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04 Jun 2018

The EU Export Manufacturing Waiver: A boost for the Generic and Biosimilar Medicines Market?


On 28 May the European Commission adopted a legislative proposal for a regulation to amend Regulation (EC) No. 469/2009 on Supplementary Protection Certificates (SPCs) for medicinal products.

The initiative proposes to introduce an 'export manufacturing waiver' (''EMV''). This would allow EU based companies to manufacture certain generic and biosimilar versions of an SPC protected medicine during the term of the SPC if done exclusively for the purpose of exporting to a non-EU market where IP protection has expired or never existed. Presently in Europe the manufacture of generic and biosimilar products is not permitted whilst patent or SPC rights in the country of manufacture are in place, whether the product even if the product is for export to non-EU IP-free territories. The reforms will not apply to existing SPC's or pending applications and if enacted would be subject to review after five years.

SPCs are an intellectual property (IP) right provided for by EU regulations for pharmaceutical and plant products and serve as an extension to a patent right for up to a maximum of five years (with an additional six months extension in accordance with Regulation (EC) No. 1901/2006 if the SPC relates to a medicinal product for children for which data has been submitted according to a Paediatric Investigation Pan (PIP)). One of the primary aims of an SPC is to offset the effectively shortened period of patent protection for pharmaceutical and plant products that may occur due to the time between filing the patent and the product coming to market. This delay is caused by the lengthy compulsory testing and clinical trials these products require prior to obtaining regulatory marketing approval.

The EMV initiative was first considered by the EU Commission following the adoption of the Single Market Strategy Report of 2015 with a view to promoting EU investment growth and has been supported by a series of impact assessment studies and public consultations in an effort to recalibrate certain aspects of patent and SPC protection. The proposal contains a number of safeguards which seek to create transparency and prevent IP infringing products from entering member state markets. However, some of the unintended effects of the proposed EMV initiative, such as the production for 'day 1 launch' in Europe of products after the expiry of the SPC have not been fully addressed (although some say that the EMV can be viewed as a natural extension of the current Bolar exemption).

Whilst generic and biosimilar medicines manufacturers will welcome the proposed legislation with its efforts to boost market competitiveness, the European Federation of Pharmaceutical Industries (EFPIA) has stated that the Commission's proposal to grant an SPC manufacturing waiver will reduce the IP rights of industry by destabilising the IP incentives system which was initially introduced to attract and drive research in Europe and allow greater access by patients to innovative medicines.

The Commission will next require approval from the European Parliament and the Council of Minsters before the proposal takes legislative effect.



Alexandra Pygall

Alexandra Pygall

T:  +44 20 7809 2137 M:  +44 7881 314 566 Email Alexandra | Vcard Office:  London

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