18 February 2019
Pharmacy compounding of patented medicines in the Netherlands
Hein van den Bos, partner
The pharmacy exemption came into force on 1 February 2019 ￼
In many other European countries (such as Germany, France and the UK), pharmacists were already allowed to prepare a patented medicine on a small scale for their own patients under a pharmacy exemption. This was not the case in the Netherlands, at least, not until 1 February 2019.
Article 53(1) of the Dutch Patent Act 1995 ("DPA") provides a list of exclusive acts reserved for the patent holder. On 1 February 2019, Article 53, third paragraph, second sentence, of the DPA came into force and introduced a pharmacy exemption in Dutch patent law. Article 53, third paragraph, second sentence of the DPA reads as follows (unofficial translation):
"3. […] The exclusive right shall neither extend to the preparation for direct use for individual cases on medical prescription of medicines in pharmacies, nor to acts concerning the medicines thus prepared."
The pharmacy exception is meant for the preparation of pharmaceuticals, by pharmacists, for direct use, on prescription, in individual cases. In a letter to the House of Representatives, the responsible ministers have clarified that this exception does not aim to allow preparation of a patented medicinal product on a structural scale without the consent of the patent holder, as this would undermine his right.
The entry into force of the pharmacy exemption in the DPA reflects a broader trend in the Netherlands of government favoring pharmacy compounding, also as a potential alternative to expensive medicinal products.
At the end of 2018, the Dutch Health and Youth Care Inspectorate ("IGJ") published a report about the pharmacy compounding of a specific medicinal product by a Dutch hospital pharmacist. The report's general conclusion is that pharmacy compounding by pharmacists for their own patients is allowed, even if (more expensive) registered alternatives are available. IGJ did note that pharmacists should make sure that the compounded medicinal product meets the safety and quality requirements, and should take into consideration that advertising of pharmacy compounded medicinal products is not permitted.