The European Commission has proposed changing intellectual property rules to allow generic and biosimilar drug manufacturers to sell their products in markets outside the EU before the patents expire in Europe. Doing so, the Commission says, will create jobs and growth in the European Union.
The news has sparked strong opposition from pharmaceutical companies, however, which say the change would disincentivise investment in research and development.
The proposed changes target Supplementary Protection Certificates (SPCs), which extend patent protections for drugs that require extensive testing before gaining regulatory approval. This prevents European generic and biosimilar drug makers from producing these drugs within the EU for a period of up to five additional years.
If introduced, the “export manufacturing waiver” would allow manufacturers of generics and biosimilars to begin making the drugs for export to markets outside of the EU before the SPC protection period has ended. The changes would therefore allow companies to launch generic and biosimilar versions in Europe more quickly once the SPC protections end, reports Science Business.
The proposal “could generate €1 billion net additional sales per year and up to 25,000 new jobs over 10 years,” EU industry commissioner Elżbieta Bieńkowska said in a statement on Monday.
Medicines for Europe, which represents manufacturers of generic drugs, welcomed the Commission’s proposal, saying the changes would “increase access to medicines for patients, lower drug costs for national health budgets and benefit a dynamic European industry,” Science Business reports.
Jacek Glinka, vice-president and treasurer of Medicines for Europe and European president of generics group Mylan, also noted the waiver’s potential to increase employment opportunities and boost net sales to the EU pharmaceutical industry, according to Irish Times.
“The current regime impedes the growth of additional pharmaceutical manufacturing in Europe and in particular in Ireland, which given its impressive track record in this area, would be in pole position to make investment gains,” he said on a recent visit to Dublin.
However, numerous pharmaceutical companies have expressed concerns that the waiver would undermine existing intellectual property rules and weaken incentives for companies to invest in research and development.
The European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents 40 leading pharmaceutical companies, said it is “deeply concerned” with the proposal.
“The Commission’s proposal reduces IP rights and thereby jeopardises patient access to innovative treatments,” EFPIA said in a statement quoted by Science Business. “It also sends a global signal that Europe is weakening its commitment to IP, putting this investment, these jobs, this opportunity for economic growth and the advancement of patient care in Europe at serious risk.”
The EU executive emphasised that it remained committed to upholding intellectual property rights.
“We are not undermining current intellectual property rules; it’s not about rewarding one side to the detriment of the other,” Bieńkowska said, according to Science Business. “We are opening a little bit the doors for other companies.”
In order for the changes to take effect, the proposal must be approved by all 28 EU member states.