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6 December 2018Big Pharma

European pharma body criticises SPC waiver vote

The European Federation of Pharmaceutical Industries and Associations ( EFPIA) has sharply criticised an opinion on supplementary protection certificate (SPC) proposals that was issued by a European Parliament committee.

On Monday, December 3, the European Parliament Committee on International Trade voted in favour of a draft opinion it had published last month. The opinion suggested over 100 amendments to the European Commission’s proposal for a SPC manufacturing waiver, but expressed support for the plan.

The proposed waiver would allow generic versions of SPC-protected drugs to be produced during the term of their certificate, provided they are distributed exclusively to non-EU markets where protection has expired or never existed.

The Commission proposed the waiver, in May, with the aim of supporting “Europe's pioneering role in pharmaceutical research and development”.

Last month, the Committee on the Environment, Public Health and Food Safety submitted amendments to the waiver, including a “day one” possibility, which allows for the stockpiling of generic medicines which can be launched after the innovator drug’s patent expires.

The Trade Committee echoed the position previously put forward by the Health Committee, also calling for a “day one” amendment.

Both the Trade and Health Committees can submit opinions on the matter, but responsibility for producing a report to the Parliament rests with the Committee on Legal Affairs.

The Committee on Industry, Research and Energy declined to offer an opinion.

In a statement published on Tuesday, December 4, EFPIA said the Trade Committee’s opinion “does not provide appropriate safeguards” for IP holders and “risks further disincentivising investment” in the European pharmaceutical industry.

The statement warned that if implemented, the proposals could endanger economic growth and patient access to important medicines in Europe. EFPIA is concerned that the proposals favoured by the Trade Committee will erode the IP rights of innovators who produce original pharmaceutical drugs.

Medicines For Europe (MFE), which represents companies marketing generic and biosimilar drugs in Europe, welcomed the Trade Committee’s decision. In a statement, MFE said the Committee’s proposals have the potential for “huge industrial job opportunities and healthcare savings as SPCs expire on blockbuster medicines” over the coming years.

Adrian van den Hoven, director general of MFE, thanked the Trade Committee for “not caving in to vested interests and foreign pressure by voting for a comprehensive SPC manufacturing waiver”, and urged the Committee on Legal Affairs “to adopt a final report that will strengthen Europe’s ecosystem for pharmaceutical manufacturing”.

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