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Introduction
The European Union is a relatively new formation. This implies that each social sphere in the countries of the EU has changed one way or another as the states need to come to a common social system that will work effectively in every member-country of the Union. Moreover, because the general aim of the EU was, originally, to unite the nations (economy is the major aspect of the unification process), it is obvious that different social fields should, at least, in some aspects, function in similarly in the European level. In this respect, the main objectives of this work are 1) to discuss how the EU has been enabled to improve the human health in the recent years and 2) to observe the most significant obstacles that constrain the EU from performing the former task. The area under consideration is organ donation.
How Has the EU Been Enabled to Improve the Human Health?
The European Union is a conglomerate that is governed by its own fundamental laws. The Treaty on the Functioning of the European Union (TFEU) says the nations and the EU share their competences in many fields, public healthcare among them. 1 It implies that the authorities of the EU have to consider national interests and opinions. 2 Without coordination, no common measures in any sphere are possible.
Firstly, it is necessary to discuss the European Union Health Law. It is logical that a country or a group of nations closely connected to each other should have a special law that regulates the health protection area. On the one hand, it exists, on the other, it does not. According to Tamara K. Hervey and Jean V. McHale, “the EU’s legal order is relatively unstable, certainly when compared to the constitutional settlements of its Member States… what is needed is an understanding of EU law as a process.” 3 It means that the Health Law was not formed at once: the process has been on for decades and is continuing. It consists both of legislation and case laws.
There are always new treaties between the Member Countries that contribute to the Health Law. Although its form is not perfect, still the existing of a united legal base, the recognition of the Law’s existence, and the mutual urge to develop it further give opportunities to improve the human health in the whole Europe. Further on, the TFEU states that its policy “shall be directed towards improving public health, preventing physical and mental illness and diseases, and obviating sources of danger to physical and mental health.” 4 To fulfil this purpose, there is a need to implement, support, and develop a law that would regulate the health-protection system.
It is worth consideration how the European Health Law impacts the area of organ transplantation. According to Rory Watson, “while organ transplants are an established medical practice, queues are long and donation rates vary considerably across Europe.” 5 This is a description of the situation in 2010. In this case, there should be a law regulating the organ donation in the whole European Union. Consequently, after a lengthy discussion, such an act was adopted. Its main aim was to reduce the queues. There is a tendency that in a number of countries, citizens donate more organs than in others. Queues should be reduced in the countries lacking in donated organs. This measure perfectly corresponds to the principles of the TFEU that declares equality and non-discrimination.
The second aspect of how the EU has been enabled to improve the state of the health-protection system is combating illegal medical services, which used to be widely spread in the Eastern-European Member States. This is a burning issue, especially in the situation with the unequal amount of donated organs in the countries. This inequality causes the demand for illicit traffic of implants. According to the TFEU, “measures setting high standards of quality and safety of organs and substances of human origin, blood and blood derivatives” should be taken. 6 In case of illegal organ trading, one cannot expect any high standards. Moreover, criminals may obtain people’s organs against their will. Thus, it is a serious crime in all of its aspects, and it should be combated. The unified donation system may, at least, partly, remove the ground from under the illicit market.
Not only the TFEU and donation-regulating laws are aimed at achieving this goal. Also, there is the Council of Europe Convention against Trafficking in Human Organs. According to the document, its purpose is to resist the illegal taking of organs, their usage as implants, and the violation of national laws in the field. 7 The Convention also considers such matters as giving protection and help to the victims of illicit organ extraction. It is significant that the document suggests strict measures against legal organizations and their employees involved in organ-trading. This gives the society hope that the illegal activity will be punished adequately, and a reduction in the crime will be observed soon.
Further on, the Directive on Standards of Equality and Safety of Human Organs Intended for Transplantation states measures should be taken to minimise the risks of transplantation. 8 The Action Plan on Organ Donation and Transplantation is aimed at making the organ availability higher, transplantation services more accessible, and procedures safer. 9 These are important documents directed at improving the state of the medical sphere under consideration.
During the last two decades, the EU has been implementing the system of the so-called ‘soft economic governance.’ This instrument is being applied to various spheres including healthcare. Katherine Fierlbeck describes the open method of coordination (OMC), which means that the general strategic issues are solved by the EU, more specific objectives are pronounced by the Ministerial Council, and then, national governments put the ideas into practice. 10 As an outcome, they make reports of what is applicable and what is not. Thus, the EU has an opportunity to correct and improve the strategies. Special attention should be paid not only to improving the healthcare system but also to developing it. In this respect, it is necessary to support the area of medical research.
The OMC gives an opportunity to accomplish both goals. On the one hand, this approach helps improve the quality of public medical services. Reporting mistakes and correcting them without delays are crucially important tasks in such complex spheres as organ donation and transplantation. Furthermore, the measure allows reducing bureaucracy. It may release new financial resources for research and give it an impulse. Scientific studies are especially significant for such problematic medical branches as implantation. In such spheres, there is constantly a strong need for new methods, technologies, skills, and equipment.
The statistics show that step by step, the situation in organ donating improves. This may be viewed in the monthly statistics of Eurotransplant. 11 This organisation works on transplanting organs in several European countries such as Austria, Germany, Belgium, Croatia, Slovenia, Luxembourg, and the Netherlands. The tendency demonstrated by the statistics shows that the methods used by the EU to improve the public healthcare are, in general, successful. However, there are some barriers constraining the progressive policies from achieving better results than those which may be observed nowadays.
Obstacles
As for barriers in establishing and developing the unified donor organ system in the EU, the first one of them is that there are still contradictions between the Member States, even in such a ‘risky’ sphere as medical treatment. For example, from Case C-380/03, one may learn that in 2006, an argument between Germany and the European Union occurred that concerned the law against tobacco advertising. 12 The act was meant to significantly restrict the right to advertise tobacco products. It also concerned sponsoring tobacco ads. Germany refused to obey the new directive as it contradicted some of its national acts. The country appealed to the Court of Justice of the European Union, whose competences are stated in article 267 of the TFEU.
The situation resulted in a lawsuit which cancelled the directive and allowed to adopt it only in a much milder version. In fact, the court stated that the community has no right to regulate national markets. 13 Although this case does not concern organ donation directly, it serves as a vivid illustration of how contradictions between one country and the Union lead to undesirable consequences like canceling a legal act that concerns not only one state but many of them. The TFEU declares equality and cooperation in the sphere of health protection. 14 However, in reality, it may be hard to establish cooperation as national legal systems may contradict each other as well as they may be contrary to European acts.
The next obstacle is that the cost of public health services may rise significantly. According to Greer, “it is also now about the extent of government expenditure and to a changing degree the specific health policies and priorities of member states.” 15 The TFEU states that it aims at improving public medical services. 16 However, the document does not mention that the new system requires new financial resources gained from tax-payers. In the countries of the EU, the public systems of health protection are already relatively developed and need a large amount of investments from taxes. If more significant investments are required both from the national budget and the common one, governments will have to either reduce the expenditures on some other social spheres or to raise taxes. Thus, the measure may be unpopular among tax-payers and meet strong opposition. It may also cause a fall in the effectiveness of investments in other spheres besides public medical services. Moreover, organ transplantation is a specific and complicated area that requires more investments than many other branches of medicine.
Further on, one should not miss the factor of objective distinctions between European countries. Despite the fact that the EU is a united structure, its members still have differences which are sometimes huge. The variations concern the level of economic development, religion, culture, science and, no doubt, public healthcare. In some places, the level of education is not sufficient for the majority of the population to understand the necessity of developing such spheres as resuscitation, organ donation and transplantation. A lot of people are still suspicious of these practices and have an opinion that taxes should not be wasted on them. The public opinion influences the activity of the government and its priorities. That is why the sphere does not get enough financial support.
It is a serious obstacle that prevents relatively new branches of medicine from moving forward. The objective of eliminating this obstacle fully corresponds to the principles declared by the TFEU (namely, “health information and education” 17). It means that educational institutions and programs should be improved to rid the majority of their prejudices and give citizens an impulse to support perspective and innovative methods of saving people’s lives and healths.
To add, the systems of managing human materials differ in the countries of the EU. For example, Germany and Great Britain use the principle of informed consent while Portugal and Belgium operate with that of the presumed one. 18 In the national framework, the systems have been existing for three or four decades while the strategies of the EU in the area started to form only in the 2000s. Bringing all the approaches to conformity needs time, agreements, and legislative measures. However, the basic document called the Treaty on European Union declares that the EU’s functioning is based on the principles of conferment and proportionality. 19 It means that the EU’s government is formed by the nations directly. Moreover, the Treaty declares the priority of national identity. This is a natural contradiction which is hard to overcome, but measures should be taken to reach agreements in the sphere of public healthcare.
Another issue arisen by the TFEU is preventing diseases. 20 It includes not only preventive measures against illnesses but also diminishing the risks for donors and the donated. According to the Convention of Human Rights and Biomedicine, “scientific research in the field of biology and medicine shall be carried out freely, subject to the provisions of this Convention and the other legal provisions ensuring the protection of the human being.” 21 To make the donor and the person with a donated organ enjoy life, the specialists should be one hundred percent sure that they conduct operations and treatment correctly.
Moreover, there is a strong need to monitor the patient’s state after all the procedures have been performed. If complications are observed, they should be thoroughly analysed. That will not only help the patient but also stimulate the development of the whole branch. This is an important task which needs qualified scientific research. Moreover, a system of scientific patient monitoring (also research-based) should be formed. It will give an opportunity to compare results, make statistics, and draw correct conclusions. The EU needs to develop and adopt acts to solve this issue.
Summary
In this work, it has been analysed what the European Union has already done to improve public healthcare in its countries. The organ-donation branch serves as an illustrative example. Firstly, the Treaty on the Functioning of the European Union (TFEU) was adopted. It settles the most important strategic tasks for the system. Secondly, the TFEU is supported by the system called the European Union Health Law. Although it does not exist as a written act, it combines legislative documents and case laws. On the one hand, it may be difficult to use. On the other, it is flexible and changes constantly according to the situation. Thirdly, there is a law that regulates organ donation in general. It may help reduce the queues for donated organs in some countries of the EU. Fourthly, the Council of Europe Convention against Trafficking in Human Organs was adopted. It suggests effective measures against illicit trading and transportation in the area. Finally, the open method of coordination (OMC) was implemented. It helps reduce bureaucracy in the sphere of patient treatment, correct mistakes in a short time period, and give an impulse to medical research. All these acts and measures have proved to be effective. However, the situation is far from perfect, and there are obstacles constraining them from reaching effectiveness.
On the one hand, there are contradictions between national and European laws that sometimes hamper the implementation of effective measures. The second obstacle is that it may be hard to find financial sources to make improvements. The third one is that there is the lack of education in such problematic fields as implantation and organ donation, and it forms a partly negative public attitude to them. Moreover, the policies of managing human materials in the Member States were adopted much earlier than those in the EU, and bringing them to conformity may cause serious difficulties. Finally, it is urgent to have a well-coordinated system of monitoring the outcomes of medical procedures.
Bibliography
Primary Sources
Statutes and statutory instruments
- Consolidated Version of the Treaty on European Union 2012.
- Consolidated Version of the Treaty on the Functioning of the European Union 2012.
- Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine 1997.
EU Legislation and cases
- Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on Standards of Equality and Safety of Human Organs Intended for Transplantation.
- Action Plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States.
- Council of Europe Convention against Trafficking in Human Organs, Santiago de Compostela, 25.III.2015.
- Case C-380/03, Federal Republic of Germany v. European Parliament and Council of the European Union (Tobacco Advertising II). Judgment of the Court (Grand Chamber) of 12 December 2006, [2006] ECR I-11573.
Secondary Sources
Books
TK Hervey and JV McHale, European Union Health Law: Themes and Implications (Cambridge University Press, 2015).
Contributions to edited books
Derrick Wyatt, ‘Community Competence to Regulate the Internal Market’ in Michael Dougan and Samantha Currie (eds), 50 Years of European Treaties (Hart Publishing 2009).
Journal articles
- Scott L. Greer, ‘The Three Faces of European Union Health Policy: Policy, Markets, and Austerity’ (2017) Policy and Society, vol. 33
- Katherine Fierlbeck. ‘The Changing Contours of Experimental Governance in European Health Care’ (2014) Social Science & Medicine, vol. 108
- Rory Watson, ‘Pan-European organ transplant scheme promises to cut waiting times’ (2010) British Medical Journal, vol. 340
Websites
Eurotransplant, ‘Monthly Statistics’ . Web.
Footnotes
- Consolidated Version of the Treaty on the Functioning of the European Union 2012, article 4.2.
- Consolidated Version of the Treaty on the Functioning of the European Union 2012, article 5.1.
- Tamara K. Hervey and Jean V. McHale, European Union Health Law: Themes and Implications (Cambridge University Press, 2015) 30.
- Consolidated Version of the Treaty on the Functioning of the European Union 2012, article 168.1.
- Rory Watson, ‘Pan-European organ transplant scheme promises to cut waiting times’ (2010) British Medical Journal, vol. 340, 1160, 1160.
- Consolidated Version of the Treaty on the Functioning of the European Union 2012, article 168.4a.
- Council of Europe Convention against Trafficking in Human Organs, Santiago de Compostela, 25.III.2015.
- Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on Standards of Equality and Safety of Human Organs Intended for Transplantation.
- Action Plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States.
- Katherine Fierlbeck. ‘The Changing Contours of Experimental Governance in European Health Care’ (2014) Social Science & Medicine, vol. 108, 89, 92.
- Eurotransplant, ‘Monthly Statistics’. Web.
- Case C-380/03, Federal Republic of Germany v. European Parliament and Council of the European Union (Tobacco Advertising II). Judgment of the Court (Grand Chamber) of 12 December 2006, [2006] ECR I-11573.
- Derrick Wyatt, ‘Community Competence to Regulate the Internal Market’ in Michael Dougan and Samantha Currie (eds), 50 Years of European Treaties, 94.
- Consolidated Version of the Treaty on the Functioning of the European Union 2012, article 168.2.
- Scott L. Greer, ‘The Three Faces of European Union Health Policy: Policy, Markets, and Austerity’ (2017) Policy and Society, vol. 33, 13, 13.
- Consolidated Version of the Treaty on the Functioning of the European Union 2012, article 168.1.
- Consolidated Version of the Treaty on the Functioning of the European Union 2012, article 168.1.
- Tamara K. Hervey and Jean V. McHale, European Union Health Law: Themes and Implications (Cambridge University Press, 2015) 358.
- Consolidated Version of the Treaty on European Union 2012, articles 4-5.
- Consolidated Version of the Treaty on the Functioning of the European Union 2012, article 168.1.
- Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine 1997.
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