Life sciences sector plan
The government published its life sciences sector plan in July 2025. It is a comprehensive document which, for the first time ever, includes specific policy goals for the off-patent sector. This includes a stated desire to become a world leader in the uptake of off-patent medicines. We support this ambition and are working with government colleagues to realise tangible outcomes.
Progress
Since the sector plan was published, progress has stalled in terms of implementation. This is in large part caused by the renegotiation of the VPAG pricing scheme. Now that it is concluded, it is critical that further delays in rolling out the sector plan do not occur.
Life sciences can be a catalyst for broader economic growth, and the sector plan provides a pragmatic blueprint to accelerate investment. Medicines UK looks forward to working with government colleagues to bring to life the ambitions of the sector plan.
Oversight
The Life Sciences Sector Plan is a flagship Government document. It aims to drive growth, innovation and better health outcomes. Below we track the pledges made in the plan which are particularly relevant to the off-patent sector, and set out what more remains to be done.
| Category | Pledge | Page | What has been achieved? | What remains to be done? | Status |
| MHRA | Boosting support for the MHRA with more investment to enable them to deliver a risk-proportionate and predictable service to users, which adheres to statutory timelines (with a clear ambition to exceed statutory timeframes. | 34 | Licensing backlogs have been removed and performance is steadily improving. 30% increase in generic new product application volume. MHRA maintaining performance. | In the EU, the EMA is reducing approvals times from 210 to 180 days. The MHRA needs to at least match this. By 2028 MHRA should reduce their statutory time from 210 to 170 days, with 150 days (as now) for innovative medicines. But overall we are seeing the MHRA's best performance for a decade. | |
| MHRA | Deliver the MHRA’s digital transformation at pace, so that from 2026 their digital platforms far better support industry applications and enquiries | 34 | Programme stopped in Nov 25 after delays | Restart programme and deliver | |
| MHRA | The MHRA will continue to work with industry through the Electronic Patient Information (EPI) taskforce to explore how the UK can use new technological approaches to move to user-centred, digital-first information that is inclusive and accessible | 35 | Improving Patient Information project set up; it has undertaken user research and stakeholder engagement and published a three-year project plan | Need to see project implemented, hopefully at a faster pace than set out in the project plan | |
| MHRA | Use international reliance and recognition routes for medicines and medical devices, to streamline the route to market for products which have previously sought Comparator Regulator approval, to enable a focus on getting cutting-edge and transformative products to patients. DHSC will introduce a pre-market statutory instrument, including the International Reliance Framework, to Parliament, by Autumn 2026. | 34 | International Recognition Process from EU is working well with approvals in 3 months | This has not been implemented for the US or Canada. There needs to be clarity about whether the Government is still seeking this. | |
| NICE | Implement reforms so that NICE processes encourage biosimilar and high-value generic reappraisals that open up access to medicines to a wider patient cohort. | 37 | Programme of work committed to by NICE but few details yet | Design and implement reforms | |
| NICE | Expanding dynamic assessments of priority care pathways to give clinicians clarity on the most clinically and cost-effective care. NICE will improve patient outcomes and maximise the value of innovations by keeping guidance in priority clinical areas up to date as new evidence emerges | 35 | NICE is in the process of considering how to work towards ongoing prescribing guidance for priority treatment pathways. | Implement this, and link with the Single National Formulary | |
| NHS and biosimilars | Introducing a Single National Formulary to remove bureaucratic delays to patient access, reduce unwarranted variation in prescribing, and free-up healthcare staff administrative time to focus on caring for patients. We will work with industry throughout its implementation | 37 | NHSE and OLS is working with industry on the implementation of the SNF | The SNF must be implemented in such a way that doesn’t create supply challenges, nor acts as a bottleneck for companies developing off-patent products that offer incremental innovation. | |
| NHS and biosimilars | Harnessing the opportunities offered by the Procurement Act (2023) to be able to give earlier sight of NHS tenders for suppliers. | 40 | NHSE is planning to provide longer lead times following award notification for biosimilars (6 months) and generics (minimum 20 weeks) | To implement and transition to these timescales over the course of 2026 | |
| NHS and biosimilars | Driving early and widespread uptake of new biosimilars, by working with local healthcare systems on implementation plans to ensure that switching is introduced as soon as clinically appropriate, and to reduce variation at the local level. | 37 | This is occurring, with NHSE central support. Aflibercept has 60% biosimilar uptake in 3 months. A joint programme with Medicines UK to boost biosimilar uptake has just been completed. | Ensure utilisation of biosimilars can continue without need for time-intensive centralised co-ordination of switching. Deliver new knowledge and information toolkit for clinician and patient engagement | |
| NHS and biosimilars | Continue to refine the implementation of the NHS Net Zero Roadmap. We will work towards appropriate and clarified measurement processes, so that the NHS and firms work in partnership towards net zero while ensuring no undue burden is placed on firms. | 30 | NHS England has begun engagement with industry on what its 2028 milestone of introducing some kind of product-level carbon footprinting will look like in practice | NHS England needs to ensure its 2028 requirements are proportionate and practicable for companies with very large product portfolios. | |
| International | Address how we will approach renewing relationships with the US and EU and prioritise how we engage with other markets, informed by the sector, and leveraging a whole-of-government approach to growth in key markets | 43 | 0% US import tariffs were secured (although ongoing status is somewhat unclear) | Secure mutual recognition of batch testing and testing with EU. Make argument that UK production should be considered on a par to production in EFTA under the EU draft Critical Medicines Act. Implement EU Pharma Review in Northern Ireland in a way that protects supply. | |
| International | Using all our international dialogues, partnerships, and agreements, we will champion strong international regulatory cooperation and harmonisation. We will use all levers, including our Mutual Recognition Agreements and bilateral engagement between regulators. The latter will be supported by the newly announced Ricardo Fund, which will provide backing for UK regulators, expert bodies, and our overseas trade teams to open up and shape priority growth markets, across frontier sectors | 44 | The UK Government and India have tentatively agreed to mutual recognition of decisions by 2030. | This commitment needs to be publicly confirmed. | |
| International | Multilaterally, we will support the vital work of preparing for future health emergencies. We will promote the role of regulatory cooperation in facilitating trade and continue to reduce unnecessary trade barriers in health | 44 | The UK Government has stepped up its scenario planning and has published a considered supply resilience strategy that it is now implementing with the supply chain. | A financially sustainable community pharmacy agreement needs to be agreed as a priority. Greater clarity on the regulatory flexibility routes available in emergencies for industry to utilise. | |
| International | On IP, we will encourage trading partners to raise their IP standards to those of the UK. | 44 | Ensure any Swiss agreements maintain UK standards not theirs | ||
| Manufacturing, championing innovation and supporting promising UK companies | Deliver the £520 million the Life Sciences Innovative Manufacturing Fund. | 8, 30 | Funds continue to be awarded. | Review how to ensure the Fund is attractive as possible, in view of EU and US efforts to secure production | |
| Manufacturing, championing innovation and supporting promising UK companies | Establish Regional Health Innovation ‘Zones’ for large scale development and implementation of innovation, for scale-up across the health and care system. | 39 | Clarify the role of the off-patent sector, which can establish innovative delivery models at scale, working with partners like community pharmacy. | ||
| Manufacturing, championing innovation and supporting promising UK companies | Establish a dedicated service to support 10-20 high-potential UK companies to scale, invest, and remain domiciled in the UK | 8 | |||
| Manufacturing, championing innovation and supporting promising UK companies | Place a growth mandate on NHS commercial activity including NHS Supply Chain, and within the Medicines Procurement and Supply Chain Frameworks. This will drive focus on activity which is growth-maximising, and ensure that promoting innovation is seen as an institutional objective, alongside achieving value for money. | 39 | Project Revive willing to use price to support broader objectives and be creative about getting medicines in. VBP reforms proceeding | Encourage development of ready to use market with NHS trusts, which while more costly in acquisition cost, can provide multi-faceted patient, staff, productivity and environmental benefits. |
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