EFPIA warns that SPC waiver will weaken EU IP framework
The supplementary protection certificate (SPC) manufacturing waiver “sends a worrying global signal that the EU is weakening its IP framework”, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA).
The Brussels-based organisation, which represents research-based pharmaceutical companies in Europe, released a statement on the matter yesterday, October 17.
In May, the European Commission announced its plan to introduce a manufacturing waiver in relation to Regulation 469/2009, which governs the grant and scope of SPCs.
Although the proposed waiver was due to be implemented by 2019, lawyers recently told LSIPR that the adoption of the proposal may be delayed by both the European Parliament and the Commission coming to the end of their terms.
The EFPIA first released a statement in strong opposition to the waiver after the Commission’s plan was revealed.
The association said that the waiver “reduces IP rights and thereby jeopardises patient access to innovative treatments”, indicating to the rest of the world that the EU has lessened its commitment to IP.
Yesterday, the EFPIA reiterated its concerns in a similarly strongly worded statement.
“For patients, the European research-base and wider economy, it is vital to maintain and develop Europe’s IP framework, the foundation on which all medical innovation is based,” the statement said.
To implement the waiver would send a “worrying” signal to the rest of the world that the EU is weakening its IP framework, the EFPIA added, so it is “critical” that the waiver is accompanied by appropriate safeguards to avoid “further erosion” of this framework.
The EFPIA concluded: “The SPC is part of an incentives framework that helps to generate the €35 billion ($40.27 billion) in investment in R&D in Europe by the research-based industry.
“It helps to safeguard over 750,000 jobs directly employed by biopharmaceutical companies and critically facilitates research into unmet medical needs, finding treatments and cures for patients across Europe and beyond,” the organisation added.
Other associations, including the Irish Pharmaceutical Healthcare Association, have similarly said that the proposed waiver could lead to the development of less innovative medicines.
On the other hand, Medicines for Europe, which represents the interests of generic and biosimilar pharmaceutical companies, called the proposal “essential for patient access to medicines and pharmaceutical manufacturing in Europe.
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