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SPC manufacturing waiver
article 15 Jul 2019

The SPC manufacturing waiver

On 1 July 2019 Regulation (EU) 2019/933 (‘the Regulation’), introducing the so-called SPC manufacturing waiver, entered into force across the European Union. The SPC manufacturing waiver is an amendment to existing legislation concerning supplementary protection certificates (SPCs) with the primary objective of facilitating the generic industry (within the EU) by allowing them to manufacture SPC protected medicinal products for the purposes of (i) export and/or (ii) preparing for European ‘day-one launch’, from 6 months before expiry of the SPC.

In this article we take a brief look at the purpose and history of the Regulation, followed by a summary of the exempted acts and the scope of the Regulation, finally concluding with some practical considerations.

 

Purpose and history

The considerations included in the Regulation shed some light on the underlying purpose and history of the Regulation and the amendments it introduces into the existing SPC system.

Since the inception of the SPC regime in 1992, markets have evolved significantly and there has been huge growth in the manufacture of generics and especially of biosimilars, and in the manufacture of their active ingredients, in particular in countries outside the EU in which SPC protection does not exist or has expired.

According to the legislator, those circumstances put makers of generics and biosimilars established in the EU at a significant competitive disadvantage in comparison with makers based in other countries that offer less or no protection. Diminishing generic investments, hampering job creation, reduced competition, increased prices and reduced access to affordable medicines are further mentioned as risks in the scenario that the SPC regime were not to be amended.

With this Regulation, the EU attempts to strike a balance between restoring a level playing field for generic drug makers and ensuring that the essence of the exclusive rights of SPC holders is guaranteed in relation to the EU market.

The fundamental aim of this Regulation is to promote the competitiveness of the EU, by allowing makers of generics and biosimilars established in the EU to make in the EU products (active pharmaceutical ingredients), or medicinal products containing those products, for the purpose of export to third-country markets in which protection does not exist or has expired, thereby also helping those makers to compete effectively in those third- country markets. The EU exemption of day-one launch stockpiling was heavily debated and was only introduced at a late stage of the legislative process.

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