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Hearing: Reimbursement of off-label use of medicinal products
In accordance with the provisions of the Act on Medicines and the appurtenant Regulation on Medicinal Products, pre-approved reimbursement for use of a medicinal product outside the approved indications of the marketing authorization is not allowed.
3rd February this year, the Ministry of Health and Care issued a hearing, proposing an amendment of the Regulation on Medicines to include pre-approved reimbursement outside the approved indications of the marketing authorization. In accordance with section 14-10 of the existing Regulation, it is a prerequisite that the medicinal product has an MA for the indication the reimbursement is applied for.
In the hearing letter, it is stated that pre-approved reimbursement may be suitable in certain cases, so that the medicines become more available. The drug substance alendronate is used as an example.
In Norway, there are several medicines containing alendronate which have been granted a marketing authorization. However, none of the medicinal products placed on the Norwegian market is approved for the prevention of corticosteroid induced osteoporosis. According to the hearing letter, this indication has been approved for alendronate in several other countries, including Sweden, Great Britain and Germany.
The hearing letter states that the Norwegian Medicines Agency considers alendronate as cost efficient for patients who have initiated long term systemic treatment with corticosteroids.
An expansion of reimbursement for alendronate has previously been mentioned by the Ministry of Health and Care when issuing the proposal to Stortinget (the Norwegian Parliament) for the budget year 2012. In this proposal, it is assumed that an amendment of the conditions for reimbursement could mean that 40.000 new patients will get alendronate reimbursed. 15.000 of these are patients which already use, or in the future will use, corticosteroids for an extended period of time.
The Norwegian Medicines Agency has proposed that as a minimum requirement, the medicinal product must be approved for the indication in another EU/EEA-country.
In the proposed amendment, this is also the only other criteria. The Agency will therefore be able to make an exception from the requirement of approved indication provided that the medicinal product has a MA for the particular indication in at least one other EU/EEA-country.
According to the Ministry, the provision for pre-approved off-label reimbursement should only apply in particular cases to avoid undermining the financial interests of the market participants.
The hearing letter focuses much on the economical benefits of amending the Medicines Regulation. An aspect that is not even mentioned is the obligations to Directive 2001/83.
Article 5 nr 1 provides member states with the right to exclude the provisions from the Directive on certain conditions:
“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 European Court of Justice has recently interpreted the reach of Article 5 nr 1 in C-185/10 (Commission vs. Poland). In the Polish Law on Medicinal Products, a provision allowed the placing of imported generic medicinal products on the Polish market, although the generic did not have a marketing authorisation in Poland but only in other countries. The requirement was that the price of the imported medicine was competitive compared to those that had a marketing authorization.
The Court of Justice found that the provision in the Polish Law on Medicines was in breach of the Directive. Article 5 nr 1 is not concerned with the organization of the health-care system or its financial stability, but is only applicable in exceptional cases where it is appropriate to meet special medical needs.
The Court expressively states that “Article 5(1) of the directive cannot therefore be relied on to justify a derogation from the requirement for a marketing authorisation for reasons of a financial nature.”
The Court of Justice also states that although “EU law does not detract from the power of the Member States to organise their social security systems and to adopt, in particular, provisions intended to govern the consumption of pharmaceutical products in order to promote the financial stability of their health‑care insurance schemes, the Member States must, however, comply with EU law in exercising that power.”
In accordance with article 4 nr 3 of the Directive, the provisions of the Directive does not affect the Member States’ power to setting prices for medicinal products, nor their inclusion into national health insurance schemes. The ECJ has with the recent decision made it clear that Member States are not allowed to violate the Directive when governing their national health-care insurance schemes.
A question could be raised whether or not the proposed amendment of the Ministry, should it be implemented, would be considered as a violation of the Directive. The recent ECJ decision concerned off-license use of medicinal products, and not off-label use, and is thus not directly applicable. It is however clear from the hearing letter that the motivation for the Ministry is primarily financial.
It may seem like the authorities encourages the physicians to prescribe off-label and that the motivation to a large extent is economical. It could be argued that this undermines the EU legal framework for medicinal products.
It could also be argued that a practice that encourages physicians to prescribe off-label when other medicinal products are approved of said indication are available, undermines the purpose and the authority of EUs regulatory framework. It is especially interesting to see that the ECJ did not accept Poland’s argument that the imported medicinal product was approved in another member state and therefore assuring the safety of the patients.
The time limits for comments for the amendment proposal were 19th March 2012, after ECJ passed its judgment. It is proposed in the draft of the provision that the amendment enters into force immediately.