‘Minister Bruins: reform the granting of supplementary protection certificates for new medicines’

11/12/2018 - News

The granting of supplementary protection certificates for new medicines must be reformed. This is our message in a letter to Minister Bruins (Dutch Ministry of Health, Welfare and Sport), signed by Wemos, Aidsfonds, Commons Network, the Dutch Pharmaceutical Accountability Foundation, Health Action International (HAI) and the Centre for Research on Multinational Corporations (SOMO).

We are concerned about the role of what are referred to as supplementary protection certificates (SPCs). These certificates give pharmaceutical firms up to five years of additional protection for their medicinal product after the 20-year patent right period has ended. SPCs were introduced to compensate companies for the time it takes to bring an ‘innovative’ product to the market and are thus intended to stimulate medicinal innovation in the European Union (EU). However, a study by Technopolis Group found no evidence to support this claim. The process of issuing an SPC does not take into account the extent to which an ‘innovation’ has added therapeutic value. An extended patent also means a longer period with no competition, which causes prices to remain high. SPCs therefore burden society with unwanted high costs, as shown in the report.

For affordable, accessible medications

Based on this study, the organisations – including Wemos – are calling upon the minister to radically reform the granting of SPCs. In the letter, we propose only issuing SPCs in the Netherlands when companies can publicly prove that they have not recouped their development costs during the patent period. We additionally call upon the minister to push for reforms at EU level as well. During the procedural meeting of the Ministry of Health, Welfare and Sport on 5 December, it was decided that the minister must respond to our letter. Tom Buis of Wemos: ‘SPCs are currently imposing major burdens on society with no proven positive effect on innovation. The Dutch government now has an opportunity to show that it is still a frontrunner in the area of pharmaceutical policy. Other European countries will be following this discussion on SPCs closely; changes to the policy could lead to lower costs there as well.’

Read our letter to Minister Bruins (in Dutch)

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