Introduction
The UK Government has determined that on 23rd June 2016 the British people have to take a really momentous decision: whether the UK should remain as a member of the EU, or leave it. That decision will have major implications for the future health of the British Public.
The EU affects our health and health services in many and complex ways; usually to our benefit (1). However, surprisingly few people appreciate that over half of the determinants of the health of all EU citizens are subject to legislation and policy development at EU level. This is largely because nearly all legislation on environmental protection, food and employment law is made at EU level, plus many aspects of treatment services.
We currently participate actively in these legislative processes, via our elected MEPs, via the Council of Ministers and via EU Directorates (2). However, should the UK decide to leave the UK, Britain would probably remain subject to much of this legislation, but without then having any input into its design or amendment.
These issues are considered in more detail in the paragraphs below.
- What sort of Brexit?
- So far there has been no clarity among those arguing for Brexit as to what form it would take, with some, such as Boris Johnston, seeing a “leave” vote as a means to negotiate a different deal that would then be put to a second referendum, while some seem to favour a relationship solely confined to that operating within World Trade Organisation rules, and others have argued for almost everything in between.
- A decision to leave would trigger Article 50 of the Treaties (3), so that the UK would then be excluded from negotiations on a new relationship with which it would be presented. This would be subject to unanimity among the remaining 27 member states, any of which could veto it if they felt it was unduly generous.
- Some supporters of Brexit have argued that certain rights, such as those of UK pensioners to live in Spain, would be protected; however, this is categorically untrue (4). Article 70 (3) offered no acquired rights where a treaty, such as the Lisbon Treaty, has an exit clause.
- If after Brexit, there should be agreement to opt back into many EU services, including single market, the UK would then have to pay for these by continuing to contribute to the EU budget, and would have to apply most EU legislation to UK, without having any say in the nature or details of this legislation (the same situation as Norway has (5)).
- A further degree of separation, as Switzerland has (6), would only allow more limited access to the internal market, including some restrictions on labour mobility (e.g. for health service workers). That agreement also excludes Switzerland from the single market in services, which would have profound implications for the UK economy (explaining why major financial organisations have indicated that they would move to Paris or Frankfurt). Crucially there would also be restrictions on UK institutions’ participation in EU research projects and eligibility to receive EU funds (Swiss institutions are not eligible to lead research projects). Brexit would also imply a major loss of influence for of some important UK institutions such as the Wellcome Trust or Cancer Research UK, both of which often lead EU research projects. UK NGOs/charities (e.g. those concerned with health matters, social issues, environment or other socio-economic determinants of health, etc. ) which currently benefit from EU funding, would lose £200m in funds annually.
- Even more distant relationships are also possible, such as that between the EU and Vietnam (7) or Peru, although that may not be acceptable to supporters of Brexit as these include commitments to social protection that they have already rejected.
- However, given the almost infinite permutations, for pragmatic purposes a complete separation seems to be more likely in the case of an “out” vote, so the remainder of this briefing will be based on this assumption.
- Peace in Europe:
- War and threats to peace present some of the most serious threats to good public health. After over 300 years of bloody wars in Europe, the first original objective of the EU was the promotion of peace in Europe. Apart from a few exceptions, peace has been maintained in Europe since 1945.
- If the referendum in UK leads to a “Brexit”, this could encourage right wing nationalist elements in various EU member states to lobby for similar referenda in their countries, and there could be a risk of erosion of the EU by the separation from of extremist right wing-led nationalist states. War might not be so far away, as in ex-Yugoslavia in the 1990s (one of the exceptions referred to above). Several leading political commentators and historians have posited that if the UK votes to leave the EU, then referenda would be likely to follow in Denmark and Sweden, and possibly in Ireland, Czech Republic, Poland and Hungary. Another manifestation of European disintegration might be that, in the case of the UK as a whole voting for Brexit, Scotland would vote to leave the UK in order to stay in the EU (8).
- EU membership demands that member states respect certain values and principles as a condition of membership (Article 2 of the Treaty of the European Union (9). This includes democracy and the rule of law, as well as non-discrimination and respect for human rights. It provides an overarching supranational accountability for the UK government in respect to these values, all of which are essential to health and well-being.
- The current migrant crisis is arguably one of the largest challenges to Europe and its member states in modern times. Not only does this bring humanitarian and public health challenges, but also it demonstrates the modern necessity of cooperative public policy across member states for adequate and appropriate action to address modern complex challenges.
- Public health:
- PH powers are small but significant (10, 11); exclusion from the European Centre for Disease Control (ECDC), and exclusion from EU communicable disease control systems would follow a complete Brexit. A crucially important role for the EU, which could not be effectively fulfilled by national governments independently – the alert and communications systems, such as the Early Warning and Response System and the systems managed by the ECDC – have improved considerably the degree of information sharing and coordination of response at EU level to cross-border health threats (12) (used during Ebola and swine flu outbreaks). Exclusion from the EU Public Health Programme (13), which enables much joint learning across EU borders, and from which many UK health agencies currently benefit, would also follow a complete exit from the EU.
- Another exclusion would be from the benefits of the European Food Safety Authority (EFSA) (14), which monitors and provides early warning of threats to food safety across Europe. Exclusion from consumer product safety legislation (15) (including for both cars and toys) would follow a Brexit.
- Exclusion from the EU`s powerful voice on health matters in international affairs (e.g. with WHO (16), where the 28 Member States adopt an agreed position, from which the UK would be excluded) would also follow.
- There would also be exclusion from legislation ensuring the safety of medicinal products and medical devices. At present, standardised and effective medical technology approvals are easily available:
- Pan-EU medical devices regulation (17) offers speedy and cheap access to EU markets for medical technology firms. Small and medium-sized enterprises (SMEs) make up 97% of the sizeable UK med/tech industry. The cost of gaining approval for their product sales in the UK and EU separately would place an unrealistic cost burden on them – preventing them from selling competitively into the EU market.
- Turnover in the medical technology sector in the UK has grown year on year since 2009 – this trend would be unlikely to continue if UK companies were not able to access both the UK and EU markets through a single approval process.
- Currently, the EU medical devices approval process is recognised as being supportive of innovation – especially when compared to Food and Drugs Administration approval in the USA, which, on average, takes five years longer to approve new medical devices.
- Coordinated improvements to public health and health security:
- Common standards across the EU facilitate the movement of tissues, cells and organs across member states, ensure traceability and standardise safety reporting systems to pool info from across the EU. Cell based treatments not available in the UK can be imported for named patients and UK citizens can receive suitable organs from across Europe (18).
- Common standards make it easier to import foods from other EU member states to the UK (19), ensuring the quality of a wide choice of products. EU-wide rules against illicit trade of tobacco products, including an EU-wide tracking and tracing system for the legal supply chain and visible and invisible security features (e.g. holograms) which should facilitate law enforcement. This also applies in the case of combatting counterfeit medicines.
- There are also other systems of cooperation which could not be achieved by a single Government alone; examples includes incentivising the development of new antibiotics and vaccines (for example, through the Innovative Medicines Initiative (20)), better data and early warning systems across the EU, and conserving existing antibiotics. This can also apply in the case of new treatments for rare diseases and for joint or pooled EU-wide procurement policies for orphan drugs.
- anti microbial resistance represents a large and growing threat to the UK public. This major health threat can only be effectively dealt with at an international level, by all euro health agencies.
- The environment and climate change:
- Environmental legislation is almost entirely an EU competence (21).
- The environment cannot be controlled at the nation state level (air, water, other pollutants, and the climate itself are no respecters of European borders).
- Significant improvements in air quality and quality of bathing water in the UK, to take two examples, have been due to environmental legislation at the EU level. It is also worthy of note that the UK Government opposed most of these legislative matters when they were adopted. Without EU membership, Britain would be suffering from poorer air quality (22) and dirtier water (23). It is not unreasonable to assume that the UK Government would aim for weaker standards (or even scrapping some standards entirely) if competence were to return to national level, not only for air and water pollution, but also with respect to chemicals and pesticide use, waste management, recycling and energy-saving legislation, labelling of household appliances, laws monitoring and limiting pollution and energy used by industrial installations, and those applying to power stations, emissions standards, and fuel-efficiency in transport.
- The EU has taken a world lead in addressing climate change (24) – could the UK do this? Would it try? Or would Brexit lead to backsliding on climate policy in the UK?
- The European Chemicals Agency (25) is the body overseeing implementation of the REACH legislation, which is a register and authorising body for chemicals in Europe This has banned or introduced very strict controls on the most toxic substances (it is noteworthy that the US chemicals authorisation regime is far more lax than this, e.g. it still has not entirely banned asbestos). If the UK were to leave the EU, it is unclear whether UK would still be party to ECHA information – or whether the UK would also aim to step completely out of the REACH legislation (which businesses, including UK chemicals and agro-chemical companies, criticise as costly).
- European environmental policy requires links with agricultural policy (26), which would be unlikely to be achieved other than at EU level.
- Agriculture food and nutrition:
- What we eat is first and foremost dependent on what farmers are encouraged to produce through subsidy, all determined at EU level (27, 28); what would UK farmers produce after Brexit, and how would they be supported? As according to current EU Common Agricultural Policy (CAP) plans, €27.8 billion are to be invested in UK farming by 2020. Would the UK Government match this investment?
- Current agricultural policies in Europe, North America, and in other developed countries pose threats both to nutritional health and to climate change (26); UK can only be in a position to influence appropriate policy reform from within the EU.
- If farmers are to qualify for CAP subsidies, they have to comply with EU standards for environmental protection, animal welfare, and food safety (29, 30). Would UK maintain all of these high standards outwith the EU?
- European agriculture is responsible for release of more global warming gases than is any other industry (26), and the EU is beginning to address this.
- Legal constituents of food (and the banning of illegal constituents) are all defined as according to EU legislation (31).
- Food labelling regulations are all set at EU level (32); a recent Directive extended food labelling regulation considerably, but further reform (including provision of simpler guidance to consumers) is needed, and the UK is well-placed to take a lead here to promote appropriate policies (with its exemplary, albeit voluntary, traffic lights scheme).
- EU regulation currently bans use of hormones (33) and antibiotics (34) as growth promoters in livestock production (this is not the case in the USA). As already noted, EU regulation is also considerably stricter than is that in the USA on toxic pesticides; would the UK outwith the EU maintain these standards?
- The UK is unable to produce on its own anything approaching a sufficient supply of fruit and vegetables in order to fulfil every citizen’s daily recommended intake amount of 400gm. (29, 35) The UK imports two and a half times more food from the EU than from the rest of the world, and new tariffs – which would need to be re-negotiated – would add costs to imports. Moreover, in terms of global (free) trade agreements, the UK benefits currently from block EU-wide negotiating power.
- Social dimensions:
- Health and safety at work legislation is basically European (36); after Brexit would the UK maintain the same high standards? The UK Government has generally opposed EU legislation in this area.
- The Social Chapter (37) provides benefits that would otherwise be unheard of in UK, including generous maternity and paternity leave after birth of a child, or after adoption; guaranteed holidays (a minimum of four weeks paid leave) and right not to work more than 40 hours per week without financial compensation; equal pay and protection from sexual discrimination in the work place; equal rights for part-time workers to paid leave, pensions, and access to training; and protection against unfair dismissal. All of these are essential to addressing social and economic determinants of health, as well as contributing to the reduction of health inequalities.
- The Working Time Directive (38), though often derided in UK, gives employees guarantees about maximum working time, encouraging more satisfactory work / life balance.
- The UK risks exclusion from the EU-wide framework for EU action on protection of children’s rights, including child protection in cross-border movements, safeguards for children who are victims of crime, victims of sexual abuse and exploitation, and victims of trafficking: this is the European Child Rescue Alert (AMBER) (39).
- UK is one of the leading EU member states on advancement of lesbian, gay, bisexual, trans or queer (LGBTQ) rights (40), setting an example for other EU countries to follow.
- Regional Policy:
- After the Common Agricultural Policy, Regional Policy comprises the next largest item in the EU budget; this is mainly used to promote social, economic, and infrastructure development in less developed areas in the EU; many areas within the UK (41) have benefited from Regional Policy support (usually from either the European Regional Development Fund or from the Social Fund), and some UK areas are still benefiting. In particular, Cornwall and some areas of Scotland, Wales, Northern England, and Northern Ireland are still net recipients from the Structural Funds budget. In a post-Brexit UK, would similar transfers of capital be provided from south east England to other areas?
- Since 2007, health development has become recognised formally as a component of social and economic development, and the Regional Policy budget has included a sum of €5,000,000,000 “top-sliced” to support health development (42). This has led to some impressive developments (e.g. in Italy and Spain), Recently, Northern Ireland has drawn on these funds to support building of a new hospital and primary care infrastructure, and similarly other UK health infrastructure projects are in development.
- The Single Market:
- EU procurement rules (43) provide equal access to markets across the EU; Brexit would exclude UK health-related industries (e.g. pharmaceuticals) from access to public contracts on the same basis as that available to firms within the remaining EU.
- Access to the Single Market: the EU Single Market (44) means UK pharmaceutical companies have access to 27 other national markets (besides Norway and Switzerland, etc., in addition) and to over 500 million potential customers. As one of the largest UK industries, this reflects £billions for UK life sciences companies.
- All 10 major pharmaceutical companies have bases in the UK (45, 46), and from these bases they sell into the EU market. If the UK were no longer to be part of the single market, these companies could well move their bases elsewhere within the EU, in particular following relocation of the EMA.
10. Free movements of health professionals around the EU, with mutual recognition of professional qualifications (47), would not include UK after Brexit, creating problems for the staffing of hospitals, etc.
- At present, there is easy access to skilled labour, and this free movement of health professionals benefits health professionals individually, and the UK generally as a net importer of health and social care professionals. This ensures that skills gaps in the UK workforce are filled quickly, and is particularly important in the NHS and for medical specialties, as well as e.g. home and institutional care for the elderly, as part of UK current efforts to increase domestic medical workforce supply (48).
- The UK life sciences sector also benefits from free movement of skilled people within the EU. The UK currently acts as a hub for global researchers (49), attracting more university-educated EU citizens than any other member state, and resulting in 20% of the UK academic community being made up of EU nationals. Brexit would see the UK excluded from the Erasmus and Marie Curie schemes that provide for mobility of early career researchers, as well as the EPIET programme (50), providing training in communicable disease control. The quality of UK science is strengthened and acts as a vital magnet for life sciences investment.
11. Standardised medicines approvals:
- Registration and approval of pharmaceutical products is carried out for the entire EU by the European Medicines Agency (EMA) – actually based in London – providing a benefit in terms of efficiency and predictability (51); Brexit would exclude new UK pharmaceuticals from approval for use across the EU;
- The Association of British Pharmaceutical Industry (ABPI) (52) said “Prior to the implementation of the centralised procedure, companies either licensed their medicines using national authorisation procedures or by processes coordinated by the Member States. These processes were unnecessarily burdensome as they required individual applications in each Member State, leading to individual authorisations in each country and information provided to patients which could be different in each Member State. The introduction of the centralised procedure, along with the creation of the EMA, not only greatly simplified the above situation but also resulted in a system where medicines information such as the patient information leaflets are consistent across all EU Member States, which is good for public health protection.”
- EU membership not only improves the way we trade within the single market but also outside of the EU. The EU carries out bilateral trade agreements with external markets. For example, the current EU-US trade negotiations (53) are seeking to reduce duplication between EU and US regulatory systems for medicines, reducing costs for companies and enabling more efficient use of resources by regulators. It would be harder, if not impossible, for the UK on its own to achieve this.
12. International influence on medicines and device regulation:
- Leaving the EU would mean losing our ‘seat at the table’. Non –EU countries, such as Norway, can choose to sign up to EU regulations in order to lessen the regulatory burden on companies based in such countries wishing to trade with the EU. However, whilst these countries can sign up to regulations they have no voice in the development of these regulations. For example, a revision of the regulations around medical devices is currently under way, and the UK is heavily involved in these negotiations. The UK Government is able to ensure that the interests of both UK government and UK industry are reflected, whereas Norwegian (5), Icelandic, Swiss (6) and Turkish counterparts, who will be effected by the resulting outcome, have no opportunity to comment or to participate in the legislative process. As already stated, the EMA`s headquarters are in the UK and the UK is an active member. If the UK were no longer members of the EU this situation would, of necessity, change (54). As such, the UK`s influence in the approach to medicines in the EU would be greatly diminished. Moreover, the Swedish, Danish and Italian governments are already formally registering their interests in hosting the EMA, should the UK vote to leave. It is as yet uncertain if the UK outside the EU would still be party to EMA decisions and approvals or if it would have to duplicate these at a national level.
- UK Research excellence, and access to research funding:
- UK health researchers could be cut off from working as a part of the most significant public health research community in the world.
- UK health researchers will be cut off from a major source of research funding (55).
- Based on the proportional contribution to overall EU finances, the UK contributes around 11% of the EU research budget and receives around 16% of the allocated funding, making it a significant net beneficiary (56).
- The UK is the largest EU Member State beneficiary of EU funding for health research (57, 58). Data released in October 2012 shows that, in the health theme of the FP7 Cooperation Pillar, the UK had attracted over €570 million in EU funding, 17 per cent of the whole EU contribution and €30 million more than Germany, the second highest beneficiary.
- EU funding benefits the whole of the UK – not just South East England (57, 58). Of the EU funding framework which ran from 2007-2013, 107 EU research infrastructure projects were supported in the UK, of which 69 (64%) were outside the ‘golden triangle’ of Oxford, Cambridge and London universities.
- Cross Border Healthcare for UK citizens
- The Cross Border Healthcare Directive (59) enables residents of any EU member state to be able to obtain investigation and treatment anywhere in the EU, paid for by the purchasers in the patients` own home member states; these EU rules mean that British patients have clear rights to purchase healthcare in other Member States and then claim reimbursement from their UK healthcare purchasers under certain conditions. Brexit would exclude UK citizens for this, so there could be no more free spectacles or dental treatment in Budapest, nor joint replacements in France.
- This Directive also sets out a commitment to create a system of European reference networks (60), which would create teams across EU member states which could share healthcare advice on (for example) rare diseases. This should lead to a wider pool of patients with rare diseases, which would allow Britain to continue to progress its world-leading research on rare diseases, which is currently hampered by lack of patients to help with research. There will be a call issued to establish the networks in May 2016, and the first networks will be set up in 2017.
- In addition to the ability to use health services across the EU, there are longer-standing arrangements for access to emergency medical care. British patients have the right to access medically necessary healthcare services when abroad in other EU countries temporarily. Many UK citizens go on holiday within the EEA with the peace of mind that should they fall ill, their health needs will be taken care of via the European Health Insurance Card (EHIC) (61).
- There are around 1 million UK citizens who are permanent residents in Spain, and over 300,000 live in France; most of these are pensioners who can benefit from free access to local health services as well as access to their (UK state) pensions (62). Both health service access and transferability of pension payments may have to be renegotiated in the case of Brexit. Maybe new rules would be have to be renegotiated bilaterally with each of the remaining 27 Member States on the permanent residency status of British citizens (pensioners, students, workers, etc.) living in the residual EU.
- In 2012/13 the UK paid a net £805 million to other EEA countries to cover the healthcare costs of those for whom it is responsible, the majority of whom were for UK state pensioners living in other EEA countries (63). This is widely believed to underestimate the true cost to the countries in which they live. Many more UK pensioners choose to live in other EEA countries than pensioners from those EEA countries who live here. As already noted above, there is no guarantee that they would be able to remain in those countries post Brexit.
- Some further challenges posed by the internal market:
- Due to a central principle of the European Union being its competence for internal market legislation, there is as a result a paradoxical challenge to public health.
- The uninterrupted functioning of the internal market in goods and services is the basis of most EU policies and laws. When taken together with the relatively weak public health competence, this creates a tension in relation to improving public health (64).
- This is manifested when a Member State wishes to impose measures which would benefit public health, but could be construed either as interrupting the single market in (for example) tobacco or alcohol sales, or food marketing, or as undermining the Common Market Organisation under EU agricultural policy.
- This has occurred on a number of occasions: in the 1990s when Sweden acceded to the EU and there was a challenge to its alcohol monopoly (65); more recently to the UK when Scotland proposed the introduction of a minimum unit price for alcohol (66); similarly to Denmark in relation to its ban on trans fats (67), and to a recent recommendation from the EU to Finland to repeal a confectionary tax (68).
- Although public health has often prevailed in the legal challenges based on internal market regulations, with the European Court of Justice consistently applying the Treaty provision requiring the EU to incorporate a high level of health protection in all its policies, the difference in power between the rules on the functioning of the market, and the article on protection of the public, demonstrates that far from being less involved in the EU, there is a strong argument for the UK public health community to not only become more involved in the development of EU policy, but also to advocate for a leading role for the UK government in ensuring that Europe continues to prioritise the health and well-being of its population.
- Some commentators have argued for Brexit as a means of being exempt from the Transatlantic Trade and Investment partnership. However, the EU’s negotiating position (69), just published, shows how it has accepted many of the arguments from the public health community, especially with regard to the controversial Investor State Dispute Resolution mechanism. Specifically, the EU is arguing for open procedures (70), with all papers posted on the internet, decisions by judges based on the law rather than by arbitrators chosen by the parties, and measures to prevent conflicts of interest by the judges. Outside the EU, the UK would almost certainly wish to negotiate a separate trade agreement with the USA but it is unlikely that it would either argue for or, even less likely, achieve, such favourable terms.
- Conclusions
The UK can currently boast world class public health, both practice and research. However, that is now threatened. Analysis of the complex factors and situations outlined above can be summarised very simply. Exit from the EU would be detrimental to the health of the UK population, a hindrance to effective public health practice and a grievous blow to UK research.
If the UK leaves the EU, our excellent public health practice and research will be severely damaged for many years to come. Separated from the EU, the UK on its own would lose the capacity to effectively control many of the most important determinants of our current and future health. These include pandemics, the environment, healthy sustainable food, and, perhaps most significantly, climate change.
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