Industry in conflict over generic and biosimilar manufacturing waiver
The European Commission (EC) published draft guidance suggesting that it could provide an exception to the supplementary protection certificate (SPC) for the benefit of the generic and biosimilars industry.
The SPC provides those holding intellectual property (IP) on a medicinal product to claim additional protection of five years to forestall European manufacturers from producing generic or biosimilar versions.
However, the EC concluded in its draft guidance: “markets have evolved significantly and there has been huge growth in the manufacture of generics and especially of biosimilars, in particular in countries outside the EU where protection does not exist or has expired.”
Under the draft guidance manufacturers based outside of the European Union (EU) are able to manufacture and distribute products in countries where such IP protections are not present – while those based in Europe are not able to manufacture or export to countries outside of the EU.
“The viability of makers of generics and biosimilars established in the [EU] could be under threat,” the EC concluded.
As a result, it has decided to amend the regulation to allow for such manufacturers to produce the products within the five year period to allow them to export to ‘third country markets’.
Support and opposition
A pitched battle is underway within the European pharmaceutical industry, as generic and biosimilar producers welcomed the draft regulation and the wider industry criticised the move.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) released a statement critical of the move: “The draft regulation undoubtedly sends a signal to the world that Europe is weakening its commitment to IP incentives and innovation, Member States’ current support of the original scope of the Commission’s proposal could go some way to prevent further erosion of Europe’s IP framework as a consequence of its implementation and must be maintained.”
The EFPIA also called for guarantees that generic and biosimilar medicine would not be manufactured within Europe to be stockpiled awaiting the lapse of originator products’ IP protection.
Conversely, Adrian van den Hoven, director general of Medicines for Europe, praised the EC for “not caving in to vested interests and foreign pressure” by tabling the regulation.
He continued, “The manufacturing waiver is the first step in a policy to ensure Europe’s security of supply of medicines, to stop the delocalisation of production and to stimulate competition after SPC expiry.”
Medicines for Europe has predicted that the EC’s potential measures would lead to increased job opportunities and for savings to be made across healthcare systems in the region.
The next step will be for the mandate to be negotiated within the European Parliament.
Vote provides further controversy
On January 23, Legal Committee of the European Parliament (JURI) combined the opinion of the Health and Trade committees to vote in favour of the SPC waiver, whilst also recommending amendments.
The judgement included the allowance of generic and biosimilars companies to build a two-year stockpile of medicines prior to SPC expiry.
The JURI committee also recommended that the starting date for this regulation should be January 2021.
Medicines for Europe welcomed the vote, with Hoven commenting: “The Parliament has made a thorough review and introduced many positive changes to the SPC manufacturing waiver proposal."
However, the EFPIA concluded that the proposed changes would be detrimental on a number fronts: "If adopted in the final text, the amendments will impact European patients living with unmet medical needs, they will significantly weaken Europe’s research and development offering, as well as drive away investment and jobs from our SMEs, our companies, our academic institutions and our healthcare systems."