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On 11 December 2025, negotiators from the EU Council and Parliament reached a provisional agreement on reform to the laws surrounding the regulatory exclusivity periods offered to newly-authorised pharmaceutical products in Europe (see press release from the European Parliament).
The regulatory exclusivity periods exist to compensate marketing authorisation holders for the investment required to carry out the necessary pre-clinical and clinical studies to achieve authorisation for a new product. During the exclusivity periods, there are restrictions on the extent to which any applicant for marketing authorisation for a generic / biosimilar version of the product can access or rely upon the data that supported the original authorisation. This can result in later market entry for generic / biosimilar versions of a product. The EU considered that reform of the provisions was necessary to balance the interests of various stakeholders, to improve patient access to medicines, and to increase the attractiveness of the EU as a place to develop and market new medicines.
Reform to the regulatory exclusivity periods: an "8+1+1+1" model
Once a new pharmaceutical product obtains a marketing authorisation in the EU/EEA (and UK), the marketing authorisation holder is currently entitled to (a) a "data exclusivity" period, during which no third party can rely on the published clinical data for the original product to obtain their own marketing authorisation, and (b) a "market protection" period, during which no third party can launch a product onto the market in Europe that relies on the original product's data.
The current available periods follow an "8+2+1" model, providing up to a maximum 11 years of regulatory exclusivity, as discussed in more detail in our briefing note on regulatory exclusivity.
Under the new proposals, the current regime will be replaced by an "8+1+1+1" model.
The "data exclusivity" period will remain unchanged, at 8 years.
The "market protection" period will be reduced by 1 year. Thus, only 1 additional year of market protection will be available after expiry of the data exclusivity period.
However, the market protection period will be extendible by up to a maximum of 2 years, with 1 year added to the term for each of the following criteria that are met:
- If the product addresses an "unmet" medical need;
- If the product contains a new active substance that fulfils a number of conditions relating to whether clinical trials were carried out in EU/EEA member states, and the timeliness of the application for marketing approval in the EU/EEA relative to corresponding applications elsewhere; and
- If authorisation for the same product is also obtained for one or more new therapeutic indications that bring a "significant clinical benefit" in comparison with existing therapies.
Thus, the maximum total regulatory exclusivity period, if two of the relevant additional criteria are met, remains at 11 years.
Changes to the orphan medicinal products regime
The provisional agreement also introduces some changes for so-called "orphan" medicinal products in the EU/EEA, which are developed to treat rare diseases. Orphan products currently benefit from a "market exclusivity" period of 10 years, during which no third party can launch any similar product on the market, even if the third party generates their own clinical data and even if the third party product is not structurally identical to the authorised orphan product. This is discussed further in our briefing note on orphan drugs.
Under the provisional agreement there will instead be two different 'tiers' of exclusivity awarded to orphan products.
- All orphan products will obtain a basic 9 years of market exclusivity.
- However, orphan products for diseases with a "high unmet need" – which is understood to mean diseases for which no therapy is currently available – will obtain an enhanced period, totalling 11 years of market exclusivity.
Additional data exclusivity for "priority antimicrobials"
The provisional agreement also envisages the introduction of a new "transferable data exclusivity voucher" to promote the development of new priority antimicrobial products. This voucher will enable 1 additional year of data exclusivity for any chosen priority antimicrobial product, and will be transferrable between companies.
Clarification of the "Bolar exemption" across the EU
The provisional agreement also includes a commitment to an exemption to patent and SPC infringement for manufacturers who take the necessary steps (including e.g. studies or clinical trials, regulatory submissions and procurement tenders) to be able to launch a generic medicine on the market once any IP rights protecting the originator product have expired. This provision – known as the "Bolar exemption" – already exists in European patent law, but it is typically not uniformly applied by the EU member states. The provisional agreement aims to clarify and broaden the wording and implementation of this provision.
What happens next?
The provisional agreement is a major step forwards in reform of the relevant EU/EEA legislation in this area. However, it now rests with the EU Council to formally adopt the position set out in the agreement. Then, the EU Parliament will have to pass legislation to enact these changes. It also remains to be seen whether UK legislators will decide to enact any similar reforms in the UK. We will be monitoring further developments with interest.
J A Kemp LLP acts for clients in the USA, Europe and globally, advising on UK and European patent practice and representing them before the European Patent Office, UKIPO and Unified Patent Court. We have in-depth expertise in a wide range of technologies, including Biotech and Life Sciences, Pharmaceuticals, Software and IT, Chemistry, Electronics and Engineering and many others. See our website to find out more.
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