UK Archives - European Industrial Pharmacists Group (EIPG)

Home  /  The UK’s statutory scheme revision for branded medicines  /  UK

A new member within EIPG


The European Industrial Pharmacists Group (EIPG) is pleased to announce the Romanian Association (AFFI) as its newest member following the annual General Assembly of EIPG in Rome (20th-21st April 2024). Commenting on the continued growth of EIPG’s membership, EIPG President Read more

The EU Parliament voted its position on the Unitary SPC


by Giuliana Miglierini The intersecting pathways of revision of the pharmaceutical and intellectual property legislations recently marked the adoption of the EU Parliament’s position on the new unitary Supplementary Protection Certificate (SPC) system, parallel to the recast of the current Read more

Reform of pharma legislation: the debate on regulatory data protection


by Giuliana Miglierini As the definition of the final contents of many new pieces of the overall revision of the pharmaceutical legislation is approaching, many voices commented the possible impact the new scheme for regulatory data protection (RDP) may have Read more

•••

The UK’s statutory scheme revision for branded medicines

October 20, 2023 , , , , , , , , , , , , , , , , , , , , , , , , ,

by Giuliana Miglierini

The amendment of the statutory schemeregulating the increase in pricing and consequent clawback payments of branded medicines proposed by the Department of Health and Social Care (DHSC) of UK’s government attracted the strong criticism of the pharmaceutical industry. The proposal aims to supersede the current scheme, established in 2018 by The Branded Health Service Medicines (Costs) Regulations. UK’s framework for pricing and clawback payments is completed by the 2019 voluntary scheme for branded medicines pricing and access (VPAS). Under the current framework, should a pharmaceutical company decide to opt out and not to join the voluntary scheme, then it becomes automatically subject to the statutory one. The current VPAS scheme, which in its original form dates to 1957, will end in December 2023. The DHSC is thus negotiating a new deal with the industrial counterparts to be effective starting 1 January 2024. Negotiations on the voluntary scheme are independent from the consultation on the statutory scheme, claims the DHSC.

The main features of the proposal

The statutory and voluntary schemes are administered by the DHSC on behalf of England, Wales, Scotland and Northern Ireland. The so received clawback payments from the pharmaceutical industry are then annually back allocated to each of the four countries on an agreed basis. According to the DHSC’s proposal, the ongoing negotiation should result in the two schemes – statutory and voluntary – continuing to operate in a complementary way. Should the negotiation on the voluntary scheme close without results, then the statutory scheme would continue to apply from 2024 onwards to all branded medicinal products. “With negotiations ongoing, there cannot currently be a default assumption of continuing alignment with any potential voluntary scheme provisions”, wrote the government. The proposed reform of the statutory scheme is comprehensive of an increase of the allowed annual growth rate, which is expected to impact on the back payment percentages. A revision of current exemptions from scheme payments should also occur.

A structure similar to that of the current statutory scheme should be used to manage these amendments, while a new lifecycle adjustment should be put in place to rebalance the payment percentages referred to medicines at different stages of their product lifecycle. As for unbranded biological products, which should be always prescribed by brand name according to MHRA’s guidance, the government aims to clarify that the statutory scheme should be applied to all biological medicines, irrespective to the fact they are marketed or not under a brand name. The government’s goal is to achieve a balance between these three objectives, “in a way that is consistent with supporting both the life sciences sector and broader economy”.

Comments from the ABPI

According to the Association of British Pharmaceutical Industries (ABPI), there is no equivalent in the world to UK’s voluntary scheme. The version agreed for the period 2018-2023 is based on a 2% per annum rise in pricing: pharmaceutical companies are called to pay back to the NHS rebates on their sales on all expenditure above the capped limit. On their side, the current voluntary scheme also requires the DHSC and NHS England to improve medicines access environment over the period 2019-2023.

ABPI mentions the dramatic rise in payments linked to the unforeseen circumstances of increased post pandemic NHS demand, which is posing major challenges for the UK life science sector. The members of the association more specifically criticise the cap growth mechanism, as well as the proposed lifecycle adjustment. The top management of leading pharma companies operating in the UK also expressed their views (read more, on the European Pharmaceutical Review).

More details on the proposals UK’s government confirmed its commitment to working with the pharmaceutical industry to facilitate the development of medicines in the UK and to support rapid NHS’s patients access to innovative medicines. The current form of the statutory scheme allows for a growth rate of 1.1% (nominal) per year for sales of branded medicines subject to the scheme. The payment percentage for 2023 and all subsequent years was set in April 2023 at 27.5%. The main exemptions refer to sales of pharmacy only and general sales list medicines, small companies with under £5 million sales to the NHS each year, sales of low-cost presentations costing less than £2, and parallel imports. The continuation of the policy of broad commercial equivalence between the statutory and voluntary schemes is the criterion chosen by the DHSC to protect the stability and efficacy of both: payment percentages in the statutory scheme would be thus comparable (but not necessarily identical) to those in the voluntary scheme. The new payment percentages in the statutory scheme proposed for 2024 would be based on a higher allowed growth rate of 2% (nominal). According to the DHSC, the maintenance of the current growth rate of 1.1% per year, in the absence of a newly agreed VPAS, would result in an effective decrease in allowed growth for most companies and might give rise to “a commercial environment for the life sciences sector that may not fully reflect the objective of supporting the sector and the broader economy”. On the other hand, an increase above 2% per year may lead to a unsustainable budget pressure on the NHS. As for the exemptions, the proposal aims to include in the statutory scheme some additional exemptions from payment which are currently part of the VPAS, namely referred to sales of medicines containing a new active substance (NAS) for 36 months from the date of their first marketing authorisation. According to the consultation document, this would incentivise companies to launch innovative medicines in the UK more rapidly than in other countries. An exemption from scheme payments for centrally procured vaccines (CPVs) is also part of the proposed package, and it would include vaccines for national immunisation programmes recommended by the Joint Committee on Vaccination and Immunisation (JCVI), procured by a central government body, or managed by the UK Health Security Agency (UKHSA) or a successor body. The third exemption to be included in the statutory scheme refers to payments for exceptional central procurements (ECPs). The measure would cover medicines related to purposes of emergency preparedness (i.e. national stockpiles) conducted by a central government body, or managed by UKHSA or a successor body. The lifecycle adjustment Innovative medicines are typically characterised by higher prices at launch, to then lower it while approaching the end of intellectual property protection. According to the DHSC’s proposal, initial prices are typically above the opportunity cost to the NHS, and older medicines would in general also benefit from greater price competition from generics and biosimilars. In some instances, states the document, this competition would be insufficient, thus resulting in prices not low enough to reflect the later stage in the product’s lifecycle. This especially applies to single supplier markets, where no competition at all is available. The proposal aims to overcome the current one-size-fits-all approach to the statutory scheme, and to introduce additional payments for older products with no competition, or a flat, lower payment for older products in more competitive markets. The so-generated additional income would then be used to reduce the headline payment percentage paid by newer products. According to the consultation document, these latter ones would refer to any product where the active substance has been marketed in the UK for less than 12 years.


UK will participate to European research programmes

September 29, 2023 , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

by Giuliana Miglierini

The divergent road opened as a consequence of the Brexit, in January 2021, between the European Union (EU) and the United Kingdom (UK) is now converging again as for the possibility for UK researchers to participate to Horizon Europe (HE) and Copernicus scientific programmes. The agreement in principle reached on 7 September 2023 by the European Commission and the UK Government was facilitated by the previous Windsor Framework Agreement. It shall now be ratified by the Council of the European Union, and then adopted by the Specialised Committee on Participation in Union Programmes.

“The EU and UK are key strategic partners and allies, and today’s agreement proves that point. We will continue to be at the forefront of global science and research.”, said the Presi-dent of the European Commission, Ursula von der Leyen.

The possible association of the UK to Horizon Europe animated a vigorous debate in the past couple of years among the scientific international community, as well as that of other third countries such as Switzerland (those association is still pending, see below).

The current agreements in place between the UK and the EU are not comprehensive of the participation of UK’s students to the Erasmus+ programme, participation that was cancelled by the UK government in 2020.

The financial terms of the agreement

The new association of UK to both HE and Copernicus programmes will become operative star-ting 1 January 2024, superseding the previous transitional agreement that allowed UK researchers to apply and be evaluated as other potential beneficiaries under HE calls. It will become possible for UK researcher to access HE’s 2024 Funding Programme and Work Programme (including the coordination of consortia), and to participate in the European Research Council and Marie Skłodowska-Curie Actions.

According to the European Commission, the estimated annual contribution of the UK to Horizon Europe and the Copernicus component of the Space programme should be on average €2.6 billion, in line with the terms agreed in the Trade and Cooperation Agreement. The EU Commission will issue twice a year a call for funds to the UK corresponding to the due contribution. The overall EU budget for Horizon Europe is €95.5 billion, plus contributions due by the various associated countries.

The agreement is also comprehensive of a correction mechanism referred to Horizon Europe, aimed to compensate the contribution of the UK, should its receipts in grants be higher than its contribution for grants. Under the terms of the Trade and Cooperation Agreement, an automatic correction to the UK’s contribution would occur if it reached a threshold of 8% over two successive years. A balance mechanism has also been put in place to compensate for the UK receiving significantly fewer grants than its contribution. In this instance, the level of UK participation may be improved, or (should it overpays by more than 12%), the issue may be object to scrutiny by the joint Specialised Committee on Participation in Union Programmes to agree upon the measures needed to balance the situation.

A temporary and automatic mechanism has been also agreed to address any risk of critical underperformance by the UK should the imbalance exceed 16%, based on the consideration the country did not fully participate in HE in the past two years.

The main fields of collaboration

UK’s participation to European research programmes will focus on area of mutual interest, i.e. emerging technologies, climate change and health. The participation to strategic parts of Horizon Europe – including those related to strategic assets, interests, autonomy or security – is subject to the previous assessment of UK participants on equal terms with other associated countries (Art. 22(5) of the Horizon Europe Regulation). The participation to other parts of HE will occur on equal terms with researchers and organisations from EU Member States.

Copernicus is part of the European space programme. The association will allow the UK to access a state-of-the art capacity to monitor the Earth and its services. Among the main goals of the programme is the understanding and acting on environmental and climate change related challenges. The UK will also have access to EU Space Surveillance and Tracking services.

The reactions

The announcement of the agreement on the association of the UK to European research pro-grammes found very positive reactions among the different parties interested in solving the issue.

“Joining the Horizon Europe programme is a huge win for the scientific research community, who have been pushing for resolution over the past few years. UK innovation and research de-pends on international collaborations which are crucial for driving advancements in all areas of science, including the discovery and early development of new medicines and vaccines”, said Janet Valentine, ABPI Executive Director, Innovation and Research Policy. “The UK accession to Horizon enables the two sides to reinvigorate their longstanding partnership in R&D, and directly contributes to UK growth and competitiveness in the life sciences sector by making the UK an attractive destination for talented researchers.”

“This decision represents a long-awaited signal for renewed international collaboration on fundamental frontier research in Europe. It will strengthen the research of all involved, both in the EU and in the UK. At the ERC, we look forward to welcoming back researchers based in the UK, after the trying last few years. They have been sorely missed, and will now be able to participate again as from our 2024 grant competitions”, said the President of the ERC, Maria Leptin.

The academic world represented by Cesaer highlighted the reintegration of UK into Horizon Eu-rope and Copernicus reaffirms the commitment of both the EU and the UK to advancing global scientific excellence. The association of the European universities of science and technology also supports further progress in building a wider international scientific community, with particular reference to Switzerland.

“Today, Europe’s universities celebrate the end of a long road that began in 2016 and look for-ward to rebuilding and further developing close partnerships” said Josep M. Garrell, President of the European Universities Association.

“We are extremely grateful for the efforts of everyone in the European research community who has worked tirelessly to help secure this agreement”, added Jamie Arrowsmith, Director of Universities UK International.

Switzerland is still waiting for the association

Despite Switzerland being a very important country for research in life sciences, and location of many of the major pharmaceutical industries, the country is still waiting to restart the negotiations with the EU for its association to the European research programmes. The exclusion of Switzerland from any form of collaboration was the result, in 2021, of the political divergence with the EU on many issues.

“We feel alone in the middle of Europe,” Yves Flückiger, rector of the University of Geneva, told Business|Europe.

According to the article by David Matthews, the incumbent Swiss federal elections in October 2023 and the European elections of 2024 may slow down the negotiations on the new political relationship. The association of Switzerland to EU’s research programmes might then not occur before 2025. Some explanatory talks would be already ongoing, adds the article. Sympathy for researchers in Switzerland was expressed by the ERC President, Maria Leptin. “They are not alone in the sense they are loved by all the rest of us,” she said. “There is very high-level research being done in Switzerland, same as in the UK. We all want to be one group that competes at the same level and is evaluated by the same high-level panels.”


The Windsor Framework

March 3, 2023 , , , , , , , , , , ,

On 27 February 2023, UK Prime Minister Rishi Sunak and the European Commission President Ursula von der Leyen announced that agreement had been reached on changes to the operation of the Protocol on Ireland/Northern Ireland.

The Protocol has been in effect since 1 January 2021 requiring that all goods coming into Northern Ireland from Great Britain comply with EU regulations. The UK Government and EU Commission have both made proposals in relation to the operation of the Protocol over the last two years. One approach adopted by the UK Government was to introduce the Northern Ireland Protocol Bill on 13 June 2022 providing UK with power to make further changes to it. In response to the Bill being introduced, the European Commission announced it was proceeding with legal action against the UK. Since then, negotiations between the UK Government and the European Commission increased in intensity and this led to the announcement of the agreement called “Windsor Framework”. Part of the new Windsor Framework is a political declaration published by both parties which confirms that the UK Government will not be proceeding with the Northern Ireland Protocol Bill and that the European Commission will halt its legal proceedings relating to the Protocol against the UK.

The Framework (This publication is available at www.gov.uk/official-documents)

The original Protocol applied all EU rules and authorisation requirements for medicines, notwithstanding that medicine supply is an essential state function. This meant that for novel medicines, including innovative cancer drugs, it was the EMA, not the MHRA, which approved medicines for the Northern Ireland market. This failed to recognise or accommodate for the fact that the overwhelming flow of medicines to Northern Ireland is from Great Britain, with medicines provided for the UK market as a whole.

The EU made a series of changes to its rules last year to address some of these issues, addressing regulatory requirements which prevented medicines flows and supporting the MHRAs continued ability to authorise generic drugs under a single licence for the whole UK. This, combined with the UKs own Northern Ireland Medicines Authorisation Route (NIMAR), has ensured that medicines have continued to flow uninterrupted into Northern Ireland. But these arrangements were not a complete solution for the long-term and did not address the EMAs role in licensing novel medicines, leaving Northern Ireland exposed to divergence as UK and EU rules changed into the future.

This uncertainty, as well as the requirement for Northern Ireland drugs to meet various EU labelling requirements, risked discontinuations if firms were unwilling to maintain two sets of labels and packs for Great Britain and Northern Ireland. This was not a sustainable way forward and has been addressed by this deal.

Under the agreement, both UK and EU have listened to the needs of industry and the healthcare sector and secured an unprecedented settlement that provides a comprehensive carve-out from EU rules: fully safeguarding the supply of medicines from Great Britain into Northern Ireland, and once again asserting the primacy of UK regulation.

As a result, it will be for the MHRA to approve all drugs for the whole UK market. This will enable all types of medicines to be supplied in single packs, within UK supply chains, with a single licence for the whole UK. This will provide a long-term, durable basis for medicines supplies into Northern Ireland.

  • Specifically, the whole of the Falsified Medicines Directive has been disapplied for medicines supplied to Northern Ireland, ending the unnecessary situation in which – even with grace periods – wholesalers and pharmacies in Northern Ireland were expected to keep barcode scanners to check individual labels.
  • And for the provision of innovative drugs to patients, Northern Ireland will be reintegrated back into a UK-only regulatory environment, with the European Medicines Agency removed from having any role.
  • This responds to the overwhelming calls from industry for stability and certainty, and can give reassurance to patients and clinicians in Northern Ireland well into the future.

At the same time, the agreement safeguards frictionless access to the EU market for world-leading Northern Ireland pharmaceutical and medical technology firms. This pragmatic dual-regulatory system protects business, patients and healthcare services, and reflects that it is an essential state function to maintain and oversee the supply of medicines within the whole United Kingdom.

Proposal for a Regulation (This publication is available at EU commision website here)

The European Commission has published a proposal for a Regulation that in essence carves-out medicinal products destined for the UK internal market from the EU pharmaceutical rules. Article 4(1) of the proposed Regulation provides that centrally-authorised products cannot be placed on the market in Northern Ireland. Such medicines may be placed on the market in Northern Ireland if all the following conditions are met:

  • the competent authorities of the UK have authorised the placing on the market of the product in accordance with the law of the UK and under the terms of the authorisation granted by the competent authorities of the UK;
  • the medicinal product concerned shall bear an individual label which shall be attached to the packaging of the medicinal product in a conspicuous place in such a way as to be easily visible, clearly legible, and indelible; it shall not be in any way be hidden, obscured, detracted from, or interrupted by any other written or pictorial matter or any other intervening material. it shall state the following words: “UK only”.
  • the UK shall provide the European Commission with written guarantees that the placing on the market of the medicinal products does not increase the risk to public health in the internal market and that those medicinal products will not be moved to a Member State.

.

Sources:


EFPIA’s Annual Report on the Pharmaceutical industry 2022

September 9, 2022 , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

by Giuliana Miglierini

“In the 21 years from 2000 to 2021 – in which time we’ve come through the Global Financial Crisis and a pandemic – EFPIA companies have more than doubled production, increased exports by a factor of six, and recorded a trade balance that puts it far ahead of other high-tech sectors in Europe”, writes EFPIA’s Director General Nathalie Moll commenting the Annual Report2022.

Despite this marked growth, many challenges are still to be faced to allow the European pharmaceutical industry to maintain and even strengthen its role as primary hub of innovation, thus contributing to the overall success of the EU’s economy. It can be expected, for example, that the energy crisis will be highly impacting pharmaceutical productions, also in the form of increased difficulties to guarantee a constant supply of raw materials. This would represent just the last drop adding to existing regulatory barriers slowing down R&D and to the impact of fiscal austerity policies that may discourage investors.

“At the same time, we have seen the growth of Brazilian, Chinese and Indian markets outstrip growth in the top 5 European markets. Our global competitors have prioritised life sciences and we must respond with similar ambition”, adds Nathalie Moll.

The 2021 of the pharmaceutical industry

According to EFPIA’s Annual Report 2022, the value of production for the research-based European pharmaceutical industry has grown from 127.5 billion euro in year 2000 to 300 billion in2021. Even more relevant is the growth of export, increased from €90.9 bln to €565 bln over the same period. In 2021 imports counted for €390 bln, with a positive trade balance of €175 bln.

The research-based pharma industry employed last year 840,000 units (125,000 of which in R&D) and invested €41.5 bln in research and development activities.

The total European pharmaceutical market value at ex-factory prices increased from €89.4 bln in 2000 to €255 bln in 2021. The pharmaceutical expenditure supported by statutory health insurance systems (and referred to ambulatory care only) grown from €76.9 bln to €157.5 bln over the same time.

Despite these positive figures, EFPIA warns about the danger of migration of many R&D activities from Europe towards fast-growing markets such as Brazil, India and China, thanks to the more favourable conditions. The pharmaceutical market in these countries grown, respectively,11.7%, 6.7% and 11.8% in the period 2016-2021, compared to 5.8% of top EU countries (France, Germany, Italy, Spain and United Kingdom) and 5.6% of the US.

North America still represents the wider market area for pharmaceuticals (49.1%, vs 23.4% for Europe), and accounts for the higher proportion of new launches (64.4%, vs 16.8% of top five EU countries). In 2020 China marked the higher pharmaceutical R&D expenditure (78,5 billion Yuan, from 1.9 bln Yuan in 2000), overcoming for the first time the US ($72.4 bln), while Europe is positioned far behind (€39,7 bln). Not less interesting is the 3.2% market share assigned to emerging, high-growth pharmaceutical markets including many African, South American and Asiatic countries (Algeria, Argentina, Bangladesh, Brazil, Colombia, Chile, China, Egypt, India, Indonesia, Kazakhstan, Mexico, Nigeria, Pakistan, Philippines, Poland, Russia, Saudi Arabia, South Africa, Turkey and Vietnam).

Parallel trade is a characteristic of the European pharmaceutical market, due to the persistent fragmentation of many policies in different countries. Denmark saw in 2020 the higher share of parallel imports in pharmacy market sales (26.9%), well above other countries (e.g. 10.9% Sweden,9.1% UK, 8.3% Germany).

 Issues slowing down R&D

According to EFPIA, the length of time needed to bring a new medicine to the market (up to 12-13 years) is still a major issue impacting the attractiveness of European R&D. An average of one-two new synthetic substances out of every 10 thousand exiting the labs passes all the scrutiny steps needed to reach approval. The total costs of R&D was estimated in 2014 to reach €1.97 billion, indicates the report.

Germany, Switzerland and the UK are the European countries more active in research and development (€7.8 bln, €7.4 bln and € 5.6 bln expenditure in 2020, respectively). Clinical research accounts for the higher percentage of investment (44.1%, mainly in phase III studies), far above pre-human and pre-clinical research (14.9%) and phase IV studies aimed to post-marketing surveillance (11.5%). Approval studies account for 4.3% of the total R&D expenditure.

The US generated 159 new chemical entities (both chemical and biological) in years 2017-2021, almost doubling Europe (72) and a group of other countries (71), excluding Japan (41). Even more worrying, in 2021 China lagged just behind Europe as originator of new active substances launched for the first time on the world market (18 vs 19, respectively), while the US confirmed its leading position (35). According to EFPIA, this trend is associated with a marked lower annual growth rate of pharmaceutical R&D expenditure in Europe (4.0% for years 2017-2021), compared to that in the US (8.5%) and China (12.9%). Despite this, health industries still position at the first place of the ranking of industrial sectors by overall R&D intensity (12.4%, vs 8.7% of ITC services and 7.4% of ITC products).

The pharmaceutical production

Switzerland, Germany and Italy are the leading European hubs for pharmaceutical production (€53.2 bln, €32.3 bln and €34.3 bln of value, respectively). This corresponds in Germany to a significant higher number of people employed in the sector (115,519, vs 66,400 in Italy and 47,000 in Switzerland). EFPIA also mentions that the research-based pharmaceutical industry generates about three times more indirect employment along its value chain (both upstream and downstream) than it does directly, thus significantly contributing to the overall European job market. This is even more true for highly skilled jobs, thus preventing the phenomenon of brain-draining towards more attractive countries for scientific talents.

The US remains the favoured trading partner for the EU pharmaceutical industry, accounting for 32.2% EU exports and 30.2% imports. Switzerland is at the first place for EU imports (36.4%, and 11.8% EU exports); more distanced are the UK, China and Japan.

Fragmentation still impacts the European market

Fragmentation of policies on price and reimbursement and different VAT rates for medicinal product sis a very typical phenomenon still limiting the potentiality of the European pharmaceutical market.

According to EFPIA, in 2020 the retail price of a medicine corresponded on average to 66.8% rewarding for the manufacturer, 17.4% for the pharmacist, 10.6% for the State and 5.2% for the wholesaler. The top 5 countries for market value at ex-factory prices were Germany (€42.9 bln), Italy (€23.4 bln), France (€29, 5 bln), the UK (€24.6 bln) and Spain (€17.6 bln); Russia also represented a relevant market (€18,4 bln). Italy sees the higher market share for generics (67.6%), well above Poland (58%) and Austria (49%). EFPIA also monitored the VAT rates applied to prescription and OTC medicines in different European countries, compared to the standard VAT rates. Malta (0%), Sweden (0%), France (2.1%), Switzerland (2.5%), Luxembourg (3%), Spain (4%), Lithuania, Croatia, Cyprus, Hungary (5%) marked the lower VAT rates on prescription medicines. In some case, these same rates applies also to OTC products (Croatia, Cyprus, Hungary, Luxembourg, Malta, Spain, Switzerland), while in other countries the rates for this category of medicines is higher (France 10%, Lithuania 21%, Sweden 25%).


Horizon Europe Association – Statement on behalf of the European Health Stakeholder Group

December 10, 2021 , , ,

As representatives of the European Union’s health community, we are united in our call for the United Kingdom’s association to Horizon Europe to be formalised as soon as possible.

Horizon Europe aims to tackle the major global challenges of our time but achieving this aim will be impossible without international collaboration. The COVID-19 pandemic has clearly highlighted the critical value of global partnerships to advance scientific discovery and innovation, especially where speed is of the utmost importance. The depth and strength of successful international collaborations resulting from the relationships built up over many years with the UK is long established.

We have all reaped the mutual health benefits of these collaborations. Together, we have significantly advanced health care across Europe, saving and improving citizens’ lives. Clinical trials, particularly on diseases with limited patient populations, have been heavily reliant on EU-UK collaboration, while close research and innovation partnerships continue to accelerate life-changing medical research.

Going forward, we must continue to work together in order to meet the challenges of our swiftly changing world. Our ability to respond to the threat of climate change and outbreaks of new diseases like COVID-19 has been greatly improved by close scientific and clinical partnerships across Europe. Knowledge and discovery do not stop at borders: the shared global challenges we face require joint solutions. Collaboration through the research framework programmes is a springboard to productive partnerships across the world.

As a community, we welcomed the provision in Protocol I of the EU-UK Trade and Cooperation Agreement for the UK to associate to Horizon Europe. The subsequent Q&A document from the European Commission provided us with confirmation that we could apply with UK entities for the first multi-beneficiary calls. Based on these reassurances, EU health research organisations have been working with UK partners on the understanding that they would shortly become full associate members. However, the absence of a clear timeframe for formalising UK association is now causing increasing concern. We notice too with regret that while the specialised committees for other policy areas are already established, the Specialised Committee on Participation in Union Programmes has not yet even had its first meeting.

This continuing uncertainty risks jeopardising current and future research partnerships, and time is fast running out. With the first Horizon Europe grant agreements nearing finalisation and new calls expected imminently, UK association must be formalised. Now is the time to act. Further delays or the spectre of non-association would result in a missed opportunity to tackle the major challenges of our time, diminish our collective research capabilities and weaken Europe’s position in the highly competitive global market.

Many profound and long-lasting EU-UK research partnerships are at stake. These are of high value to Europe as a whole – and to the world at large. We owe it to future generations in the EU and beyond to ensure that the new EU-UK relationship best serves them through research.

We stand with our colleagues in the European Union’s research and innovation community in urging the European Commission to formalise the United Kingdom’s association to Horizon Europe without further delay.

The European Health Stakeholder Group

The joint statement in full can be found in the following versions: EN, FR and IT.