Extension of export waivers on EU generics and biosimilars  

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Rules on supplementary protection certificates, aimed at boosting competitiveness of EU-based biosimilar and generics companies, were approved by MEPs on Wednesday.

On Wednesday, MEPs approved amended rules, provisionally agreed with EU ministers, which aim to increase exports of EU generic and biosimilar medicines to third countries. The Regulation introduces an exception for manufacturing waivers, more specifically in the area of protection granted by a supplementary protection certificates (SPCs). The new rules also include safeguards guaranteeing the protection of intellectual property in the EU and increase transparency.

The exceptions will apply where:

  • Generic or biosimilar medicines are produced exclusively for export to third countries during the SPC period; it is possible to stockpile the product for the last 6 months of the SPC period, thus allowing day-1 launch on the EU market after the basic supplementary protection expires;

  • The maker has to notify competent authorities and certificate holders before the start of production (at least three months in advance);

  • The maker has a labelling obligation for EU export products, e.g. logos, guaranteeing the product is not diverted towards the EU market;

  • The maker is required to inform persons in its supply chain that the product is covered by the exception and is intended for the purpose of export and/or EU day-1 entry.

These exceptions will reaffirm the attractiveness of the EU as a global hub for investments in innovative pharmaceutical research, while at the same time rules will lower costs and improve access to generics and biosimilar medicines inside the EU, believe MEPs.

“A consensus finally reached has managed to reconcile two legitimate interests in collision. The value of the innovators’ activity creating thousands of new medicines and active ingredients each year justifies the system of intellectual property incentives. Moreover, the fact that European generic manufacturers who could not compete successfully with those from third countries that operate without limitations work now in equal conditions. The regulation entails great benefits for the industry, increasing jobs and pharmaceutical savings” added rapporteur Luis de Grandes Pascual (EPP, ES)

Next steps

Plenary endorsed the agreement with 572 votes to 36, with 22 abstentions. The Regulation still requires a formal adoption from EU ministers, before it is published in the EU Official Journal and enters into force.