Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what steps he is taking to improve the (a) transparency of publicly-funded medical research and development and (b) accessibility and affordability of medicines developed from public research.

Research can only improve the lives of people or the wider United Kingdom economy if it can be accessed. A culture of openness also improves the quality and relevance of the research we support.

The National Institute for Health Research (NIHR) is funded through the Department to improve the health and wealth of the nation through research. The NIHR invests over £1 billion into health and public health research and is committed to “adding value in research” by maximizing the potential impact of research that it funds for patients and the public. This means ensuring that it answers the right questions (including effectiveness and cost effectiveness of interventions), delivers research efficiently and publishes results in full in an accessible and unbiased way.

Full and open access to the knowledge generated by research is of the utmost importance to the NIHR. Our commitment to transparency, our NIHR Journals Library, open access policy, and our endorsement of the World Health Organization joint statement on the disclosure of results ensures that ideas and knowledge derived from publicly funded research are made available and accessible for public use.

The Government works to improve accessibility and affordability of medicines, whether funded through public research or in the private sector, through a number of activities involving a range of parties.

The Health Service Medical Supplies (Costs) Act 2017 (the Act) amends the NHS Act 2006 to:

- Put beyond doubt that the Secretary of State can require companies in the statutory scheme to make payments to control the cost of health service medicines;

- Enable the Secretary of State to require companies to reduce the price of an unbranded generic medicine, or to impose other controls on that company’s unbranded medicine, even if the company is in the voluntary scheme, currently the Pharmaceutical Price Regulation Scheme 2014, for their branded medicines; and

- Enable the Secretary of State to make regulations to obtain information on sales and purchases of health service products from all parts of the supply chain, from manufacturer to pharmacy, for defined purposes.

The Government will respond shortly to the Accelerated Access Review (AAR). The AAR made recommendations to get transformative drugs and treatments to patients faster whilst ensuring the National Health Service gets value for money and remains at the forefront of innovation.

The National Institute for Health and Care Excellence (NICE) technology appraisal guidance and the associated funding requirement plays an important role in ensuring that patients have access to cost-effective new medicines, including medicines developed from public research.

The NIHR provides support for the development of new medicines, primarily through its investment in early translational research infrastructure in the NHS and through a range of research funding programmes.

The funding provided for the NIHR research infrastructure provides the expertise and facilities the NHS needs for first-class research, which health and life sciences industry researchers can access at any stage of the clinical development process. This helps drive faster translation of basic science discoveries into tangible benefits, for patients and the health system and has been specifically designed to close the gaps in translation identified in the Cooksey review in 2006.

All NIHR research infrastructure actively supports contract and collaborative research with the life sciences industry, and supports the commercialisation of new research and related technologies, including through spin-outs and licensing arrangements. This supports the translation of new medicines and helps grow new companies (including small and medium-sized enterprises (SMEs)). This helps ensure the UK remains one of the best places to develop and launch innovative medicines, technologies and diagnostics, benefitting patients and the health system.

NIHR research programmes generate high quality evidence on the effectiveness and cost-effectiveness of medicines for the NHS and public health services, including informing NICE guidance. The NIHR funds a number of programmes, of which The Health Technology Assessment programme is the largest. It funds independent research about the effectiveness, costs and broader impact of healthcare treatments and tests for those who plan, provide or receive care in the NHS. The NIHR also funds the Invention for Innovation (i4i) Programme that supports collaborative research and development projects in medtech SMEs, universities and the NHS on the development of innovative medical technologies by de-risking early stage projects that have a strong potential for acceptance for use in the NHS, as well as make them attractive to follow-on funders and investors.

The NIHR Innovation Observatory (NIHRIO) applies state-of-the-art data analytics to explore trends in health innovation across drugs, medical technologies, diagnostic tools and healthcare services. Using digital tools, NIHRIO appraises and supplies timely information to stakeholders including the Department, policymakers, academia and industry, so that developments leading to better and more cost effective healthcare can be identified.

The Department is also working alongside the Association of Medical Research Charities and a number of their members to look at how information from medical research into medicines can be translated more systematically to marketing authorisations and into patient care.