The Embassy of the United States has entered the debate around high priced medicines in the Netherlands and released a statement that expresses concern about the Dutch government’s exploration of legitimate intellectual property management tools to protect public health.
The Embassy statement uses veiled threats about the potential damage to the Dutch investment climate, conjures a misguided and unfounded image of risks to patient safety and public health posed by the pharmaceutical compounding, and gives the impression of cheap copies of patented medicines flooding the market.
This is nothing short of scaremongering in an effort to put the brakes on attempts by a country to exercise its sovereign right to use legitimate and legal tools to protect public health and promote access to medicines for all.
The US statement is wrong on a number of levels. Firstly, compulsory licensing (CL) has always been part of Dutch patent law – as is the case in all countries including the US. A commission established by the Dutch Minister of Health and the Minister of Economic Affairs is now studying the question whether and how compulsory licensing can be used to bring the cost of medicines down.
Secondly, the decision to use these tools is not one to be taken lightly. The idea that “patented medicines to simply be replaced by a cheaper, non-patented copy” is a false one. Only where companies raise prices to such excessive levels that patient access is put at risk and attempts at negotiating more acceptable prices fail do these mechanisms enter the fray.
Thirdly, the other issue being called into doubt here—pharmaceutical compounding—is subject to strict compliance of pharmacist professional standards, and adherence to European Pharmacopoeial standard of the raw materials. The Netherlands Health Inspectorate (IGJ) is closely monitoring pharmaceutical compounding in the interest of protecting patients. Again, to suggest that patient safety is at stake is misleading.
Compulsory licenses have been used to great effect in the past to ensure access to antiretrovirals for the treatment of HIV/AIDS and other diseases, predominantly in the Global South. But their use was never intended to be limited to that socio-economic or geographic area. As health systems in the Global North come under increasing pressure from ever more expensive medicines coming on to the market, it is more important than ever that intellectual property management conducive to protecting public health is considered an integral part of the policymakers toolkit.