In May this year, the European Commission (EC) suggested the adoption of an ‘export manufacturing waiver’ to the Supplementary Protection Certifications (SPCs) that extend patent protection.
The waiver would enable companies to make drugs covered by SPCs at facilities in Europe, on the condition that the products are intended for export to markets where patent protection has expired or never existed.
At the time, the EC’s vice-president for jobs, growth, investment and competitiveness, Jykri Katainen, said the proposal represents a “well-calibrated adjustment to the current regime to remove a legal barrier that was preventing our companies from competing on equal terms on global markets where competition is fierce”.
“We want to make sure that our pharmaceutical industry reaps the benefits of such competition,” he added.
According to EC commissioner for internal market, industry, entrepreneurship and SMEs (small and medium-sized enterprises), Elżbieta Bieńkowska, the scheme “strikes a balance between the imperative to ensure the attractiveness of Europe for innovate pharmaceutical companies and the urgency to allow EU based generics and biosimilar to compete on the global markets.”
“This will help create growth and high-skilled jobs in the EU,” she added.
However, according to IPHA director of communications and advocacy, Bernard Mallee, the proposed waiver represents a threat to industry innovation.
The Irish Pharmaceutical Healthcare Association (IPHA) was founded to advocate group for the pharmaceutical industry in the Republic of Ireland.
“Intellectual property (IP) rights are the scaffolding for innovation. Unfortunately, they face the prospect of being weakened by the EC’s proposal to shorten patent periods under the SPC waiver,” Mallee told us.
With more than half of patent periods in a number of territories, including Ireland, being taken up by discovery and development, Mallee said the SPC acknowledges bringing a product to market is high-risk and high-cost.
An “erosion of IP rights could mean fewer innovative medicines make it to market and planned investments are delayed”, he added.
Mallee continued: “As the legislation is shaped in the coming months, we have an opportunity to ensure certain safeguards are built in, including that the SPC waiver only applies for export to countries where there is no intellectual property protection or where it has expired, and that there be no scope for the retrospective application of the new rules.
“It is vital that the incentive to innovate, created by IP rights, is not further undermined.”
The Republic of Ireland has attracted increased attention as the UK prepares to withdraw from the European Union. Last month, industry representatives spoke out against the implementation of a hard border with Northern Ireland, which BioPharmChem (IBEC) said could threaten drug import and export policy, and impact drug delays.