Earlier this month, the Association of the British Pharmaceutical Industry (ABPI) launched their "ABPI manifesto for investment, health and growth", setting out its key "asks" of the UK Government in order to bolster the country's position on the global stage when it comes to research and development, and access to medicines.
Who are the ABPI?
The ABPI is the trade body, recognised by the Government, that represents both medicine-producing and research-based pharmaceutical companies in the UK. The ABPI speaks for the interests of these companies during statutory consultations on the pricing scheme for branded medicines in the UK.
In addition, the ABPI maintains the ABPI Code of Practice which sets out standards with which pharmaceutical companies are expected to comply in their promotion of prescription medicines. The ABPI Code seeks to regulate pharmaceutical companies' interactions with health professionals whilst setting standards for the provision of prescription-only medicines to the public and patients. The Prescription Medicines Code of Practice Authority maintains overall responsibility for the ABPI Code (and operates independently of the ABPI).
On behalf of the pharmaceutical industry, the ABPI plays an integral role in shaping healthcare policy and regulation in the UK.
The ABPI's manifesto sets out three main asks of the Government:
Ask 1: "Strengthen the development, regulation and adoption journey for new medicines and vaccines, making the UK a beacon for global research investment"
The first ask of the ABPI seeks to address the UK's post-pandemic decline in the number of clinical trials and remedy the lack of connectivity inherent in the UK's data infrastructure. The ABPI asserts that the UK must utilise innovative assets and attract the necessary expertise to encourage research investment. To do this, the Government needs to:
- streamline the approvals process when it comes to new medicines by in turn procuring better alignment between the Medicines and Healthcare products Regulatory Authority, health technology assessment bodies and the NHS to ensure medicines receive early regulatory approval.
- in collaboration with industry, academic and national funding organisations, put in place a long-term, sustainable public fund for research and development endeavours.
- put in practice Lord O'Shaughnessy's independent review of commercial clinical research to strengthen the UK's legitimacy as a leader in pharmaceutical research.
- set up a process by which to enrol patients on cutting edge clinical trials based on their genetic test results, paving the way for personalised medicines access.
- create a centralised health data recruitment service to give patients equal access (irrespective of their location) to commercial and non-commercial clinical trials.
- develop a "fit-for purpose" health data network that is easily accessible for researchers.
Ask 2: "Work with industry as a partner to drive better health, investing in medicines and vaccines to improve prevention and health equity and deliver a sustainable NHS"
This ask seeks to remedy the UK's poor patient outcomes, which is compounded by NHS staffing shortages and a general lack of swift access to new medicines. The Government ought therefore to:
- deliver on its commitments under the new "2024 Voluntary Scheme for Branded Medicines, Pricing, Access and Growth" (which replaced the "VPAS" in January this year), such as adopting new payment models for cell and gene therapies and reviewing the Commercial Medicines Framework.
- adopt the National Institute of Health's recommendation that the economic modelling tool used to assess the cost benefits of new medicines (the discount rate) better reflect those medicines that are the focus of current development (e.g., curative medicines), to give patients freer access to such.
- re-assess the criteria that patients need to satisfy in order to qualify for access to the Innovative Medicines Fund, thereby providing more individuals with access to non-oncological, innovative medicines.
- create a uniform approach to vaccine horizon scanning to avoid budgeting pressures and ensure that the UK is at the forefront when it comes to vaccine access and uptake.
- address the "silent pandemic" posed by anti-microbial resistance by establishing a central fund for the National Action Plan.
Ask 3: "Equip industry with the tools to drive UK economic growth, safeguarding intellectual property, removing trade barriers and incentivising advanced medicines manufacturing and skills development"
At present, the UK is falling short when it comes to attracting life sciences investment. To boost its competitive edge, the ABPI recommends that the Government:
- engage with the development of an international IP framework and champion the removal of medicine tariffs and export restrictions.
- prioritise life science exports as a key area of growth.
- address the skills deficit by reforming the apprenticeship levy; benchmarking UK visa costs, and setting up a collaborative taskforce comprised of representatives from the relevant industry bodies to facilitate an open forum with which to collaborate with the Government.
- commit to the proposed £520 million Capital Grants Programme for Life Sciences Manufacturing and deliver £200 million in funding towards the Innovative UK's Transforming Medicines Manufacturing Programme. This is in addition to the Government setting up a voluntary scheme investment programme.
- set up a national infrastructure programme to support market players in meeting their sustainability targets.
- provide internationally competitive tax and fiscal incentives to encourage research and development and capital investment.
Whether or not the Government will meet these requests remains to be seen, but addressing these asks will reinforce the UK's renown in the field of pharmaceutical research and development whilst improving patient outcomes – something which, amidst an NHS in turmoil, cannot come soon enough.