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Pharma­cist exemption

Pharma­cist exemptionOn 1 February 2019, a pharmacist exemption came into effect in Dutch patent law. This appears to be the result of the public debate surrounding the high price of patented medicines. It should be noted, however, that this exemption only applies to medically necessary preparations of these medicines.

 

Removing ambiguity

The reason given for the entry into force is that there is a lack of clarity about the possibilities for pharmacists to proceed to self-preparation within the limits of the law. However, as can be read in the provision, the exemption specifically relates to "...the preparation for direct use for individual cases on medical prescription of medicines in pharmacies..." (Art. 53(3) of the 1995 Patents Act (ROW95).

Customised preparations

So this is not about offering self-prepared medication at a lower price. It follows from legal history, which goes back to before the current debate, that the pharmacist exemption is intended for cases in which a dosage or method of administration of the patented medicine suitable for an individual patient is not available. This is therefore only available for cases of medically necessary customised preparations. Moreover, it follows from the international TRIPs Treaty that Dutch patent law may not contain exemptions that unreasonably disadvantage the interests of the patent holder<

No alternative

The pharmacist exemption has entered into force in accordance with the TRIPs Treaty. In this way, the exemption does make the preparation of a patented medicine possible, but only if the preparation by a pharmacist is medically necessary. For the time being, it therefore does not appear to be possible to use the preparation by pharmacists as an alternative to patented medicines.<

Onderwerpen: Medicines, Patent, Rules and procedure, General, Intellectual Property