127.Judging by the comments of the Secretary of State for Health in oral evidence, it appears that the UK will require a new regulatory procedure for health-related products, and substances of human origin. Mr Hunt said that the UK will leave the European licensing system for medicines:
I do not expect us to remain within the European Medicines Agency, but I am very hopeful that we will continue to work very closely with the EMA.
128.The Government’s position on this issue, however, appears somewhat uncertain. Following the Secretary of State for Health’s remarks other Government Ministers have suggested that this approach is not set in stone. David Davis MP, Secretary of State for Exiting the EU, told the House of Commons that Mr Hunt did not say that the UK will leave the EMA and that he has been misquoted and misinterpreted. We, however, did not perceive any equivocation in the Secretary of State for Health’s remarks, which left little room for misinterpretation.
129.In addition, the question of adjudicating disputes is fundamental to the UK’s future relationship with the EMA. The Secretary of State for Health has told us that Britain would not be subject to ECJ rulings and explained this this is a “matter of sovereignty”.
130.We are concerned by any policy changes that could deny patients in the UK swift access to the newest drugs and treatments. The King’s Fund’s written evidence highlighted the potential complications that will arise should the UK remove itself from the auspices of the EMA:
The UK has its own national regulatory agency, the Medicines and Healthcare products Regulatory Agency (MHRA). However, this deals with national authorisations intended for marketing only in the UK. The inclusion of EEA and EFTA countries for centralised marketing authorisation may mean that, despite leaving the EU, the UK could continue its relationship with the EMA. If this is not the case, however, pharmaceutical companies may need to apply to the MHRA for authorisation for any medicines they wish to supply to the UK. Concerns raised in a recent report from the UK life sciences sector included that no longer being in the EU regulatory system could result in the UK becoming ‘a second priority’ launch market, that ‘there is no appetite to add regulatory bureaucracy by losing European scale and consistency’, and recommending that alignment with the EU regulatory system be maintained (UK EU Life Sciences Transition Programme Steering Group 2016).
131.NHS Providers’ evidence echoed the views expressed by the King’s Fund and said that there is a risk that Brexit may limit access to new medicines for British patients as they will not be introduced in the UK as quickly as is currently the case. The Academy of Medical Royal Colleges said in its evidence that the UK is “heavily reliant” on the European Medicines Agency (EMA).” Its submission described the wider consequences if the UK were no longer to be part of the EU approval system:
If not part of the EMA we would be unable to participate in the European wide approval system for new medicines and the revisions to already approved products, to participate in the Orphan Drug Designation and the Small to Medium Sized Enterprise schemes that the EMA operate or to participate in the specific centralised approval process for paediatric drugs and the process that supports new medicines development for children. We would also lose access to the EU wide Pharmacovigilance networks and the EU Clinical Trials Database.
132.At this stage of negotiation it is premature for the UK to rule out continued membership of the EMA. Prior to the announcement of the general election our intention had been to investigate how the Government will meet its objective to “ensure that patient access to medicines will not be adversely impacted” by Brexit. We note, however, that whatever the relationship we finally agree with the EMA, medical devices and substances of human origin are regulated by separate EU laws, which will also need to be replaced post Brexit.
133.In the next stage of our inquiry we had planned to explore the choices that will have to be made to ensure safe access to drugs, products, devices and substances of human origin. We had also intended to investigate any opportunities that may arise to plug regulatory gaps and adapt regulation to new technologies and personalised medicine. Given the subject matter, this topic needs Parliamentary oversight and we hope that our successor committee will prioritise this work in the new Parliament.
134.In its written evidence the Royal College of Physicians (RCP) outlined the public health issues that it believes will be a priority for the Government during Brexit negotiations. The RCP noted a range of areas where EU standards are central to health protection:
the EU has developed wide-ranging frameworks for controlling environmental pollutants, including water and air quality, as well as risks from chemical products, health and safety in the workplace and the safety of consumer products. No less important are the frameworks for control and marketing of pharmaceuticals (based on the European Medicines Agency, currently based in London), and medical devices. In all these areas EU systems and standards underpin health protection in the UK, and it is crucial that either the UK maintains its involvement in them, or that they are replaced by equivalent or stronger national ones.
135.NHS Providers’ evidence said that the
benefits of maintaining the UK’s participation in the European Centre for Disease Control should be a central consideration in respect of the health implications of Brexit.
This point was noted by the Department of Health in its written evidence which said that “The competence for responding to cross-border threats lies with Member States” but “coordinating through these systems enables us to be aware of emerging problems and thus respond rapidly to threats, for example Ebola.”
136.The position taken by NHS Providers was echoed by both the Academy of Medical Royal Colleges and the RCP. The RCP said in its evidence that this should be a priority in negotiation and warned of the risk of ending participation in the EU wide systems:
There is a need to provide effective surveillance of health threats, including communicable disease outbreaks and natural disasters. The EU has established several important alert, coordination and response mechanisms, many of which are operated via the European Centre for Disease Prevention and Control. The UK in isolation cannot effectively tackle what are inherently transnational threats and therefore needs to have continued access to these European structures and networks.
137.Maintaining pan-European cooperation on public health issues was viewed by the Secretary of State as an existing mechanism that would not be jeopardised by Brexit. The Secretary of State outlined the rationale for his optimism but did not describe how the system would operate with the UK outside the EU:
Obviously, we want to continue all aspects of co-operation with our partners and friends in the EU post-Brexit in order to reduce public health risks. It is incredibly unlikely that they will not want to do that, because it is as much in their interests as it is in ours.
138.A range of opportunities arising from Brexit to enhance public health regulation were highlighted by witnesses to this inquiry. The Faculty for Public Health said in its written evidence that
Aspects of labelling, marketing, taxes and pricing are maintained at EU level. EU directives dictate that stronger ciders and wines be taxed based on volume and not alcohol content. Government will have the opportunity to raise taxes on products e.g. high strength ciders and wine, often the drink of choice for heavy drinkers. Government should ensure its ability to tax wine and cider is proportionate to strength.
139.It was also observed by the Association of Directors of Public Health (ADPH) in its evidence that UK tobacco regulation has exceeded EU minimum requirements. It too called for further action to tackle alcohol misuse and advocate using Brexit as an opportunity to introduce Minimum Unit Pricing.
140.Similarly, the Faculty for Public Health believes that Brexit presents an opportunity to enhance front of pack of traffic light labelling for food:
The EU Nutrition and Health Claims Regulations provide consumers [with a] high degree of protection against misleading nutrient and health claims. This should be directly transposed into domestic legislation and not weakened. The Food Information Regulations dictate what information can and cannot appear on food packaging.
Brexit is an opportunity to strengthen these regulations by mandating the national front-of-pack colour-coded labelling scheme to ensure inclusion on all food products on sale; revising the traffic light bands (thresholds) for sugars downwards to be in line with new 2015 SACN population targets for sugar consumption.
141.The British Dental Association highlighted the potential to go further on these issues than has previously been possible because of resistance from other EU member states:
There is a positive opportunity in that traffic light labelling–a voluntary UK scheme challenged by some other EU countries–could be expanded in the future.
There are opportunities relating to alcohol duty, with potential for full reform of the duty structure in the long term. The exemption of alcohol from nutrition labelling requirements can also be reassessed in future.
142.Our intention—prior to the announcement of the general election—had been for our Brexit inquiry to examine how cooperation will be maintained across a broad range of areas. Questions remain over the UK’s continued participation in health-related EU research programmes such as those investigating rare diseases that rely on large sample populations. The financial support for cross border work such as that provided by the European Investment Bank, Horizon 2020 funding, EU public health programmes, the European Social Fund and the Regional Development Fund is also in question. We believe that these are all areas that will require scrutiny by our successor committee.
143.Market functioning and trade agreements can also have a fundamental impact on the delivery of health services. Both the Nuffield Trust and NHS Providers highlighted concerns about the operation of the EU public procurement directives which can require open competitive tendering within the NHS. Similarly, there is a potential to explore the implications of future bilateral trade agreements with countries such as the US which could have implications across health and social care.
137 Q 67
138 HC Deb, 26 January 2017, [Commons Chamber]
139 Q 82
140 para 3.7
141 NHS Providers () para 5.4
142 Academy of Medical Royal Colleges () para 14
143 Ibid para 15
144 HC Deb, 28 February 2017, , [Commons Written Answer]
145 Royal College of Physicians () para 15
146 para 5.6
147 para 27
148 para 17
149 para 17
150 Q 97
151 Q 97
152 Faculty of Public Health, Royal Society for Public Health, Association of Directors of Public Health and the UK Health Forum paras 9 -10
153 The Association of Directors of Public Health () para 2
154 paras 12 - 13
155 British Dental Association () paras 27 - 28
156 para 8
157 para 3.1, paras 2.7–2.8
158 Q6, Q104
27 April 2017