As readers will be aware, at the end of 2025, the EU institutions agreed the text of the EU Pharma Package: the wholesale change to the pharmaceutical regime in the EU that has been debated for many years. The changes introduce wide ranging amendments that impact rewards and exclusivities, supply chain set up, and procedures for generics and biosimilars. With the text of the new legislation due to be published shortly, questions are being asked about what this means for the legislative framework in the UK. The EU Pharma Package means divergence between the UK and EU is inevitable, and this is likely to have significant implications for the UK market.
Position in the UK
Following Brexit, the UK has been a freestanding regulatory regime separate from the EU. However, for a certain period, under the Northern Ireland (NI) Protocol, medicinal products on the market in NI continued to be subject to EU rules. This led to a complicated regulatory framework, with companies having to obtain separate licenses for Great Britain and NI. On January 1, 2025, new UK-wide arrangements came into effect, known as the “Windsor Framework,” which sought to ensure that medicines for supply in the UK can be authorized UK-wide by the Medicines and Healthcare products Regulatory Agency (MHRA) in accordance with UK law.
The changes introduced by the Windsor Framework apply to medicines that were formerly within the scope of the EU centralized procedure. However, this only applies to certain products on the UK market, and a large proportion of products continue to follow EU rules. Therefore, in practice, companies continue to face two sets of requirements depending on the type of product:
- Category 1 - Medicines that were previously within the mandatory or voluntary scope of the EU’s centralized procedure, and following the Windsor Framework, are regulated in line with UK law
- Category 2 - Medicines that do not meet the criteria for Category 1, and are authorized in accordance with UK law and applicable EU law
Given that the UK regulatory regime has been based on EU legislation for many years, post-Brexit, the difference between the regimes was primarily organizational and administrative, rather than (major) substantive differences between the applicable rules.
However, with the EU agreeing substantial reform of its regulatory regime, divergence will now increase.
Impact of the EU Pharma Package
Category 1 products are authorized in line with UK law, and so the changes to the EU legislation will not directly impact these products. However, in practice, many companies operate common systems for the UK and EU, and divergence will make this more difficult.
Further, the new EU regime will apply to Category 2 products on the market in the UK and so for these products, companies will need to apply both regimes.
The UK may decide to introduce similar changes to UK legislation that will apply to both Category 1 and Category 2 products or may pick and choose which amendments to adopt. However, even with the (anticipated) long transition period under the new EU regime, it is unlikely that the UK can finalize any changes to the UK legislation so that the changes can be introduced in parallel, even if it chooses to take this approach.
Divergence is therefore inevitable, which is likely to cause complications for companies, particularly for Category 2 products, such as the following:
- Protection periods: A key area of the EU Package is a reduction in the protection periods for innovative products, although with the ability to extend these if certain criteria apply. The UK may elect not to replicate these provisions, meaning the protection periods will be longer and more predictable in the UK. The UK therefore has the opportunity to position itself as pro-innovation by offering increased protection for products.
- Pediatric Investigation Plans (PIPs): The Package introduces changes to PIPs for medicinal products, seeking to make the requirements stricter, and by introducing an adapted PIP for certain products. Pediatric development is costly and time consuming for companies, and up to now, the MHRA has taken a pragmatic approach to recognizing PIPs agreed in the EU to reduce the additional burden on companies. If there are substantive differences in the requirements in the EU and UK, that pragmatism may become more difficult.
- Antimicrobials: Measures are being introduced in the EU to promote the prudent use of antimicrobials, such as the compulsory use of prescriptions. This could impact a range of products, such as those to treat thrush or athletes’ foot, which are currently available “over the counter” in the UK. It is currently unclear how the compulsory prescription will be implemented, but if this is a term of the marketing authorization of a Category 2 product, this may also impact supply in the UK.
- Product information: If there are changes to the requirements for product information, and the use of electronic information and QR codes, this could lead to different requirements in Great Britain and NI for Category 2 products, and cause difficulties for the supply of products across the UK. Different labelling requirements was a major difficulty under the NI Protocol, and a return to this administrative burden will not be welcomed by companies.
- Environmental risk assessment: The EU Package introduces changes to the environmental risk assessment, placing stronger obligations on companies to provide environmental risk data and propose risk‑mitigation measures. This will lead to different rules in the EU and UK and could lead to the need to prepare separate documents for the application dossier. It is also unclear whether these requirements will apply to Category 2 products, and if the MHRA will require submission of such documents in the UK.
- Generic and biosimilar entry: There are various changes in the Package aimed at streamlining and speeding up the launch of generic and biosimilar products. For example, there are changes to the data requirements and an expansion of the scope of the Bolar exemption. While these changes will not apply in the UK, it seems likely that these will impact the UK market, as data generated in the EU can be used in the UK. Further, there may be an impact on trials for generic products being undertaken in the UK if they can begin earlier in the EU.
Implications for Companies
For UK-based manufacturers, this dual framework may mean:
- Parallel filings may become more complex. This is likely to increase regulatory burden for companies as well as increase the need for internal resources to address these requirements. In particular, the contents of the application dossier are likely to be different in the EU and UK, which may delay submission in the UK.
- Portfolio planning will need to reflect UK-specific exclusivity periods. This may be a benefit if the UK can position itself as pro-innovation, but the size of the market compared to the EU may limit this impact.
- International Recognition should still operate in the UK, although the approach of the UK to the recognition of authorization after the EU changes are implemented will need to be monitored.
- Divergence is likely to continue as the EU regime develops further and the large number of additional legislation and guidance is published. Companies will need to maintain awareness of these changes and seek to engage with industry bodies and consultations on both sides of the Channel to try to ensure disruption is minimized. Importantly, given the different categories of products in the UK, companies will need to undertake a product-by-product assessment of the impact and may need to implement different strategies across their portfolio.
The UK government is expected to coordinate with industry bodies about the changes in the EU and what this means for industry. As with the Brexit negotiations and Windsor Framework, it will be important for industry to work with the government to ensure understanding of how the dual regime will impact products, companies, and patients. However, this may also be an opportunity to make targeted changes to the UK regime and enhance the UK position as a pro-innovation environment.