The UK House Of Commons-Style Debate

DOUBTS ABOUT REGULATION

After having called for some calm and restraint, the moderator opened discussion on the third motion, ‘EU Regulation ultimately benefits small and medium-sized biotech companies’. Arguing for the motion was Julien Mousnier, policy co-ordinator for biotechnology at the European Commission. According to Mousnier, EU regulation is helpful for any company, but particularly small and medium-sized biotech companies, because it delivers predictable and harmonised rules for 450 million citizens in 27 member states, creating a level playing field in the world’s biggest single market. What’s more, he said, small and medium-sized enterprises have access to development subsidies based on EU regulation.

Other proponents of the motion added that small and medium-sized biotech companies do not need to serve all 27 markets in order to reap the benefits of EU regulation. They already benefit by picking and choosing those markets that suit them particularly well. “EU regulation and central market approval procedures offers them fantastic opportunities,” one participant said.

Most participants of the debate, however, thought differently. Their prime spokesman was Andreas Emmendörffer, CEO of Leipzig, Germany-based Euroderm, a tissue engineering company.

In the real world, Emmendörffer said, EU regulation plays into the hands of large companies because only they can afford the staff needed to deal with it. Small companies are not interested in servicing 27 member states, he said, just one or two, yet they have to meet complex EU rules and produce documents in many languages. His own company, for instance, has to file registration dossiers on its advanced medicinal product to the European Medicines Agency in London, although it plans to sell just to clients in Germany. And even when it will be approved EU-wide, he said, the company will still have to go through 27 member states to secure reimbursement under as many health system regulations.

Other participants also weighed in saying EU regulation, such as REACH, is too complicated and therefore ultimately benefits big companies, not small ones. EU directives do more harm then EU Regulation, another participant said, by leaving member states wiggle room for not implementing them correctly or consistently, in effect thwarting the emergence of a real single market. “EU regulations create many jobs, not for biotech companies but for lawyers and bureaucrats,” it was added. 

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