being active in the (legal) committees of relevant associations allows for visibility with the companies and, as such, potential clients.

What is the greatest challenge – legal, practical or political – facing the pharmaceutical industry in Germany?

A key aspect is certainly the pricing and reimbursement environment in Germany. At the beginning of this year, the price freeze (which was due to end on 31 December 2013) was continued – at the price level of 2009. The implications for companies faced by increased costs of labour, energy and supplies, and not least inflationary pressures are obvious. At the same time the early benefit assessment still leaves room for improvement. Given the high number of countries referencing to German prices, this situation goes beyond the borders of Germany and indeed the EU.

What makes a good private practice lawyer?

Next to knowledge and experience it is a certain entrepreneurial approach; by this I mean proactively thinking which aspects might become relevant for (potential) clients and the ability to link developments from different areas.

What do you consider to be your most important role at BPI?

The position involves working in two directions. On the one hand, identifying how the legislation at EU level might influence our member companies in Germany and trying to ensure that such aspects are adressed in the process; on the other, looking towards Brussels from the German perspective and trying to identify ways where the EU level might provide solutions for challenges originating from Germany (or other national markets where our members are active).

Are there any recent regulatory changes or cases in the sector that have caught your attention?

Certainly the cases relating to which data from clinical studies are to be considered commercially confidential are of crucial importance. Here two companies have taken legal measures against the disclosure of such data by the European Medicines Agency to competitors. In one of the cases, our European umbrella association EUCOPE, where I used to serve as legal counsel, is an interested party.

How do you see the industry developing in the next five years? Are there any technological advances that might have an effect on the way the pharmaceutical sector operates?

Looking at recent advances the role of biotech companies is certainly on the rise. In terms of technological advances the announcement of increasingly cheaper gene analysis possibilities could lead to further developments in this space. At the same time I am convinced that niche activities, including research on known substances, will remain an important factor especially for medium-sized companies.