The Foreign Secretary launched the balance of competence review in July 2012, taking forward a coalition commitment to examine the balance of competences between the UK and the European Union. The review will provide an analysis of what the UK’s membership of the EU means for our national interest.
The Department of Health is conducting a review into EU competences related to health and launched its public call for evidence. The call for evidence period has involved engagement with the public, the health sector, food sector, devolved administrations and EU partners and stakeholders. Following the call for evidence, the Department will publish a full report on EU competence in health, which will provide a more thorough legal analysis, taking into account the range of evidence presented.
It is important that the report includes evidence from a wide range of interested parties, to ensure a comprehensive and thorough analysis of the impact of EU competence in health in the UK. As an organisation with relevant knowledge, expertise and experience in the field, the Department hoped that the College would feel able to contribute evidence, both on the overall position of the EU’s health competence as well as on the specific areas of competence outlined in the call for evidence, which range from medicines and medical devices to nutrition and food labelling.
The health report links into the other balance of competence reports examining different areas of EU competence. Full details of the other reports and the balance of competence review as a whole can be found on the Foreign and Commonwealth Office website at: https://www.gov.uk/review-of-the-balance-of-competences.
Comments on Department of Health Review of the Balance of Competences: Health - Call for Evidence
The Royal College of Physicians of Edinburgh (“the College”) is pleased to respond to the Call for evidence on the Government’s review of the balance of competences between the United Kingdom and the European Union regarding health.
The College has the following comments on specific questions:
Impact on the national interest
How does the EU’s competence in health affect you/your organisation?
The EU’s competence in health affects the College in a variety of ways. Examples of areas under EU jurisdiction which affect the College include:
Regulatory matters:
- An effective and timely warning system across EU member states to indicate restrictions on practice and removal of professional registration;
- Testing of language skills and mobility of health professionals across EU member states: there are a number of implications for patient safety in this area.
- Competent English language skills for doctors working in the UK need to be supplemented with good communication skills and cultural awareness.
- Medicines and technology regulations, including packaging and supporting information including dosage – standardisation would reduce confusion caused by multiple formulations and packaging.
Training and Quality:
- Curricula leading to medical qualifications such as the Certificate of Completion of Training (CCT) across the EU states are not always comparable or transferable in the medical specialties and sub specialties;
- Restrictions on UK ability to change the length of medical training by specialty;
- The European Working Time Directive (EWTD): The EWTD has had unintended adverse consequences on both training and service. While the improvement in trainees’ work /life balance has been positive, it has had detrimental effects on continuity and quality of patient care and the training of junior doctors;
- Consistency of quality standards across EU member states: there is significant variation in health systems across the EU member states.
Public health matters:
Restraining measures on access to and consumption of tobacco and alcohol, and legislation on food regulation.
What evidence is there that EU action in health advantages or disadvantages:
- The UK national interest
The effect of EU action on health generally has a positive impact on the UK. Examples of this include social measures, health protection and security across borders.
Through the EU's various instruments and institutions, it assures basic standards in a number of respects, although the application of these standards needs to be equivalent across the European Union. There are examples of arbitrary or partial implementation, not least the most recent example of the introduction of horse meat into the beef food chain in countries across the European Union.
Negative effects include the inflexibility of the EWTD, where relaxation could improve continuity of patient care in the UK and the quality of medical training.
- Business and industry
No comment. - Patients and citizens
The UK benefits from EU action on public health, particularly relating to alcohol and food.
Please consider what evidence there is to demonstrate:
- the extent to which the EU’s role in public health supports member state actions effectively and efficiently
The EU's role, overall, is beneficial to public health. Through the creation of wealth, assured processes and supporting institutions, the EU can regulate a very large market in consumer products, so limiting related harm. However, it is clear that the failure on occasions to apply a proportionately common sense approach demonstrates the need for proportionality in assessing the risk and restricting market opportunities. The entry of horse meat into the beef food chain and the sourcing of fish from European waters, marketed through non-European intermediaries in the 1990s where the public health hazards were low, are good examples.
Generally, the role of the EU in health seems appropriate to support individual member states ie the focus is on areas where cross-border/supra-national action is appropriate for example, medicines, public health, nutrition, health screening, radiation etc.
- the opportunities and costs for the delivery of health and social care in the UK that flow from wider EU competences and policies such as the free movement of workers or the single market generally
No comment. - the extent to which EU competence and policies intended to allow EU citizens to access healthcare across the EU are effective and proportionate
No comment. - the extent to which health objectives are effectively and proportionately taken into account in wider EU policies
No comment.
Future options and challenges
How might the UK benefit from the EU taking more action in health?
Addressing health inequalities: These are more likely to be reduced by regulation, legislation and assurances that are applied equally to the whole population across the EU. This removes an element of voluntary activity but upholds the rights and interests of people who have the most to gain, whose choices are narrowest, and whose health is the poorest. There are numerous examples of health inequalities, and plenty of evidence and literature to underpin this principle.
Public health interventions: particularly in noting the importance of social determinants in creating health and balancing economic drivers and commercial interests. It could be perceived that the EU has a tendency to weigh in favour of business and commerce and, despite its commitment to consumer affairs and health (within the same Directorate), they often come second best to the interests of governments and private companies. A current example is the pressing need to reduce alcohol-related harm in high consumption countries such as Scotland, and the unfettered activities of food producers and retailers in promoting and sustaining over-consumption and unbalanced nutrition, with adverse effects on many consumers. Whilst competitiveness and free markets serve to drive up wealth and opportunity, it is well known that price and competitive pressures on potentially harmful substances that are legally marketed in the EU, such as alcohol and tobacco, require a firm and progressive framework of protections. The EU has embarked on a series of specific nutritional measures, e.g. on salt and fat, but more is required to reduce health related harm from over-nutrition as well as poor nutrition.
How might the UK benefit from the EU taking less action in health, or from more action being taken at the national rather than EU level?
One particularly important example might be the application of the EWTD to junior hospital doctors. There could be benefit if the application of the EWTD could be relaxed where there is clear evidence that it interferes with the quality of training and provision of safe patient care.
One of the few examples of public health benefit if the EU had less influence would be the removal of protection on alcohol minimum unit pricing allowing the UK to take unilateral action immediately to protect its citizens from excessive consumption of cheap alcoholic beverages.
How could action in this area be undertaken differently e.g.
- Are there ways of improving EU legislation in health, e.g. revision of existing legislation, better ways of developing future proposals, or greater adherence to the principle of subsidiarity and proportionality?
See above for the example of alcohol, and national restrictions or its actions to reduce alcohol related harm through restrictions on price and availability, currently in court and with the European Commission.
- Are there ways the EU could use its existing competence in health differently which would deliver more in the national interest?
No comment. - Could action be taken at any other international level i.e. by the WHO?
The WHO may set frameworks and encourage action but, without the legal frameworks of member governments and the European Parliament, their influence would be insufficient on matters such as tobacco control, alcohol and food. Nonetheless the influence of WHO drives European policy and stimulates national action. - What evidence is there on the relative merits of legislative and non-legislative measures in relation to health, and on how they are implemented?
There are plenty of national and international organisations that are able to advocate in a non-legislative manner in relation to health. It is essential that legislative bodies are able to act on recommendations that are binding on legislative and member states. However, measures are inadequate if enforcement, monitoring and effective sanctions fail.
The EU has a potential to narrow the gradient in health inequalities within member states and across the EU area. Its current redistributive policies serve to enhance this matter, and the EU may be able to influence the social determinants of health in a manner that would increase overall levels of health across populations.
The unforeseen consequences of EU Directives on specific applications require greater scrutiny and an ability to seek exemptions quickly as the EWTD and language issues for health clearly demonstrate.
The major risk of enlargement at present is that member states' institutions and resources may not have the ability to assure and comply with EU treaties and regulations, particularly in such areas as professional and medicines/devices regulation, the mobility of health care professionals and the recognition of training programmes.
- How else could the UK implement its current obligations?
No comment.
- What future challenge/opportunities might we face in EU health competence and what impact might these have on the national interest?
- What impact would any future enlargement of the EU have on health competence?
General
The document rightly states that representation in the EU and in international organisations such as WHO is at UK level. As the healthcare systems in the UK increasingly diverge, the practicalities of a single 'voice' from the UK are an area which would benefit from discussion. Stronger arrangements for devolved administrations to contribute to the single UK voice could be beneficial in more accurately representing the needs of the four nations of the UK.
No comment.
- Is there evidence of any other impacts resulting from EU action in health that should be noted?
Analysis of the legal annex (pages 29-44).
2. Medicines – the authorisation, free sale and purchase of medicines across the EU does promote appropriate safe treatment. However the diverse packaging and formulation of a particular drug means that appearances of medication can be different from one prescription to the next, and this can cause confusion to patients, as while the active ingredients are regulated, the presentation is not.
3.2 Medical Devices – clearly, strengthening controls, safety, transparency and surveillance of devices across the EU is highly desirable. It is not clear whether there is any common ground or discussion on equipment such as laboratory, radiology or endoscopy. Certainly, for endoscopic equipment, there seem to be significant variance in pricing structures in different EU countries.
4.4 Clarity is required that the surveillance of practices across the EU is sufficiently robust to ensure that the standards set are adhered to.
6.3 It is to be hoped that there will not be a significant delay beyond early 2013 in the adoption of the revised Directive concerning tobacco.
6.7 Since the Commission has been active in trying to reduce the number of smokers in the different EU countries, it would be helpful if comparative data could be detailed, country by country, of annual percentage reduction in smokers over the last 5 years.
7.1 The UK is currently exploring a minimum pricing strategy per unit in relation to alcohol, and it would be of great assistance in this important public health measure if EU legislation facilitated rather than obstructed such legislation.
The College supports the response from Scottish Health Action on Alcohol Problems (SHAAP) in relation to this, and along with other leading health groups, we are supportive of minimum unit price on the basis that price will impact on consumption, which will have a positive impact on public health. The EU has argued that minimum unit price would impinge on the free trade and unfairly disadvantage some producers. We are quite clear that the principle of protecting public health (Article 36) overrides concerns about free trade.
12.2 It is important that, particularly in the area of medical and surgical training, the EWTD is not required to be implemented rigidly in member states, such as the UK, where there is clear evidence that such a Directive interferes with the quality of training and subsequent safety of service provision.
13.2 Although the recognition of professional qualifications has been harmonised, the practice of medicine requires effective communication. Doctors wishing to work in the UK from outside of the EU are required to achieve a score of 7 or more in each of the domains of the IELTS exam, and this standard should be equally applicable to non-English speaking EU countries.
16.2 An eHealth network is commendable, and efforts should be made to co-ordinate any new initiatives. The College commends advancing UK national integration of IT systems before extending this into Europe.
- Are there any general points you wish to make which are not captured above?
- Are there any published sources of information to which you would like to draw our attention for the purposes of this review?