May 22, 2023

The European Commission Proposes First Major Overhaul of the EU Medicines Regulatory Framework in 20 Years: Regulatory Data Protection


We recently published an alert in relation to the European Commission’s legislative proposals to replace the current EU regulatory framework for all medicines (including those for rare diseases and for children). One of the major elements of the proposals is a change to the period of regulatory data protection for medicines, which we examine in more detail in this article.

Current Regulatory Data Protection Period

Currently in the EU, new medicines receive an eight-year period of data exclusivity, during which applicants for generics or biosimilars cannot refer to the preclinical tests and clinical trial data contained in the dossier of the reference medicine. This is immediately followed by a two-year period of market exclusivity during which generics or biosimilars cannot be placed on the market.

The overall 10-year period of regulatory data and market protection will be extended to a maximum of 11 years if, during the first eight years of those 10 years, the new medicine is approved for an additional therapeutic indication that is held to bring a significant clinical benefit in comparison with currently approved therapies.

Proposed Regulatory Data Protection Period

Under the legislative proposals, the standard data exclusivity period will be reduced to six years, to which is added a two-year period of standard market exclusivity. New medicines may benefit from additional periods of data exclusivity, increasing the overall regulatory data and market protection period up to a maximum of 12 years, with additional increments being available in the following circumstances:

  • Two additional years for medicines continuously supplied in EU Member States
    • Medicines can receive an additional two years of data exclusivity if the marketing authorization holder (MAH) can show that it meets the following conditions within two years of receiving a marketing authorization: the MAH has released and continuously supplied a sufficient quantity of the medicine in the presentations necessary to cover the needs of patients in the EU Member States where the marketing authorization is granted. There is no guidance yet as to what is meant by “sufficient quantity” and “presentations necessary” in this context.
    • The MAH must provide documentation from EU Member States where the marketing authorization is granted as evidence that it has released and continuously supplied the medicine (this requires a confirmation from the EU Member State, although a positive pricing and reimbursement decision is considered equivalent). Alternatively, if the MAH fails to satisfy this requirement in respect to a particular EU Member State, the MAH must have a relevant statement of non-objection from each such EU Member State to extend the period of data exclusivity.
    • The two-year deadline is extended to three years for MAHs that are: (1) micro, small, and medium-sized enterprises (i.e., enterprises that employ fewer than 250 persons and that have an annual turnover not exceeding EUR 50 million, and/or an annual balance sheet total not exceeding EUR 43 million) (SME); (2) not-for-profit entities; or (3) MAHs that, at the time of granting the marketing authorization, have received (whether themselves or in their group of companies) not more than five marketing authorizations under the centralized procedure.
    • To obtain the additional two years of data exclusivity, the MAH must apply for a variation 34 to 36 months after the marketing authorization is granted (or 46 to 48 months for SMEs, not-for-profit entities, and MAHs with not more than five centralized marketing authorizations, as discussed above).
  • Six additional months for addressing an unmet medical need
    • Medicines can receive an additional six months of data exclusivity if, at the time of granting the marketing authorization, the medicine addresses an unmet medical need. A medicine will be considered to meet an unmet medical need if it is an orphan medicine or if it satisfies certain conditions.
    • These conditions are as follows: (1) at least one of its therapeutic indications relates to a life-threatening or severely debilitating disease; and (2) (i) there is no medicine approved in the EU for such disease, or, where despite medicines being approved for such disease in the EU, the disease is associated with remaining high morbidity or mortality; and (ii) the use of the medicine results in a meaningful reduction in morbidity or mortality for the relevant patient population.
  • Six additional months for new active substances (NASs) undergoing clinical trials against the relevant comparator
    • An additional six months’ data exclusivity will be given to medicines that contain a NAS and whose initial marketing authorization includes data from clinical trials that use a “relevant and evidence-based comparator” in accordance with scientific advice provided by the European Medicines Agency.
  • One additional year for a new therapeutic indication providing significant clinical benefit
    • Akin to the current regime, medicines can receive an additional year of data exclusivity if they are approved during the data exclusivity period (i.e., six years) for an additional therapeutic indication that will provide a “significant clinical benefit” over currently approved therapies. This extension can be granted only once and will not apply to orphan medicines that benefit from extended periods of data exclusivity.
The proposed regulatory data protection regime will not apply: (1) if an MAH grants a third party access to its data; or (2) in the case where a compulsory licence has been granted to a third party by an EU Member State to address a public health emergency.

Practical Implications

The conditions for extended regulatory data protection under the new regime currently lack clarity in some places. For example, elements of the two-year extension available where medicines are continuously supplied in EU Member States are unclear, including what is meant by “sufficient quantity” and “presentations necessary.”

Although the theoretical maximum possible period of regulatory data protection under the proposals is longer than under the current regime, some medicines will, relative to the current regime, have a reduced period of regulatory data protection if they cannot satisfy the conditions for any of the available extension periods.

As a final note, if an application for a marketing authorization has been submitted before the new regime enters into force, the medicine will benefit from the current regime.