One of the key changes to the legislation – and the focus of much debate – is a review of the rules regarding regulatory data protection.
In the draft text of the new Directive, the Commission devotes an entire chapter to regulatory data and market protection. The proposed new framework is more complicated than the current rules, with a shorter basic period of protection which can then be extended if various conditions (which are aimed at promoting certain public health objectives) are satisfied.
1. A standard regulatory data protection period of 6 years which may be prolonged
The regulatory data protection period is the period during which applicants for a marketing authorization for a new generic, hybrid or biosimilar medicinal product cannot submit an application referring to the dossier of another authorized reference medicinal product.
Under the current Directive 2001/83/EC, the regulatory data protection period consists automatically of a fixed period of eight years.
The Commission now proposes to reduce this to a fixed period of six years (the base period).
The base period may be extended if certain conditions are met. The length of this extension will vary as the extension periods can apply cumulatively, depending on which criteria are met.
The conditions that allow a prolongation are as follows:
A. The medicinal product is made available in all Member States within 2 years
If the product is released and “continuously” supplied in a “sufficient” quantity and in the presentations necessary to cover the needs of the patients in all the Member States covered by the marketing authorisation, an additional period of two years data protection will be granted.
This must be achieved within two years from the date when the marketing authorisation was granted, or within three years if the marketing authorization holder is an SME, a not-for-profit entity or a company that, by the time of grant of the authorisation, has received no more than five centralised marketing authorisations, for that undertaking or group since its establishment.
B. The medicinal product addresses an unmet medical need
If the marketing authorisation applicant demonstrates at the time of the initial marketing authorisation application that the medicinal product addresses an unmet medical need, an extra regulatory data protection of 6 months will be granted.
This will be the case if at least one of the therapeutic indications of the product relates to a life threatening or severely debilitating disease with remaining high morbidity or mortality, and the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality. The criteria defining an unmet need will be further specified in implementing acts.
C. Comparative clinical trials have been performed
If the medicinal product contains a new active substance, and the clinical trials supporting the initial marketing authorisation application use a relevant and evidence-based comparator in accordance with scientific advice provided by the EMA, an extra period of six months will be granted.
D. Additional therapeutic indication
If during the data protection period, an authorisation is obtained for an additional therapeutic indication for which clinical benefit in comparison with existing therapies is demonstrated, an additional data protection period of one year will be granted.
The period of regulatory data protection is followed by a period of market protection of two years, during which a product authorised as a generic, hybrid or biosimilar cannot be placed on the market.
With the additional variable protection periods, the total period of regulatory protection (data and market protection) can add up to a maximum of 12 years, which is one year more than the maximum under the current Directive 2001/83/EC. However, the appropriateness of these proposed protection periods, particularly in terms of encouraging innovation, is expected to be subject to ongoing debate during the legislative procedure.
2. Regulatory data protection period of 4 years for repurposed medicinal products
Moreover, the proposal also contains a possibility to obtain a regulatory data protection period of 4 years for repurposed products which have already been authorised.
This regulatory data protection period is unconnected to the above-mentioned data protection possibilities and will be granted for a new therapeutic indication not previously authorised in the Union (subject to certain conditions). It may only be granted once for any given product.