My Lords, first, I would like to address the issue of patient and clinician access to affordable medicines in the UK. Patient and clinician access to affordable medicines is at the core of the NHS and this country’s healthcare policy. This Bill will not diminish that. Indeed, a safe and innovative
regulatory regime for medicines and devices will support that outcome, although patient access is not dealt with directly in this Bill. The Government have recourse to a number of mechanisms to ensure that patient and clinician access to affordable medicines is upheld. For example, the price of branded medicines is controlled by the 2019 voluntary scheme for branded medicines pricing and access. The National Institute for Health and Care Excellence also continues to ensure cost-effectiveness for medicines purchased by the NHS.
As the noble Baroness, Lady Sheehan, has noted, in line with the flexibilities in the TRIPS agreement, the Government also retain the right to order Crown use of patented medicines under Section 55(1)(a) of the Patents Act, where collaborative approaches are not successful or we determine that it is in the public interest. I should emphasise that this would be used only in very narrow circumstances, such as an emergency. The UK has an internationally renowned IP system, which cultivates an innovative pharmaceutical sector, attracts generics manufacturers, and ensures that the NHS has access to the most cost-effective options. We will continue to work with these stakeholders to provide cost-effective access to Covid-19 therapies and vaccines, in the UK and globally, on a voluntary basis.
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I will answer the two questions put by the noble Baroness, Lady Sheehan, directly. On the question of Crown licences, if the Government deemed it necessary, we would make use of compulsory licensing or Crown use provisions, but we have made it clear to interested partners that we do not believe this is required at this point in time. The second question put by the noble Baroness was on whether the Government had carried out any review into the efficacy of the patent system to incentivise research and development into vaccines, therapeutics and health technologies. In 2011 a review by Professor Ian Hargreaves into the UK’s IP system was commissioned, to look at whether it was sufficiently well designed to promote innovation and economic growth. The review found that
“the UK’s patent system has played a well understood role in supporting innovation”
across the economy, including in pharmaceuticals, and plays an important role in incentivising investment in research and development. However, I acknowledge that some time has passed since that review was undertaken. There have been other specific issues raised by the noble Baroness and other noble Lords in this debate, and I would be happy to meet with interested parties to discuss those issues further.
I will now address the concerns raised by noble Lords about access to medicines and vaccines globally. The Government are committed to improving equitable access to essential medicines for people in low-income and middle-income countries. That is why the UK is the largest donor to Gavi, the vaccine alliance, having supported it since its inception in 2000. In the context of the Covid-19 pandemic, the Government recognise that the world urgently needs access to safe, effective, quality and affordable vaccines, diagnostics, medicines and other health technologies. As part of this, we remain committed to the arrangements in the TRIPS agreement, including the public health safeguards that it provides for signatory countries.
The existing IP framework supports research and development for new medicines and technologies, while voluntary licensing mechanisms and other flexibilities, as noted by the noble Baroness, ensure the transfer of and access to technology and know-how. Indeed, a strong IP framework was integral to the rapid development of safe, clinically effective vaccines.
The Government continue to think that the fastest way to deliver vaccines across the globe is to fund efforts such as the COVAX facility and the access to Covid-19 tools accelerator. To that end, we have committed up to £548 million to COVAX, which is one of the largest contributions made by any country. This will enable developing countries to access vital vaccines against Covid-19.
The noble Lord, Lord Alton, and the noble Baroness, Lady Wheeler, asked for an update on C-TAP. The Government continue to discuss C-TAP with stakeholders to identify where they can contribute to this initiative for global benefit. We recognise the need to understand how industry and research institutions can assist this initiative and we are currently working with the WHO to facilitate this.
Further, the existing flexibilities in the international IP framework and opportunities for voluntary arrangements are already being used to support the global response to Covid-19. For example, AstraZeneca has reached a licensing and technology transfer agreement with the Serum Institute of India to supply 1 billion doses of its vaccine to low-income and middle-income countries. Another initiative, DiaTropix, brings together British and Senegalese partners to share technology to produce 10 million Covid-19 antibody tests by March 2021, for use across west Africa.
I hope that this reassures noble Lords that the Government are prioritising access to medicines, vaccines and therapeutics in the UK and internationally, including for the poorest and most vulnerable. On that basis, I hope that the noble Baroness, Lady Sheehan, is able to withdraw her amendment.