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Monday, 2 April 2012

CJEU declares Poland's law on cheap drugs contrary to EU Law

The IPKat was perusing Twitter on his way to work, and was struck by this article from Pharma Times online.

A little digging and blogmagisterial assistance revealed the case to be C-185/10.  The English-language judgement is available here, while the CJEU press release is here.

The Polish law at issue, Article 4 of the Law on Medicinal Products, was as follows:

1. Subject to the reservation in paragraphs 3 and 4, medicinal products imported from outside Poland may be placed on the market without the need to obtain authorisation for them if their use is necessary for the purpose of saving the life or safeguarding the health of a patient, on condition that the medicinal product in question is allowed to be marketed in the country from which it was imported and holds an up-to-date marketing authorisation.
2. The basis for the importation of a medicinal product, as referred to in paragraph 1, is the requirement of the hospital or external doctor treating the patient, as confirmed by a consultant in the medical sector concerned.
3. The following medicinal products may not be placed on the market within the terms of paragraph 1:
(1) those in respect of which the minister with responsibility for health-related matters has issued a decision refusing to grant authorisation, refusing to extend the duration of validity of an authorisation, or revoking authorisation; and
(2) those containing the same active substance or substances, the same dosage and having the same form as medicinal products which have obtained authorisation, subject to the reservation in paragraph 3a.
3a. The rule in paragraph 3(2) shall not apply to medicinal products, as referred to in paragraph 1, the price of which is competitive in relation to the price of the medicinal product which has obtained authorisation within the terms of Article 3(1) or (2), on condition that the requirement has been expressed by a health insurance doctor and has been confirmed by a consultant in the medical sector concerned, and that the minister with responsibility for health-related matters has expressed, by way of a decision, his agreement to the importation of those products.
4. Medicinal products, as referred to in paragraph 1, which, having regard to the safety of their application or the scale of importation, must be granted marketing authorisation pursuant to Article 3(1), may also not be placed on the market.
5. Pharmacies, wholesalers and hospitals engaging in the commercial sale of medicinal products, as referred to in paragraph 1, shall maintain a register of those products.
6. On the basis of that register, a pharmaceutical wholesaler shall forward to the minister with responsibility for health-related matters, no later than 10 days after the end of each quarter, a summary list of imported medicinal products.

The Commission took issue with para 3a, permitting medicinal products to be sold without authorisation in Poland, provided "the price ... is competitive" with the authorised product.

This provision was considered by the Commission to contravene Art 6(1) of the Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, which states:
No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EC) No 726/2004 [the Regulation concerning grant of EU authorisations] 
Poland argued that their law fell within the exception of Art 5 of the Directive (the "special needs" exception), which states:
A Member State may, in accordance with legislation in force and to fulfil special needs, exclude from the provisions of this Directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised health-care professional and for use by an individual patient under his direct personal responsibility.
The CJEU was having none of it, and completely backed the Commission's view.  In particular it held:
Where medicinal products having the same active substances, the same dosage and the same form as those which the doctor providing treatment considers that he must prescribe to treat his patients are already authorised and available on the national market, there cannot in fact be a question of ‘special needs’, within the meaning of Article 5(1) of Directive 2001/83, necessitating a derogation from the requirement for a marketing authorisation under Article 6(1) of that directive. 
Financial considerations cannot, in themselves, lead to recognition of the existence of such special needs capable of justifying the application of the derogation provided for in Article 5(1) of that directive.
The CJEU therefore held Article 4 of the Polish law to contravene the Directive 2001/83/EC.

The IPKat is thinking...
It seems to the IPKat that the offending para 3a of Article 4 was an attempt by Poland at a law allowing generic pharmaceuticals without the need for the abbreviated authorisation procedure that exists for such generics.  The Commission and the CJEU perhaps unsurprisingly wanted the EU order to prevail.  However, the EU system requires the generic provider to seek the authorisation, and so does not assist where no generic provider has sought authorisation.  How should the law address such situations?






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