EFPIA concerned over SPC waiver amendments
Proposed amendments to the EU’s supplementary protection certificate (SPC) manufacturing waiver risk “further disincentivising investment” in Europe, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA).
The Brussels-based organisation, which represents research-based pharmaceutical companies in Europe, published a statement on the amendments on Tuesday, November 27.
Earlier this month, the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) adopted compromise amendments to the waiver, in a move that would put jobs, economic growth and the advancement of patient care at risk, the EFPIA said.
In May, the European Commission proposed the introduction of a manufacturing waiver in relation to Regulation 469/2009, which governs the grant and scope of SPCs.
The waiver would allow EU companies to make generic/biosimilar versions of an SPC-protected medicine during the term of the certificate if the manufacture is done exclusively for export to a non-EU market where protection has expired or never existed.
Under the amendments, ENVI adopted a “day one” possibility, which allows for the stockpiling of generic medicines while the innovator drug is still under protection, so that generic makers can launch their products as soon as the protection expires.
This amendment, along with failing to guarantee a “robust system” for notifying innovator companies of applications for a manufacturing waiver, makes Europe a less attractive destination for life science investment, according to EFPIA.
However, Medicines for Europe, which represents the interests of generic and biosimilar pharmaceutical companies, has welcomed the amendments.
Medicines for Europe claimed that under current restrictions, the EU pharma industry is forced to delocalise production to non-EU countries, such as Canada, India, China and the US.
Adrian van den Hoven, director general of Medicines for Europe, said: “We hope that this progress, together with a more reasonable date of application, will be agreed by the European Parliament and the Council in a future final agreement.”
Although the proposed waiver is due to be implemented by 2019, lawyers recently told LSIPR that the adoption of the proposal may be delayed by both the Parliament and the Commission coming to the end of their terms. Work in the European Parliament’s eighth term ends on April 18, 2019, while the Commission’s current team is in office until October 31, 2019.
EFPIA has called on policy makers to protect medical innovation in Europe by ensuring clarity and legal certainty on what the waiver entails, the conditions under which it applies, and that it does not further reduce IP incentives for innovation.
According to the association, in practical terms, this means a timely and fair notification system and labelling measures which prevent products made under the export waiver from being re-directed back to the EU or being launched on the EU market before SPC expiry.
Did you enjoy reading this story? Sign up to our free newsletters and get stories like this sent straight to your inbox.
