On 26 April 2023, the European Commission adopted the EU Pharmaceutical Legislation Package, a major set of reforms that aims to make medicines more available, accessible, and affordable. Some of the key proposed changes are to the regulatory data, market protection, and orphan market exclusivity regimes.

On 10 April 2024, the European Parliament adopted its position on the Commission’s Proposal. More than a year later, the European Council set out its own position on 4 June 2025. Overall, the Council suggests some reductions in the length of protection and the quality of protection provided (relative to the current regime), but the proposals also include some options for additional exclusivity in certain circumstances. Negotiations between the Council, the Parliament and the Commission have now commenced and are anticipated to take several months. It is to be expected that the proposals will evolve further before being finalised, and the transitional provisions mean we have some years before things change in practice. However, it looks increasingly likely that the current regime will be over in the next decade, which has particular relevance for doing diligence on early-stage products.

Regulatory Data Protection and Market Exclusivity

The Council’s proposal includes significant changes to the regime applicable to newly approved medicines, which currently fall under the “8+2+1” regime. As standard, such medicines currently benefit from 8 years of regulatory data protection (“RDP”) and 2 years of market exclusivity (“ME”), with a potential extra year of ME protection on the basis of a new therapeutic indication (the “+1”).

Under the Council’s proposed amendments, the RDP period for medicines will remain at 8 years (the original proposals from the Commission reduced the baseline period to 6 years). A one-year extension is available by application of a transferrable voucher granted for development of antimicrobial drugs (discussed further below).

The minimum period of ME following the RDP period is reduced from two years currently to one year, although this is extendable by 12 months if the medicine meets certain new criteria, such as meeting an “unmet need”, or by carrying out comparative clinical trials against the best-known drug for treatment of the disease. These two provisions were initially proposed by the Commission as 6-month extensions to the RDP period (not the ME). The Council appear to have rejected the other new extension criteria that were proposed by the Commission. As is the case at present, a further year of ME is available if an authorisation is subsequently obtained for a new therapeutic indication.

These two periods of protection are illustrated in the graphic below, under both the current “8+2+1” regime, and the Council’s proposal.

Overall, the Council’s proposal reduces the minimum period of protection (RDP + ME) from 10 years currently, to 9 years (the minimum under the Commission’s original package was 8 years).

According to the Council’s proposal, these changes to RDP and ME would take effect three years after entry into force of the new legislation (rather than 18 months after entry, as proposed by the Commission), but would not apply to products for which an application for marketing authorisation has been submitted prior to this date.

Orphan Market Exclusivity

The Council’s proposal also includes significant changes to the regime applicable to orphan medicines, which currently benefit from 10 years of orphan market exclusivity (“OME”) for each orphan indication, extendable by two years where a paediatric investigation plan has been completed.

The Council proposes:

• Standard OME of 10 years, extendable by one year if marketing authorisation is granted for a new orphan indication. This extension can be granted twice for different orphan indications, giving a maximum OME period of 12 years. This represents an increased period of exclusivity relative to that suggested by the earlier proposals from the Commission.
• Five years of protection for orphan medicinal products with an existing well-established use.

Interestingly, the Council’s position on “standard OME” is in line with the current provisions on OME, whereas both the Commission and Parliament proposed shortening this time period, and adding an additional, longer “tier” of OME for “high unmet medical need products”, which the Council have not accepted.

The Council has also approved the following further changes relative to the current regime which were included in the Commission’s reforms:

• No extension to OME for completing a paediatric investigation plan.
• Only one period of OME available per product, rather than one per orphan indication.

The Council’s proposal is illustrated below, in comparison to the current regime.

In a move favourable to generic manufacturers, under the new legislation, it will be possible to apply for (and obtain) a marketing authorisation for a generic or biosimilar product where the remaining duration of OME is less than two years.

Under the Council’s proposal, these changes would now be expected to come into force three years after entry into force of the new legislation, rather than 18 months as proposed by the Commission. However, it does not appear to be immediately clear what the effect will be on outstanding periods of OME as we move through the transition period.

Transferable Exclusivity Voucher for Antimicrobials

The Council has adopted the Commission’s proposal for a transferable exclusivity voucher to incentivise the development of new antimicrobials. The voucher will be granted to a marketing authorisation holder when a new priority antimicrobial drug is approved. The voucher can be freely transferred to other innovators and then be used to give an additional year of RDP for any product, as illustrated above in yellow in the first timeline. The Parliament had instead proposed a more complex regime under which vouchers may be granted for 6, 9 or 12 months of additional RDP, with the length of the extension determined by the perceived priority of the target pathogen.

In a change to the Commission’s proposals, the Council has stipulated that a transferred voucher can be used in only the fifth year of the RDP period, and only if the marketing authorisation holder demonstrates that the annual gross EU sales of the product have not exceeded €490 million in any of the preceding four years.

Bolar Exemption

Also of interest are the Council’s amendments to the expanded Bolar exemption introduced in the legislative package. This exemption to patent infringement applies to research activities such as clinical trials aimed at obtaining marketing authorisation for a medicine.

Under the proposals, the existing safe harbour will be expanded to cover a broader range of activities and extend to third parties supplying active ingredients for such activities. The Council appears to agree with the Parliament that the exemption should apply to the development of innovative products as well as the generic, biosimilar, and hybrid or bio-hybrid products covered by the Commission’s original proposal.

Next steps

The final form of the proposed legislation will depend on the outcome of the negotiations between the Council, the Parliament and the Commission. However, given the common themes between all the proposals, we can already see how some expected exclusivity dates for early-stage products are likely to change under this new regime, making this a key area of interest for our attorneys working on diligence projects.