Call for reform of international regulation of medicines and medical devices
The idea of international health cooperation and collaboration is gaining popularity in Europe, for example the proposal for an EU Health Union Professor Mihály Kökény, former Executive Board Member of WHO
International regulation on health technology is “disparate” and in urgent need of reform, a meeting of the All Party Parliamentary Group (APPG) on Medicines and Medical Devices has heard.
APPG chair Anne Marie Morris MP told the meeting there was no agreed system of regulation at any level. Resolving this issue was “mission critical” she said.
An APPG session on the future of international regulation of medicines and medical devices discussed what a global regulatory system might look like, particularly in the context of the COVID-19 pandemic and Brexit.
They also considered issues around the market access system as well as the role of the patient in regulation.
Ms Morris told the meeting that work on the international regulation of medicines and medical devices had been kickstarted by Brexit and the pandemic.
She said that Project Orbis (a US-based global collaborative programme to review and approve cancer treatments) was a great example of international regulation.
But there was a need for smaller countries, and developing nations, to be “part of the journey”.
Ms Morris highlighted some of the complex issues regulators were facing, including data-sharing and cultural barriers. She used the example of medical devices, noting that there were currently multiple directories that collected data in different ways.
She said that although there were some standard systems countries followed, they often achieved different results.
There are a number of different regulatory models, including the disease-specific approach, the geographical approach and the access model. Ms Morris said the access model was more flexible and was the one favoured by the World Health Organisation (WHO).
She said the challenge was enormous but the UK was at the “cusp of a new future” with many important choices ahead.
Professor Mihály Kökény, former Hungarian Minister of Health, and former Member of the Executive Board of WHO, said the idea of international health cooperation and collaboration was gaining popularity in Europe, pointing to the proposal for an EU Health Union as an example.
He added that the draft EU pharmaceutical strategy focuses on addressing some of the challenges of the interplay between medicines and medical devices.
He argued that the COVID-19 pandemic had shown that over-emphasis on a nation state’s sovereignty was a “dead-end” for health policies as viruses and other health risks did not respect borders. “We are entering a new age of health diplomacy,” he added.
Dr June Raine, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), said that the role of regulators was to enable access to medicines and medical devices, operate robust safety surveillance and take action when necessary.
She said it was important to ensure the patient was always be at the centre of the system.
She highlighted the advantages of international collaboration, such as a reduction in duplication and cost. However, she warned that it could inadvertently lead to increased bureaucracy, a slowdown in access and complex legal issues on data sharing and confidentiality.
There were multiple approaches to good international regulation, she said, such as work sharing. One example was the Access Consortium (made up of the medicine regulators from Australia, Canada, Singapore, Switzerland and the UK.
Or there was the therapeutic approach as exemplified by Project Orbis.
Dr Raine called for a greater focus on the public health driver of COVID- 19. She said that while millions people in the UK had now received a vaccine, there had not been a single jab in Africa outside of a clinical trial. This needed to be addressed, she said.
Richard Phillips, Director of Policy and Communications, Association of British HealthTech Industries, said that traditionally regulation was regarded as “something quite dry” but it was fundamental to relationships with the result of the world.
He said health technology was often considered as part of the broader life sciences sector, but he felt it was more part of the engineering sector.
On Brexit, Mr Phillip said that even in a system of harmonised technical standards, experiences of different regulators varied.
Dr Richard Pazdur, Director of FDA Oncology Center of Excellence, spoke about the development of Project Orbis,
He explained that pharmaceutical companies often went to the US first because of its “nimble” regulatory system, the size of its market and the favourable reimbursement system.
Project Orbis helps to speed up the pathway to get treatment applications to other agencies, he said, noting that it was an expensive programme but very important for global health.
When questioned on how countries such as India could benefit, Dr Pazdur explained that there was a template that drug companies use to supply information prior to their final application.
This allows the regulators to have a “jump-start” of up to several months. He added that it meant other regulatory agencies across the world could be part of the conversation and use the documents for their own review.
Dr Pazdur said there needed to be greater representation of ethnic and racial minorities, and the FDA was asking pharmaceutical companies to address this in regulatory trials or as a post-marketing commitment.
Dr R. Angelo de Claro, Associate Director for Global Clinical Sciences at FDA Oncology Center of Excellence, said under Project Orbis in 2020 there had been 49 approvals, up from 10 in 2019. The programme was very active and demonstrated the power of regulation.
Alok Mukhopadhyay, Chairman of the Voluntary Health Association of India and Convener of the Independent Commission on Development and Health in India, told the meeting he had recently met with India’s Finance Minister to convince the government that health was an investment, not an expense.
He spoke about the importance of global collaboration, arguing that “there was no alternative”. He said that governments needed to be much more proactive when it came to health crises.
Mr Mukhopadhyay warned that essential health research was not being prioritised or receiving investment in parts of the world. He added that most of the resources were going to inventions that gave more profit to the pharmaceutical industry.
Collaboration on regulatory mechanism was not enough, he argued. And he added that COVID-19 had led to “misplaced nationalism”.
Fiona Loud, Policy Director, Kidney Care UK, spoke about the role of the patient in the international system, saying that patients must be partners.
Although COVID-19 had affected some processes around shared decision-making, she said, it had also led to increased awareness of the MHRA. This could be an opportunity to involve patients more.
Ms Loud listed several important tests that regulatory systems should meet:
• Are patient voices included in processes for drug approvals?
• Are patients getting fast access to treatments?
• Are UK patients benefiting from UK research and innovation?
• Is there a mechanism to ensure parity between rare and common diseases?
She emphasised the importance of the patient voice, noting that experience of NICE was positive, but it was sometimes challenging for patients to get involved. Ms Loud warned that a bigger regulatory system could diminish patient voices.
She noted that charities often did not have the budget to get heavily involved in regulation issues, and she called for further mechanisms to be set up to encourage their participation.
Martin Hindle, Chairman of East Midlands Academic Health Science Network and a Non- Executive Director of Public Health England, said there were opportunities to deliver significant health improvements through innovation via the UK’s industrial strategy.
He said there was a need for strong infrastructure, an awards system, respect of intellectual property rights and a collaborative environment.
He went on to say that ‘blue sky’ thinking should be encouraged, alongside diverse cultures and systems and a favourable R&D tax system.
Mr Hindle spoke about the need to establish and agree targeted programmes. He highlighted one proposal around creating regional hubs of excellence.
These would include expertise across different sectors alongside the patient voice. Different groups would be involved, including regulatory agencies, an assessment and delivery group and a governance group.
• Professor Mihály Kökény, former Hungarian Minister of Health, and former Member of the Executive Board of WHO
• Dr June Raine, Chief Executive, MHRA
• Richard Devereux-Phillips, Director of Policy and Communications, Association of British HealthTech Industries
• Dr Richard Pazdur, Director of FDA Oncology Center of Excellence
• Dr R. Angelo de Claro, Associate Director for Global Clinical Sciences at FDA Oncology Center of Excellence
• Alok Mukhopadhyay, Chairman of the Voluntary Health Association of India and Convener of the Independent Commission on Development and Health in India
• Fiona Loud, Policy Director, Kidney Care UK
• Martin Hindle, Chairman of East Midlands Academic Health Science Network and a Non- Executive Director of Public Health England.
Ms Anne Marie Morris MP