The European Parliament has just adopted in first reading the “pharmaceutical package” which includes a new directive and a new regulation replacing the current patchwork of regulatory framework[1].
Some measures will have a considerable impact on medicinal product reimbursement if maintained as they are. As such, it is envisaged that marketing authorisation (MA) holders may be required to submit an application for reimbursement in all Member States and negotiate the price of their medicinal product “in good faith”.
It should be noted, however, that legislative work will continue in the coming months, and therefore the texts are likely to change.
What would be the obligations of pharmaceutical companies regarding reimbursement?
Article 58a of the proposal for the directive provides that all Member States in which a MA is valid may require the holder of that authorisation to submit an application for reimbursement.
The text also specifies that the price must be negotiated “in good faith” and within the deadlines set by the “Transparency” Directive. For the record, this directive requires Member States to reach a decision on reimbursement and price within 180 days of the application for reimbursement.
Of course, these new provisions will not prevent the MA holder from placing a medicinal product on the market of a Member State or from submitting an application for reimbursement when no Member State has made such a request.
Within what timeline should pharmaceutical companies apply for reimbursement?
Article 58a of the proposal for the directive provides that:
- within one year of the MA being granted: Member States may ask the pharmaceutical company to submit an application for reimbursement, or indicate that their request will be made at a later date;
- within one year of the Member State’s request: the pharmaceutical company must submit a reimbursement application and a price proposal. However:
- the deadline is extended to 2 years for (i) SMEs, (ii) undertakings that, by the time of granting the MA, have received (themselves or through their group) not more than five centralised MA and (iii) entities not engaged in an economic activity;
- the deadline (of 1 or 2 years) shall be extended by 6 months following the reasoned notification from the MA holder;
- the Member State and the MA holder may agree on another deadline.
What sanctions are provided for?
Article 206 of the proposal for the directive provides that non-compliance with these obligations shall be subject to the imposition of “effective, proportionate and dissuasive” financial penalties. It will be up to the Member States to set the amount.
Under what circumstances could pharmaceutical companies avoid these obligations?
Lighter obligations for orphan medicinal products and ATMPs
Article 58a of the proposal for the directive provides that, for designated orphan medicinal products and for advanced therapy medicinal products (ATMPs), pharmaceutical companies may choose to submit an application for reimbursement only in the Member States where the relevant patient population has been identified.
Exemptions to be defined
Furthermore, the proposal for the directive provides that certain medicinal products may be entirely exempt from these obligations. It is thus indicated that:
- the European Commission will specify the criteria for exemption (depending on the nature of the medicinal product or its market) and adopt a list of exempted medicinal products (taking into account the circumstances surrounding regulatory and reimbursement procedures pertaining to particular medicinal products or the impracticability of the administration of a medicinal product in most Member States);
- Member States may also decide, after requesting a pharmaceutical company to submit an application for reimbursement for a medicinal product, to exempt it from the obligations set out above.
While the European authorities’ objective is commendable, the constraints and risks that this measure would impose on pharmaceutical companies are very significant and would impact market access strategies.
For example, if it is economically unrealistic to engage in a reimbursement process in all Member States, will pharmaceutical companies have to limit the scope of their MA application?
Furthermore, what does the obligation to negotiate “in good faith” concretely entail (whose non-compliance could be heavily penalised): will it be sufficient to initiate negotiations? Will the pharmaceutical company risk financial penalties if it withdraws its application for reimbursement?
[1] More specifically:
- The new directive is expected to (i) repeal and replace Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use and Directive 2009/35/EC of 23 April 2009 on the colouring matters which may be added to medicinal products, and (ii) incorporate relevant parts of Regulation 1901/2006 of 12 December 2006 on medicinal products for paediatric use;
- The new regulation is expected to repeal and replace Regulation 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use, Regulation 141/2000 of 16 December 1999 on orphan medicinal products, and relevant parts of Regulation 1901/2006 of 12 December 2006 on medicinal products for paediatric use.