Dive Brief:
- The European Commission is tweaking its intellectual property rules to boost opportunities for European drug manufacturers outside the EU boundaries.
- The "export manufacturing waiver" will be added to supplementary protection certificates (SPCs) to allow European companies to manufacture generic and biosimilar forms of SPC-protected drugs during the term of the certificate, provided it is for export to non-protected non-EU markets.
- The proposal was announced in the Commission's 2015 Single Market Strategy. There will be safeguards surrounding the proposal, including increased transparency and ways to prevent IP-infringing products from entering member state markets.
Dive Insight:
The global medicines market worldwide hit more than 1 trillion euros (around $1.16 trillion) in 2017, and the generics and biosimilars share is growing. According to MarketLine, the global generics market, worth around $318 billion in 2016, is likely to grow at double digit rate through 2021.
The U.S. is the largest single country market, with a value of $99.7 billion, and still has room for growth, potentially up to $141.2 billion by 2021, according to that report. Asia-Pacific makes up 46% of the global total, and the U.S. 31%. This creates a huge market that European manufacturers could tap into for generics alone, and the growing biosimilars market in the U.S. adds yet more opportunities.
The role of an SPC is to extend the patent life of a drug for up to five and a half years beyond the normal patent expiry, in order to offset the extended development process. However, these do put EU-based manufacturers of generic and biosimilar drugs at a disadvantage against industry outside the EU.
The aim of this change is to maintain Europe "at the forefront of pharmaceutical research and manufacturing," according to EC VP Jyrki Katainen, responsible for jobs, growth investment and competitiveness.
"Today's proposal strikes a balance between the imperative to ensure the attractiveness of Europe for innovative pharmaceutical companies and the urgency to allow EU based generics and biosimilars to compete on the global markets. It could generate €1 billion [$1.16 billion] net additional sales per year and up to 25,000 new jobs over 10 years," according to Elżbieta Bieńkowska, EC commissioner for internal market, industry, entrepreneurship and SMEs.