This article discusses the implementation of an exemption to the exclusive right of the patentee in the Netherlands which allows pharmacists to prepare drugs which are still protected by patents.
Drug pricing and reimbursement has received quite some attention lately in the Dutch media and politics, fueled by high cost of new (often orphan) drugs and unexpected price increases of existing drugs.
The discussion has now resulted in the legislator implementing an exemption to the exclusive right of the patentee as per 01 February 2019. The following sentence is now included in article 53 (3) DPA (DPA exemption):
"The exclusive right shall also not extend to the preparation for direct use for the purpose of individual cases on medical prescription of drugs in pharmacies, nor to acts regarding the drugs that are prepared as such”.
The DPA exemption allows pharmacists to prepare drugs which are still protected by patents.
The explanatory memorandum to the new paragraph of the DPA provides some guidance as to the scope of the exemption. It mentions that the DPA exemption makes it possible for a pharmacist in individual cases to prepare the patented drug without consent of the patent holder, for example when a dosage or method of administration suitable for an individual patient is not available.
The explanatory memorandum further mentions that the DPA exemption does not aim to allow for the preparation of a patented drug on a structural scale without the consent of the patent holder, because this would undermine the exclusive right of the patent holder.
The exact scope of the exemption will be determined by the courts in future case law. Patentees should monitor the market closely and consider acting against pharmacies that misuse the DPA exemption. Please note that the DPA exemption is in addition to the exemption for pharmacists to manufacture and provide drugs without a valid market authorisation which was implemented in the Dutch Medicines Act more than a decade ago as implementation of Articles 3(1) and (2) of Directive 2001/83/EC.
The latter exemption allows for small scale preparation of a drug in the pharmacy to be handed out in that pharmacy to specifically identified patients without the need for a market authorisation (DMA exemption). The scope of the DMA exemption has been the subject of some case law in recent years.
The CJEU in Abcur (C-544/13 and C-545/13) ruled that the exemption in Directive 2001/83/EC for pharmacies to prepare drugs in accordance with a medical prescription for an individual patient (magisterial preparation) without the need for an MA does not apply to a supply system based on 'subscription' nor on a system based on estimated short-term needs with respect to a drug that is not prepared specifically for a pre-identified, specific patient. Further the CJEU ruled that the fact that there are registered drug alternatives available is irrelevant for the applicability of the exemption.
Further the highest Dutch administrative Court ruled that the presence of a large quantity of raw materials, the use of mixing vessels and a tableting machine and the associated investments made by a pharmacy were indications of industrial preparation which is not allowed under the DMA exemption.
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