By Ellen ‘t Hoen LLM, PhD, Medicines Law & Policy www.medicineslawandpolicy.org

On 1 February 2019, article 53(3), second sentence of the Dutch Patent Act 1995 came into force introducing a patent exemption for the preparation of medicines in a pharmacy.

Article 53(1) of the Dutch Patent Act provides the usual list of exclusive acts reserved for the patent holder: to make, use, put on the market or resell, hire out or deliver the patented product, or otherwise deal in it in or for his business, or to offer, import or stock it for any of those purposes. The law now provides an exemption for pharmacy preparation to these exclusive acts. The new provision reads:

“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.”

In a letter to parliament, the minister describes the conditions under which pharmacy preparation may take place: the medicine has to be for individual patients and on prescription by a physician and not for production on a structural scale. Other European countries have similar patent exemptions for pharmacy preparation in their patent laws. The introduction of the pharmacist exemption was recommended to the government by the Council for Public Health and Society in its report Development of new medicines; Better, faster, cheaper of November 2017.

The pharmacists who are preparing low-cost medicines are popular in the Netherlands.

For example, the pharmacy of the Amsterdam University Medical Centre received €5 million from the Vrienden Lotterij (Friends Lottery) for the preparation of chenodeoxycholic acid (CDCA) for the treatment of  cerebrotendinous xanthomatosis (CTX), a rare metabolic disease. Leadiant, the company that sells the product commercially, had increased the price of the product 500 fold to €153,300 per patient per year. Leadiant has a monopoly position in the market since it obtained an orphan drug status for the product in the EU. The Pharmaceutical Accountability Foundation has requested the Dutch competition authority to take action against Leadiant. In the mean time, the pharmacy preparation can offer relief for CTX patients that depend on the medicine. See (https://medicineslawandpolicy.org/2018/08/new-dutch-foundation-to-address-high-medicines-pricing-announces-plan-to-file-complaint-with-competition-authority/) here for more information about the CDCA story.

Continue reading: https://medicineslawandpolicy.org/2019/02/faced-with-unreasonable-medicines-prices-the-netherlands-introduces-pharmacy-exemption-in-patent-law/