On 4 June, the Council of the European Union (the “Council”) agreed its position on the major reforms to EU pharmaceutical law, meaning that all three of the EU institutions have now established their stance on the proposed overhaul of the legislation governing medicines for human use in Europe. 

The European Commission (the “Commission”) first proposed a revision of pharmaceutical laws in April 2023, intending to replace existing legislation with a new Directive and Regulation, generally referred to as the Pharma Package (the “Pharma Package”). The proposal aims to boost innovation and promote the competitiveness of the EU pharmaceutical industry while also enhancing medicine safety, accessibility and affordability for consumers. The European Parliament (the “Parliament”) followed with its position in April 2024, tempering some of the Commission’s suggestions. The Council then adopted its mandate for negotiations, paving the way for the Pharma Package to move a step closer towards enactment. 

The Pharma Package is comprehensive and this piece looks at a short selection of key points, now that Council’s position has been stated. 

Regulatory data protection  

• The current ‘8+2+1’ regime provides developers of innovative medicines with regulatory data protection (“RDP”) for a period of eight years, meaning that the data submitted by innovators to obtain marketing authorisation (“MA”) for a new medicine is protected from competitors to prevent them from creating generic versions of  the medicine during this time period. This RDP period is followed by two years of market exclusivity during which generics cannot be launched. A final one-year extension can be afforded if the original product gains approval for a new therapeutic use that brings significant clinical benefit. 
• The Commission proposed to reduce the baseline RDP period to six years with possible extensions available if the medicine satisfied certain conditions. The Parliament increased this baseline period to 7.5 years in its position but also proposed that the overall RDP period be capped at 8.5 years. The Council opposes these proposed reductions and instead proposes to maintain the current period of eight years. The Council proposes to remove any potential modulation to the RDP period adopted in the Commission and Parliament’s respective positions and instead applies this modulation to the market exclusivity period. The Council proposes halving the current baseline market exclusivity period from two years to one year, with potential extensions up to three years if the product meets certain criteria.  

Orphan medicines  

• The Council opposes the Commission and Parliament’s proposed reduction of the market exclusivity period for orphan products to nine years and instead proposes that the period of ten years contained in the current regime, is retained. 
• The Council agrees with the Commission’s original proposal to grant a prolongation of 12 months to the market exclusivity period for orphan products if the authorisation holder obtains authorisation for a new therapeutic indication for a different orphan condition. This extension may be granted up to two times if each new therapeutic indication is for a different orphan condition i.e. up to a maximum market exclusivity period of 12 years. Although an orphan product which satisfies this test will obtain a prolongation, it will not benefit from the additional one year of RDP discussed above. 

Access and availability  

• In order to enhance availability of medicines, the Commission proposed to promote continuous supply of products through providing market authorisation holders with an extension of the RDP period by two years where they continuously supplied the product in a sufficient quantity to meet the needs of patients in every Member State in which the market authorisation was valid before the expiry of a specified time period. Parliament proposed to de-link this requirement from access to any additional RDP and instead proposed to introduce financial penalties for any MA holder  who failed to comply with a request from a Member State to submit a reimbursement application and subsequently supply the authorised medicine in that Member State.  
• The Council’s position proposes a compromise between the Commission and Parliament’s distinct positions,  under which a Member State, within one year of the MA being granted, may request the MA holder to place a product on the market and supply it in sufficient quantities to meet the needs of patients in that Member State, as specified by that Member State. The Council removes express reference to imposition of any financial penalties for non-compliance but does provide that, if the MA holder does not comply with the Member State’s request within four years of the MA being granted, the market exclusivity period (and any extension of same) will not apply to the authorised medicine  in that Member State. 

Transfer exclusivity voucher  

• The Council supports the introduction of a transferable exclusivity voucher for priority antimicrobials contained in the Commission’s proposal. This provides the holder of the voucher with an additional year of RDP for the priority antimicrobial or another authorised product of the same or a different MA holder.  
• The Council has included an additional requirement that, in order to be granted a voucher, the applicant must demonstrate that the MA was first applied for in the EU or was submitted no later than 90 days after the applying for the first MA outside of the EU. The Council also suggests that the voucher be transferrable at any time before its use. 

Next steps 

The Commission, the  Parliament and the Council must now aim to agree on a final text for the two proposed pieces of legislation. Following the first trilogue, technical meetings and a second trilogue are expected under the Danish Presidency of the Council, which commences on 1 July. Whilst still a work in progress, political agreement would now seem to be within relative touching distance.

The reforms are due to enter into force on the twentieth day following their publication in the Official Journal of the European Union, which would happen after that agreement is reached. The Council proposes that the EU Pharma Package applies 36 months after its entry into force, an increase from the 18 months previously proposed by the Commission.  

Thanks to Stephanie Breen for her assistance with this piece. 

For more information, please contact our Life Sciences Group.