OR WAIT null SECS
The European Commission’s new structure has sparked controversy about its allocation of responsibilities and the impact on the development and approval of new medicines.
The year 2015 will be a testing time in the area of pharmaceuticals and related products such as medical devices for the new European Commission, which took over in November under the presidency of former Luxembourg prime minister, Jean-Claude Juncker. The performance of the Commission will be closely scrutinized during the year by the pharmaceutical industry, healthcare non-governmental organizations (NGOs), and members of the European Parliament (MEPs).
The industry will be watching carefully to ensure that the Commission, in the first of its five-year term, adheres to its declared objective of helping to create a more innovative and internationally competitive European pharmaceutical sector, while improving the efficiency of the European Union internal market in medicines. In particular, it will be hoping that the Commission will make progress in resolving the key issue of how much improved health, with the help of pharmaceuticals and other treatments, can help to stimulate economic growth at a time when many EU economies are struggling to bolster job creation and industrial output. NGOs, organizations representing healthcare professionals and MEPs will, on the other hand, be attentive to the Commission’s pledge to give priority in pharmaceutical matters to public health.
Responsibilities of commissioners
Controversy about the incoming Commission’s strategy with pharmaceuticals and to a lesser extent, medical devices, has been raging since Juncker proposed in the summer that Elzbieta Bienkowska, the Polish new Commissioner for the directorate-general (DG) or department for the internal market, industry, entrepreneurship, and small and medium-sized enterprises (SMEs), would have responsibility for all pharmaceutical issues including the operations of the European Medicines Agency (EMA), the EU’s London-based central licensing agency for medicines. This meant that Vytenis Andriukaitis, the Lithuanian new Commissioner for DG health and food safety, would, unlike his predecessor, not be in charge of pharmaceutical regulations, including the marketing authorization of medicines.
The proposals immediately met fierce opposition from the healthcare community, many politicians, and even health ministers in the EU’s 28 member states on the grounds that the interests of manufacturers were being put before those of patients. The prestigious United Kingdom medical publication, British Medical Journal (BMJ), claimed that the change, if it went ahead, would represent a “victory for profits over public health” (1).
Faced with the possibility that the European Parliament might not approve the new Commission, Juncker backed down, acknowledging to MEPs that “medicines are not goods like any other.” While returning the responsibility for pharmaceutical regulation back to the DG where it had resided since 2009, Juncker decided to keep medical devices under the charge of Commissioner Bienkowska. He also stipulated that policies on pharmaceuticals and medical technologies such as devices would be drawn up jointly by Commissioners Bienkowska and Andriukaitis. This move has triggered criticism that within the new Commission no one has been allocated clear leadership on pharmaceutical matters.
Orphan drugs, advanced therapies, and personalized medicines
Meanwhile, the organizations representing various sections of the pharmaceutical industry are hoping that after the dust from the fight over the allocation of responsibilities has settled, the Commission will be effective in taking action on key issues. This is particularly the case with innovations in areas like orphan medicines, advanced therapy medicinal products (ATMP), and personalized medicines, with which the Commission is seen as having an influential role to play in Europe.
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), which mainly represents SMEs, wants the Commission to do more to harmonize the ways orphan medicines are assessed for use in the healthcare services of EU countries. “Despite the benefits of [the EU orphan medicine regulation], major inequalities in patient access to them still subsists between the member states,” Oliver Sude, EUCOPE’s legal counsel for EU affairs told BioPharm International.
“The availability of harmonized value assessment of orphan medicines based on a common definitions [of aspects like quality, safety, and efficacy] will be very useful for SMEs who don’t have the resources to fund large regulatory affairs departments,” he continued. “It is something that the previous Commission started tackling and despite the restructuring of the new one, we expect it to be able to carry on with this work.”
The European Association of Bio-industries (EuropaBio), a major trade association for biotech companies, wants the new Commission to give precedence to raising awareness of the benefits of personalized medicines and to help SMEs navigate their way through the regulations on the products. “Personalized medicines are not only dealing with unmet health needs but also is a field that stimulates investment in innovation, develops high-level skills, and has a positive impact on academia and second- and tertiary-care institutions,” said Miriam Gargesi, EuropaBio’s healthcare director.
Pharmaceutical companies hope to benefit from the Commission’s continued work on the EU Better Regulation program, although it seems to be giving precedence initially to the effectiveness of regulations on the environment and waste.
Supplementary protection certificates
EU-based producers of generic medicines want a relaxation of the regulation on supplementary protection certificates (SPCs) extending the lifetime of patents on original drugs by up to five years. They want to be able to export during the SPC period to third countries where no patent or protection certificate is in place. “Introducing an export exception in the SPC regulation will allow the European generic and biosimilar medicine industries to produce more high quality medicines in Europe for export to the rest of the world,” Adrian van den Hoven, director-general of the European Generic Medicines Association (EGA), told BioPharm International. “An SPC export exception would insource dozens of thousands of high-technology jobs, R&D, manufacturing science, and know-how, while stimulating the global competitiveness of the European generic and biosimilar medicines industries.”
EGA wants the Commission to use its system of setting annual economic targets, including, if necessary, healthcare indicators, to bolster sales of generic drugs. The system, called the European Semester, aims to help the EU meet its Europe 2020 targets for economic growth and recovery. One Europe 2020 target is to raise industry’s share of EU gross domestic products (GDP) from a current 16% to 20% by the end of the decade.
“We support the inclusion of clearer EU Semester recommendations on uptake of generic and biosimilar medicines in relation to the 17 member state reports [under the Semester system] that include healthcare reform measures,” said van den Hoven. “Our data show that uptake measures [for generics] that stimulate more competition in pharmaceutical markets provide much higher overall savings and better health outcomes for patients than short-term cost containment measures.“
EGA has been advocating to EU officials initiatives that both improve healthcare systems and make the European generic-drug industry globally competitive. “We have been clear from the beginning that we want coherence in the EU’s pharmaceutical policy,” van den Hoven said. “Commissioners Bienkowska and Andriukaitis have all the policy tools in hand-health policy, pharmaceutical policy, industrial policy-to deliver over the next five years.”
The role of healthcare in EU economics
European Federation of Pharmaceutical Industries and Associations (EFPIA), representing research-based companies, has stressed to policy makers the importance of healthcare to a thriving economy. “The economic crisis in Europe at times has led to sometimes drastic steps to be taken on healthcare that have not only affected patients, but have also raised questions about how we see healthcare as a driver of Europe’s future prosperity,” explained Richard Bergstroem, EFPIA director general, to BioPharm International. “Health should be seen as a key enabler of a productive economy in Europe,” he added. “Additionally, the pharmaceutical industry adds value to the EU not only in terms of health, but also through exports and economic activity, such as employment of skilled people.”
Like most other European trade associations in pharmaceuticals and related products, EFPIA is optimistic about the new Commission, particularly about its objective of overcoming what Juncker calls “silo mentalities” through greater collaboration and collegiality in the Commission itself. “His efforts to support coordination across the Commission is a positive step,” said Bergstroem. “His programme offers a compelling vision for the future and a renewed call for partnership between EU institutions and member states.”
An achievement for the new Commission this year will be to convince at least some of the leading sceptics in the healthcare community that a strong pharmaceuticals sector will not only help boost the health of Europe’s population but also help revive Europe’s ailing economy.
1. M. McKee and P. Belcher, “The European Commission and pharmaceutical policy” BMJ. Accessed Sept. 15, 2014.
About the author
Sean Milmo is a freelance writer based in Essex, UK, email@example.com.
Article DetailsBioPharm International
Vol. 28, Issue 1
Citation: When referring to this article, please cite as S. Milmo, “Great Expectations from New European Commission,” BioPharm International 28 (1) 2015.