How manufacturers of generics and biosimilars can adapt to EU pharma law changes

The reforms could expose the off-patent industry to new risks – but holistic consideration of regulatory, intellectual property (IP) and commercial issues can help manufacturers free the way to pursue opportunities in the EU market.

Below, we explore some of the changes manufacturers of generic and biosimilar medicines will need to factor into their strategies once the reforms take effect.

A brief overview and adoption timeline

The EU’s general pharma legislation is more than 20 years old. In 2023, the European Commission proposed a package of changes, motivated by a desire to improve – and speed up – patient access to new treatments while balancing support for innovation and competition.

The Commission’s proposals have subsequently been the subject of scrutiny from EU law makers within the European Parliament and Council of Ministers. Both institutions must agree on the wording, and then vote to formally adopt the changes, for the reforms to be written into EU law.

Late last year, the Parliament and Council reached provisional agreement on the package. It includes a new regulation, which will have direct effect across the EU when adopted, and new directive, which EU countries will need to implement into national frameworks.

Neither the Parliament nor the Council have yet voted on the package – that is expected to happen later this spring or early summer. Most of the reforms would take effect two years after the legislative texts enter into force, so likely summer 2028.

Revamp of the Bolar exemption

Existing EU pharma law enables medicines manufacturers to use patented products or those covered by a supplementary protection certificate (SPC) when developing medicines for the purposes of obtaining marketing authorisation. This exemption from infringement is referred to as the Bolar exemption, named after the US ruling it originates from. However, EU countries have adopted different approaches when implementing the Bolar exemption.

Under the deal that the Parliament and Council have struck, the scope of the Bolar exemption would not only be clarified but expanded to cover a wider range of pre-launch activities.

The revised exemption will cover the necessary studies, trials and other activities conducted for the purposes of:

• obtaining marketing authorisation, including subsequent variations;
• conducting health technology assessments;
• obtaining pricing and reimbursement approval;
• complying with subsequent practical requirements related to the aforementioned activities;
• submitting an application on procurement tenders, to the extent that it does not entail the sale or offering for sale or marketing of the medicinal product concerned during the protection period provided by patent rights or SPC.

The changes will formally codify a patent linkage ban, meaning EU regulators will not be able to make their approvals for new generics or biosimilars conditional on the patent status of originator products.

The express inclusion of tendering within the exemption is an acknowledgement of market reality, but tender participation can readily be characterised as “offering for sale” or “marketing”, especially where pricing information is required and may already affect the originator’s market position before patent expiry. Without clear EU law definition of those terms stating otherwise, this part of the new exemption may have limited utility.

Actions manufacturers can take

Manufacturers of generics and biosimilars should assess how each EU country approaches the revised Bolar exemption, and specifically the tender participation limb of it. They should consider stress-testing launch and tender strategies against likely IP enforcement scenarios and ensure they obtain coordinated regulatory and IP advice to reduce pre‑launch litigation risk.

Incentives and regulatory data protection 

Regulatory data protection is one of a suite of measures provided for in EU law aimed at incentivising investment in drug research and development.

Currently, the period of regulatory data protection that applies lasts for eight years from the point marketing authorisation is granted. During this period, competitors – such as manufacturers of generics and biosimilars – are precluded from exploiting data the originators submitted to regulators, in the process of satisfying requirements for marketing authorisation, to develop their own products.

A two-year market protection period provides a further period of exclusivity on top of the period of regulatory data protection, during which time generic medicines manufacturers can obtain a marketing authorisation but their products cannot be placed on the market.

Under the pharma law revamp, this system of protections will change – the eight-year period of regulatory data protection is being retained but there will be just a one-year period of baseline market protection period. Balancing against this is the scope for originators to obtain multiple one-year extensions to these baseline protections – if they satisfy certain conditions.

The changes make the incentive system more complex and modular, making competitive intelligence and forecasting more challenging for manufacturers of generic and biosimilar medicines. Even though regulatory authorities will be expected to publish information on applicable protection periods and extensions in medicinal product registers, this may not sufficiently deliver the commercially relevant foresight required for long‑term lifecycle and launch planning.

The extensions that originators can obtain to baseline protections depend, to an extent, on business choices within their own discretion, including where to carry out clinical trials or where they file applications for marketing authorisation. For manufacturers of generics and biosimilars, this reduces predictability when seeking to develop off‑patent strategies.

A further challenge arises around the introduction of transferable exclusivity vouchers that manufacturers of ‘priority’ antimicrobials will be eligible for under the new regulation. Such vouchers can be used to extend the regulatory data protection period applicable to certain other medicines in that manufacturer’s portfolio – though not blockbuster products – by another year, provided that is triggered in either the fifth or sixth year of regulatory data protection applicable to the product the voucher is being transferred to. For manufacturers of generics and biosimilars, transferability adds a further layer of strategic uncertainty, particularly in late‑stage development planning.

Under the revamped package, repurposed medicines – i.e. products with a known active substance that are authorised for a new therapeutic indication – will also be eligible for regulatory data protection for four years. This will apply where the product is authorised via an abridged application and has not previously benefited from such protection, or where 25 years have elapsed since the grant of the initial marketing authorisation.

This provision is intended to encourage investment in clinically meaningful repurposing of well‑known substances, while limiting the impact on competition by capping the duration of protection, and excluding products that have already benefited from regulatory data protection unless they are sufficiently old. Products previously considered free of protection may acquire new, indication‑specific data exclusivity.

Actions manufacturers can take

The changes to the EU’s system of protections and incentives puts a greater onus on the integration of regulatory data protection analysis into broader portfolio and launch planning for generics and biosimilars. It will be important to monitor trigger points that may affect exclusivity duration.

The alignment of regulatory intelligence with IP expiry and launch timelines will be vital. Obtaining specific advice on indication‑specific launch strategies is also recommended.

Carve-outs to product information requirements

EU pharma law currently requires medicines manufacturers to provide regulators with a summary of product characteristics alongside applications for marketing authorisation that they submit. However, the exceptions to this are extended in the proposed legislative revamp.

Where current legislation allows carve‑outs only for indications or dosage forms, under the plans generic and biosimilar manufacturers will be able to carve out therapeutic indications; dosages; pharmaceutical forms; methods or routes of administration, and other uses that are still covered by a patent or SPC, provided that all relevant safety information related to the safe use of the medicinal product remains included.

This change reflects the emerging practice of national regulators – including in the Netherlands and Sweden – towards carve-outs to the product information requirements, holding that carve‑outs may apply to patent‑protected alternative methods of administration when interpreted in light of the context and purpose of the regulation. However, the requirement to retain safety information could increase generic and biosimilar manufacturers’ exposure to innovator patent challenges and it seems likely that disputes around carve‑outs will be resolved through litigation rather than regulatory processes.

Actions manufacturers can take

Generic and biosimilar manufacturers should design robust carve‑out strategies that balance regulatory compliance and IP risk. Regulatory submissions should be coordinated and strategies prepared for responding to litigation where carve‑outs are likely to be challenged.