Summary Of Health Secretary’s Appearance Before Brexit Inquiry
Health Committee – Jeremy Hunt, Lord O’Shaughnessy, MHRA – Brexit: the regulation of medicines, medical devices and substances of human origin
23/01/2018 DeHavilland Report – Parliamentary Committee
During a session of the Health Committee on the topic of ‘Brexit: the regulation of medicines, medical devices and substances of human origin’, MPs heard from:
- Lord O’Shaughnessy, Parliamentary Under Secretary of State at the Department of Health and Social Care
- Rt Hon Jeremy Hunt, Secretary of State for Health and Social Care
- Dr Ian Hudson, Chief Executive, Medicines and Healthcare products Regulatory Agency
Conservative Committee Chair Dr Sarah Wollaston opened by asking how disruptions in the supply chain would be avoided after Brexit.
In reply, Lord O’Shaughnessy said that the UK would seek a close relationship with the European Medical Agency (EMA) which replicated existing conditions as much as possible.
He continued that having “swift and frictionless” customs arrangements would also be crucial.
Then pressed on what contingency planning was taking place for if this could not be achieved, Lord O’Shaughnessy explained that, in the event of a ‘no deal’ scenario, the Government would have to ensure that there were still no burdens or barriers for businesses in the health sector.
Asked a follow up question on what the risks were in the event of no deal, Lord O’Shaughnessy replied that an independent consultancy had been commissioned to look in to this for availability of medicines.
The Chair then asked when the Department’s plans could be made available, prompting Lord O’Shaughnessy to say that he could not give a fixed date as this was only one part of broader negotiations and post-Brexit arrangements.
Labour MP Ben Bradshaw asked for “at least the broad brushstrokes” of the Government’s contingency plans for ensuring medical supply chains were not disrupted in the event of ‘no deal’ or a ‘hard’ Brexit.
In response, Lord O’Shaughnessy said that the EMA had issued some instructions on what the UK could do already and that the Department was in regular contact with industry.
Conservative MP Andrew Selous asked how the UK could ensure that British patients did not receive medicines slower post-Brexit.
Replying, Mr Hunt said that Brexit was acting as a catalyst for the Department to look at how the process of bringing medicines on to the UK market could be made quicker.
Then asked how Brexit could affect the accelerated access review, both Mr Hunt and Lord O’Shaughnessy expressed the belief that that process should not be impacted upon.
Replying to Mr Bradshaw’s question on the Government’s present position on membership of EURATOM, Lord O’Shaughnessy said that the UK would be leaving EURATOM when it left the EU.
He added that he did not believe that this did not prevent the trade of medical radioisotopes with the EU27, but did concede that swift customs checks would be required for this.
When asked by Mr Bradshaw whether ECJ jurisdiction would be required in order to participate in EURATOM and the EMA, Lord O’Shaughnessy expressed the belief that this was a matter for Brexit negotiations.
Mr Selous asked when confirmation of the conditions of the Brexit transition period would have to be made public in order to prevent the health industry from putting serious contingency plans in to place.
Responding, Mr Hunt described his encouragement that both sides had agreed to a transition period in principle and expressed hope that details could be tied up by the end of March.
When asked by Mr Selous for assurances that the needs of the health-related products sector were being taken in to consideration in Brexit negotiations, Mr Hunt said that key stakeholders were being listened to at the highest level.
Then asked a follow up question on how receptive the negotiating departments and teams had been to representations from the health sector, Lord O’Shaughnessy said that UK EU life sciences transition programme steering group had been set up after the EU referendum to enhance public-private engagement and that this group had been productive and listened to.
Asked by Mr Bradshaw what was holding up a transitional deal on health, Mr Hunt said that the details of such a deal were part of broader Brexit negotiations. He added that he was “very confident” that there would be a transition deal, and wanted to see it confirmed as soon as possible.
UK life sciences sector
SNP MP Dr Lisa Cameron asked what action would be required to protect the UK life sciences sector in the event of the Government being unable to negotiate its preferred deal with the EU.
In reply, Mr Hunt said that even in the event of no deal at all he did not envisage zero access to each European or UK markets. He also spoke of importance of the international quality of the UK’s science base, research institutes, and universities.
When asked by Dr Cameron about the potential for a ‘brain drain’ from the UK and a lack of clinical trials post-Brexit, Dr Hudson said that companies typically wished to run trails in countries with high research standards. He added that the same protocols could be used in the UK as at present in the EU as part of a multi-centre trial even in the event of a hard Brexit.
When pressed by the Chair, Dr Hudson said that it may be the case that the UK had to take separate applications to the rest of the EU for such trials.
Asked by Dr Cameron whether the UK was at risk of losing its leading role in the sector, Dr Hudson maintained that the country remained an attractive place to conduct medical research.
Labour MP Dr Paul Williams asked what advice was being given to medical companies in the UK regarding their preparations for life after Brexit.
Lord O’Shaughnessy replied by saying that the (Medicines & Healthcare Products Regulatory Agency) MHRA had issued guidelines. He added that he hoped that the industry would not have to adapt too much as a close relationship with the EU could be agreed.
Then asked by Dr Williams what the likely effect of no deal would be for UK companies in the sector, Lord O’Shaughnessy said that the industrial sector deal launched recently had led to further UK investment and that this showed how industry was not perturbed by Brexit.
Future UK-EU relationship
Asked by Dr Cameron which of the EU’s current trading relationship with third parties would be most beneficial for the UK life sciences sector, Mr Hunt said that he wished to see as close a relationship as possible maintained, albeit with different legal structures underpinning that relationship.
Responding to Mr Bradshaw’s point about the Government ruling out remaining in the Single Market and Customs Union, Mr Hunt said that being subject to ECJ rulings, which staying in the Single Market would entail, would be unacceptable after Brexit.
Dr Cameron suggested that the Secretary of State should be on the Cabinet Committee for European Union Exit and Trade, to which Mr Hunt replied that he joined the Committee’s meetings when issues directly related to health and social care were discussed.
Conservative MP Dr Caroline Johnson asked whether the Government would expect to accept new, incoming European clinical trial regulations when they come in.
In reply, Lord O’Shaughnessy said that it was preferable for the UK to continue to participate fully in the European regulatory framework in the health sector.
When asked by Dr Williams whether the Government was expecting to accept the medical devices regulations after Brexit, Lord O’Shaughnessy responded by saying that the decision would be affected by the length of the transition period and the nature of the future UK-EU relationship, in view of the fact that these regulations have already been agreed to by the UK.
In reply to a question from Mr Bradshaw on whether “permanent regulatory alignment” with the EU was an option, Mr Hunt said that regulatory alignment on an ongoing basis would be possible.
He continued by saying that it should be “completely acceptable” to have a mutually recognised legal underpinnings for medical standards, which had an agreed arbitration mechanism. However he cautioned against a system whereby the UK automatically adopted EU regulation.
Asked by the Chair why the EU would want to have an independent dispute arbitration mechanism rather than simply make the UK follow European rules, Mr Hunt asserted that this was the case in all trade deals which the EU had with third countries.
The Chair followed up by pointing out that regulation was not the same as trade.
Lord O’Shaughnessy expressed the belief that the contribution of the UK life sciences sector and organisations such as the MHRA put the Government in a strong negotiating position.
Asked by Dr Williams how pharmaceutical companies would ideally bring new medicines and products on to the UK market after Brexit, Lord O’Shaughnessy said that the hope would be for the UK to participate in the EMA so that there would be a continuation, albeit on a different legal basis.
Then asked a follow up question on how this arrangement would be affected by a future change in UK policy, Lord O’Shaughnessy conceded that diverging legally or in terms of standards could jeopardise this process.
Asked by Dr Johnson whether non-alignment on data regulation beyond March 2019 was being considered by the Department, Lord O’Shaughnessy replied that the Government was currently focused on implementing GDPR to be aligned with the best European standards.
Replying to a question from Dr Williams on how the Government had worked with the EMA on their relocation, Mr Hunt explained that he had spoken to the Dutch health minister and that they had agreed that a smooth transition was in everybodys interest.
Dr Hudson echoed this view.
Then asked by Dr Williams whether the witnesses agreed with the guidance given by the EMA to their workers that the Agency would have been fully moved out of London by March 2019, Dr Hudson said that this was his understanding.
Dr Wollaston expressed concern about the availability of qualified persons post-Brexit, prompting Dr Hudson to say that all eventualities had to be planned for but that continued collaboration on labour and qualification was the desired option.
Then asked a follow up question on whether training UK qualified persons was occurring already, Dr Hudson said that planning was taking place for the event of ‘no deal’ but there had not been programmes put in to place.
Conservative MP Johnny Mercer asked what the Department of Health and Social Care (DHSC) was doing to prepare for the future.
In response, Mr Hunt said that there was greater emphasis on training new nurses, doctors, and care workers in the UK.
Mr Mercer then asked what assurances could be given to health workers and their families, prompting Mr Hunt to say that good work had already been done on EU citizens’ rights in the first phase of Brexit negotiations.
He added that the number of European nationals working in the NHS had risen since the Brexit referendum.
Lord O’Shaughnessy continued by saying that the mutual recognition of qualifications had also been a key agreement reached with the EU in this respect.
Mr Bradshaw questioned the figure for the number of EU nationals working in the NHS and asked the witnesses to check it.
He also asked whether the Government’s objective of reducing net immigration to “tens of thousands” was compatible with maintaining the health service after Brexit. In reply, Mr Hunt said that immigration was a key concern for voters, but asserted that the Home Office were receptive to representations from DHSC.
The UK’s international role
Replying to a question from Mr Selous about the UK’s global role going forward, Mr Hunt said that it was important to preserve the UK’s status as one of the three major international centres of innovation in the health sciences sector.
In reply to a question from Dr Johnson on participation in Framework Progress 9, Mr Hunt explained that the UK may wish to continue to be a part of EU research programmes after Brexit.
He added that the British Government would be able to provide additional funding for research from the domestic budget to compensate for any loss of European funding.
Then asked by Dr Johnson whether researchers participating in cross-border EU programmes would be able to stay in the UK beyond March 2019, Mr Hunt gave assurances that there would not be a “brain drain” and that the Government would continue to support research centres in recruiting from abroad.
Responding to Mr Bradshaw’s question about the cost of participating in EU programmes, Mr Hunt said that this was subject to ongoing Brexit negotiations but that it would be possible.
Then pressed on whether those costs were already part of the withdrawal settlement, Mr Hunt conceded that they would be additional fees.
Mutual recognition of qualifications
When asked by Dr Cameron which aspects of the mutual recognition of professional qualifications would be continued after Brexit and which would not, Mr Hunt said that the ongoing recognition of qualifications for those already in the UK had been confirmed but that the status of new arrivals was yet to be negotiated.
He added that the Government’s priority was that the UK be able to attract quality medical practitioners.
Responding to a follow up question about the tension between assessing practitioners from Europe whilst being able to fill jobs in the NHS, Mr Hunt explained that the General Medical Council (GMC) already had a good system for assessing those from outside of the EU and that this could be replicated.
Asked whether free healthcare would still be available to UK nationals on holiday in the EU post-Brexit by Dr Williams, Lord O’Shaughnessy said that reciprocal healthcare would continue until March 2019 and that the Government wished to see this state of affairs maintained in the long term.
When asked about the significance of adding “Social Care” to his department’s name, Mr Hunt said that it was symbolic to have a Secretary of State with social care in their title and job description for the first time.
Then asked whether this signified a change in funding, Mr Hunt conceded that it did not. He did, however, say that he would be responsible for the social care green paper.
Replying to a question from Mr Selous on what the Department was planning to do to address issues in social care, Mr Hunt raised the issue of people not saving to pay for social care costs in the same way which they pay in to a pension. He also pointed to funding pressures at the national level.
Asked by Dr Williams about the possibility of combining the social care green paper and the proposed ten year plan for the NHS, Mr Hunt replied by saying that he would welcome bringing the two areas closer together generally in light of how interconnected they were.
In response to a follow up question on whether social care costs should be borne by the individual or pooled in a model similar to the NHS, Mr Hunt said that there was currently a mixed approach. He continued by saying that the risk pooling aspect of the system did not work effectively at present and had to be reviewed.
The Chair asked whether the Secretary was making the case for having a broader review of social care and health funding, Mr Hunt expressed the belief that the health and social care systems were “umbilically” linked and that consequently the two had to be viewed together.
Dr Johnson asked how the DHSC would work with the DCLG considering the latter was in charge of funding the local governments who delivered social care. Replying, Mr Hunt said that DCLG would remain responsible for local government and thus social care funding, but that the two Departments worked closely together.
Mr Selous asked for the Secretary’s comments on the social care system in Germany, which he described himself as a great success. In response, Mr Hunt said that the German system was “interesting”, as were the situations in Japan, Spain, and Italy. He added that he was open to learning from different countries but did not believe that any
Future of the NHS
Asked about the streamlining of NHS procurement by Dr Cameron, Mr Hunt said that it was important to allow smaller companies to bid for public sector contracts moving forward, but that ensuring good value for money to the taxpayer was of paramount importance.
Mr Mercer asked what the options on the table were for improving social care, to which Mr Hunt replied maintaining the “founding values” of the NHS, seeing funding and workforce as intrinsically linked, and ensuring that care was not just available but of high quality were all key.
He added that there was a lot of consensus in the NHS about the importance of integrated care, equality, and access.
In reply to Mr Mercers assertion that the need for more funding was the “elephant in the room”, Mr Hunt said that the Government would have to “take some important decisions about long-term funding”.
Asked by the Chair whether he was concerned that money for NHS England had been taken out of the budgets for Public Health England and Public Health Prevention Workforce and whether he might reverse the decision, Mr Hunt said that all parts of the health system had had to make savings. He added that outcomes were more important than funding in public health, and that these were still positive.
Mr Hunt said, when asked by Dr Wollaston, that he believed both Number 10 and the Treasury understood the importance of increasing health spending in order to keep pace with growing demand.
The Chair noted concern that Accountable Care Organisations (ACOs) were mechanisms for privatising the NHS and asked whether their introduction could be paused while consultation took place.
Responding, Mr Hunt gave reassurance that ACO contracts were not designed to increase private sector involvement in the NHS. He also asserted that there was a difference between outsourcing and privatisation.
Replying to a follow up question about the risk of a private sector company taking over an ACO, once formed, Mr Hunt said that it was not the intention of new regulations in this area to make it easier or more difficult for companies to take on contracts.
He continued by saying that legally it was uncertain whether the Government could prevent any particular form of organisation bidding for contracts.
The Chair pressed for a delay in the implementation of ACO legislation to give greater time for scrutiny, to which Mr Hunt said he would look at the Parliamentary timetable but did not want to hold up the work being done.
He suggested that comments on these changes could form part of a broader public NHS England consultation.
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