On February 26, 2019, the Committee on Legal Affairs of the European Parliament approved the draft text of the regulation on a supplementary protection certificate SPC waiver. Earlier this year, the Legal Committee of the European Parliament (JURI) has voted in favor of the SPC manufacturing waiver.
With the introduction of SPC waiver for export and stockpiling, generic and biosimilar manufacturers now will be able to produce and stockpile products within the EU countries during the last six months of the protected period. Removed manufacturing restrictions in Europe can have an impact on biosimilars market sustainability.
The institutional dimension
Probably the subtlest effects will be bared by health care institutions. They will be challenged to design and organize adequate procurement processes and to adapt to the product availability phenomena. We can expect that more alternative treatment options (biosimilars) will be available at the same time after patent expiry.
The SPC waiver amendments attract skepticism across the originator industry. EFPIA has laid out its perspective on the importance of Europe´s intellectual property (IP) framework . A study followed by IFPIA focuses on unintended consequences of weakening the IP incentives for biopharmaceutical innovation in Europe. On its side, it discusses job losses and sales losses attributed to the European innovative pharmaceutical industry.
When the new SPC waiver will apply
The amended Regulation is intended to enter into force on July 1, 2019, and will affect two categories of SPCs, depending on the time of their application – SPCs applied for after the regulation enters into effect (Cat. 1), and from July 1, 2022, all SPCs that come into effect after the waiver enters into force. (Cat. 2). The diagram below is reproduced and updated from the JURI report from November 2018.