SPCs are intellectual property rights that extend patent protection (up to five years) for medicinal products that must undergo lengthy testing and clinical trials before being authorized to be placed on the market in the European Union (EU).

However, such protection also prevents European companies from exporting to countries where patents have expired. The European Commission therefore published draft guidance proposing an ‘export manufacturing waiver’ to SPCs to allow EU-based companies to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the certificate, if done exclusively for the purpose of exporting to a non-EU market where protection has expired or never existed [1].

On 23 January 2019, the Legal Committee of the European Parliament (JURI), which combines the opinions of the Environment, Public Health and Food Safety (ENVI) and International Trade (INTA) committees, voted in support of a comprehensive SPC manufacturing waiver.

The compromise agreement by the JURI Committee includes the possibility to produce generic and biosimilar medicines during the SPC period for export purposes and to stockpile for two years to prepare for launch in the EU on day-1 after SPC expiry. The JURI Committee also voted to implement the SPC manufacturing waiver starting in January 2021.

The vote by the JURI Committee was welcomed by Medicines for Europe, which represents generics and biosimilars makers. Director General, Adrian van den Hoven, commented that ‘The Parliament has made a thorough review and introduced many positive changes to the SPC manufacturing waiver proposal. With some further fine-tuning of this text in the trialogue phase, the SPC manufacturing waiver will deliver on its promise for patient access, for pharmaceutical manufacturing jobs, and for sustainable healthcare budgets in Europe.’

However, in contrast, The European Federation of the Pharmaceutical Industries and Associations (EFPIA) which represents 40 of the biggest investors in life science research and development, said that the JURI decision ‘puts the future of medical innovation and access to the latest treatments for patients in Europe at risk’. The EFPIA had previously asked for assurances that makers of generics and biosimilars would not be manufactured within Europe to be stockpiled awaiting expiration of intellectual property or SPC rights. The group also pointed to a recent study, which found that implementation of an EU-wide SPC manufacturing and export exemption would potentially result in annual losses ranging between Euros 2.36 billion and up to Euros 4.71 billion to the global innovative biopharmaceutical industry, with approximately Euros 1.18 billion to Euros 2 billion of these attributed to the European innovative biopharmaceutical industry.

The next step is for the mandate to be approved in the European Parliament.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. EC proposes waiver of SPCs to allow manufacturing of generics and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 1]. Available from: www.gabionline.net/Policies-Legislation/EC-proposes-waiver-of-SPCs-to-allow-manufacturing-of-generics-and-biosimilars

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