High Level Of Health Protection Research Articles

Can EU Law Be Used to Challenge Better Regulation Practices That Do Not Lead to Better Health?

Legislation produced under the EU Commission's Better Regulation Agenda sometimes fails to achieve the Treaty obligation to ensure a high level of health protection in all EU policies and activities. Public health advocates have raised the question of whether EU law can be employed to challenge this apparent breach of Treaty obligations at the proposal preparation stage, compelling the Commission to amend prospective EU legislation so that it better protects health. This article will demonstrate that unfortunately this is not possible due to the justiciability of both Article 168 TFEU and the Better Regulation Agenda. However, this awareness can help public health advocates to re-focus their efforts on strategies that will likely have a greater impact in swaying the direction of EU health policy.

Protecting noncommunicable disease prevention policy in trade and investment agreements.

Preventing noncommunicable diseases is a global priority, for which the World Health Organization has recommended policies to reduce the consumption of tobacco products, alcohol and unhealthy foods. However, regulation has been strongly opposed by affected industries, who have invoked the provisions of legally binding trade and investment agreements. The aim of this analysis of the legal, economic and public health literature was to present a short primer on the relationship between noncommunicable disease prevention policy and trade and investment agreements to help public health policy-makers safeguard public health policies. The analysis identified opportunities for protecting, and even promoting, public health in trade and investment agreements, including: (i) ensuring exceptions for public health measures are included in agreements; (ii) committing to good regulatory practice that balances transparency and cooperation with the need for governments to limit the influence of vested interests; (iii) ensuring trade and investment agreement preambles acknowledge the importance of public health; (iv) excluding investor–state dispute settlement mechanisms from agreements; and (v) limiting the scope and definition of key provisions on investor protection to reduce the risk of investment disputes. This synthesis of the multidisciplinary literature also provides support for greater strategic and informed engagement between the health and trade policy sectors. In addition, ensuring a high level of health protection in trade and investment agreements requires cooperation between disciplines, engagement with experts in law, economics and public health policy, and fully transparent policy processes and governance structures.

The EU Response to COVID-19: From Reactive Policies to Strategic Decision-Making.

The EU Response to COVID-19: From Reactive Policies to Strategic Decision-Making.

Risk mitigation for indoor air quality using the example of construction products – efforts towards a harmonization of the health-related evaluation in the EU

In Europe, the Construction Products Regulation sets harmonized conditions for the marketing of construction products with the objective of protecting the building users' health. Until now only three European countries have implemented requirements for the assessment of VOC emissions from construction products. Therefore, the European Commission is planning the issue of a delegated act on the communication of VOC emissions from construction products in the form of VOC classes. A key prerequisite for defining the VOC classes is the completion of the EU-LCI list currently being carried out by a group of experts from ten European countries. This paper reports on the development of the VOC class concept, the progress of the EU-LCI harmonization framework and Germany's current efforts to ensure a high level of health protection for building users and avoid dangers from construction product emissions.

‘Choking smokers, don’t you think the joker laughs at you’: European Union competence and regulation of tobacco products packaging under the new Tobacco Products Directive

Directive 2014/40 updated and repealed Directive 2001/37. As with the previous Directive, the new Tobacco Products Directive’s legal basis, proportionality, and subsidiarity were at issue in three recently decided cases, an action for annulment and two preliminary rulings, upholding the Directive’s validity, as well as in another pending preliminary reference. The new TPD once again raises questions of EU competence and recourse to the Article 114 TFEU general internal market legal basis for health measures. This article examines the dual nature of internal market legislation and interaction between internal market and public health objectives, analysing means of justifying the legal basis and proportionality of health-related internal market measures: the high level of health protection envisaged by mainstreaming provisions and the ‘decisive factor’ formula; the EU legislature's discretion as to the most appropriate method of approximation; and its broad discretion in areas involving complex assessments. This article examines the legal basis, proportionality, extent and relevance of labelling and packaging provisions on health warnings, TNCO labelling, misleading features and packet standardization. It suggests further adaptation of the public health legal basis, to reflect the evolution of EU competences in practice and avoid contrived reliance on the internal market objective, which should not, however, entail excessive risk-regulation.

Promoting Human Health and the Functioning of the Internal Market: The Reaffirmation of the Tobacco Products Directive’s Key Objectives in Poland v. Parliament and Council, Pillbox 38 and Philip Morris Brands and Others

The regulation of tobacco in the EU has a history of tough negotiations and legal challenges and the new 2014 Tobacco Products Directive has already proven to be no exception. Striving to promote the functioning of the internal market, yet at the same time maintain high level of health protection, this piece of legislation proliferated from international standards under the World Health Organization (WHO) Framework Convention on Tobacco Control and introduced more stringent marketing requirements for tobacco and its products than its predecessor. However, the Directive was immediately challenged by the industry and some Member States, which claimed that the new requirements on packaging and labelling as well as trade of tobacco and related products were inconsistent with the primary law. This analysis provides an insight into three recent parallel judgments of the European Court of Justice in cases Poland v. Parliament and Council, Pillbox 38 and Philip Morris Brands and Others, which upheld the legality of the Tobacco Products Directive and reaffirmed the importance of preserving the balance between the smooth functioning of the internal market and the promotion of human health within the EU.

Amending UN drug treaties to allow member states self-determination

Purpose – This paper aims to analyse the fundamental principles of the main international conventions against use of drug and to verify if it would be preferable to let European Member States adopt specific measures according to own needs at a national level. Design/methodology/approach – The research uses a comparative approach by examining the different national legislations in respect of the discipline of the international conventions for finding analogies and differences between them. Findings – The research has discovered a wide variation in the criteria for triggering a legislative response and in the penalties for non-compliance. Nevertheless, there seems to be a trend towards countries focusing on penalising supply rather than possession of these substances. Research limitations/implications – To maintain a common international level in fighting against the use and commerce of drug to enforce the effectiveness of national regulations. Practical implications – The achievement of a high level of health protection, well-being and social cohesion to prevent and reduce drug use, dependence and drug-related damage to health and society. Social implications – To ensure a high level of security for the general public by taking action against drug production, cross-border trafficking in drugs and the diversion of chemical precursors used in drug production, as well as by intensifying preventive action against drug-related crime through effective cooperation, embedded in a joint approach. Originality/value – This is a fast-moving area of law, which continues to evolve for the different new substances being introduced in international drug traffic, so different solutions to the problem can be found by national legislators who need to be coordinated at an international level.

Nouvelle approche de la gestion des risques microbiologiques dans les aliments

The aim of the food legislation is to ensure the protection of human health. Traditionally, the food legislation requires food business operators to apply good hygiene practices and specific procedures to control foodborne pathogens. These regulations allowed reaching a high level of health protection. The improvement of the system will require risk-based approaches. Firstly, risk assessment should allow the identification of high-risk situations where resources should be allocated for a better targeting of risk management. Then, management measures should be adapted to the health objective. In this approach, the appropriate level of protection is converted intofood safety and performance objectives on the food chain, i.e., maximum microbial contamination to fulfil the acceptable risk level. When objectives are defined, the food business operators and competent authorities can identify control options to comply with the objectives and establish microbiological criteria to verify compliance with these objectives. This approach, described for approximately 10 years, operative thanks to the development of quantitative risk assessment techniques, is still difficult to use in practical terms since it requires a commitment of competent authorities to define the acceptable risk and needs also the implementation of sometimes complex risk models.

Creating Conditions for the Success of The French Industrial Advanced Therapy Sector

Although the European Union merely followed the initiatives of the United States and Japan by introducing special regimes for orphan medicinal products, it has introduced a special status for a new category of biological medicinal products, advanced therapy medicinal products (ATMPs), adopting specific associated regulations. European Regulation (which constitutes the highest legal instrument in the hierarchy of European law texts) [EC] No. 1394/2007, published in 2007, uses this term to define somatic cell therapy medicinal products, tissue-engineered products, and gene therapy medicinal products, possibly combined with medical devices. The stated objective was two-fold: both to promote their industrialization and market access, while guaranteeing a high level of health protection for patients. Since publication of the regulation, few marketing authorizations have been granted in Europe, and these have not been accompanied by commercial success. However, certain recent studies show that this is a growing sector and that France remains the leading European nation in terms of clinical trials. This round table brought together a panel of representatives of French public and private protagonists from the advanced therapy sector. The discussions focused on the conditions to ensure the success of translational research and, more generally, the French advanced therapy sector. These enabled a number of obstacles to be identified, which once lifted, by means of recommendations, would facilitate the development and success of this sector.

New regulations on medical devices in Europe: what to expect?

Medical devices (MDs) contribute to improve quality and effectiveness of healthcare. The MD industry is a heterogeneous, innovative, dynamic and growing sector. The existing regulatory framework for MDs has been in place for 20 years and needed a revision. In September 2012, the European Commission published a proposal for a new regulation on MDs which was amended by the Parliament in October 2013. This new regulation aims to harmonize practices, increase transparency and guarantee a high level of health protection. We conducted an analysis of the proposal to highlight the major upcoming changes.

Food Safety in the Czech Republic

Food Safety can be understood from many points of views: from the State\'s obligation to create a legal environment for the production, import and inspection of health safety food to the contents of the individual, even exceeding the legally laid limits or added substances in food. While the first aspect is given by law and therefore is easily controllable, the second is more subjective, poorly clearly verifiable and is part of continuing discussions, both professional and lay public.If the all requirements for the production, distribution and sale are fulfil in accordance to legislative, food in market can be considered such as health and safety food. From 1st May 2004 The Czech Republic became an equal member of the European Union which has led to the adoption of all rules of this Community. One of the basic obligations enshrined in the Treaty establishing the European Community is to guarantee a high level of health protection and strengthen consumer protection.

Logistik und europäische Gesetze für allogene Gewebetransplantate

European rules stipulate quality and safety requirements on recruitment, testing, preserving, and distributing human tissues for application in patients in order to obtain a high level of health safety. In order to avoid transmissible diseases in tissue transplantation, specific requirements for all individual groups of tissues of human origin were defined. European Member States need to implement these directives in order to obtain a high level of health protection in human application. Precise instructions for tissue institutes regarding organization, management, documentation, and quality controls are required. Adverse effects have to be registered by these institutions. Costs need to be contained and therefore uniform administrative directives will engineer the modern techniques of communication. A uniform European code is needed for easy traceability of human tissues. The directive respects the basic human rights as laid down in the Charter of Fundamental Rights of the European Union.

Presence of mycotoxins in food: Can we use the data from the EU Rapid Alert System for quantitative risk assessment?

Mycotoxins are natural compounds that may cause various adverse toxicological manifestations in humans and animals. The nature, the severity and scope of their adverse activity are varied and in general, even in small amount they have potent carcinogenic, genotoxic effect and injure the immune system. In order to provide high level of health protection for consumers, the European Union has established strict regulatory limits, whose implementation is enforced.The EC (2001) Commission Regulation sets maximum levels for some mycotoxins in foodstuffs: for aflatoxins, ochratoxin A, patulin, deoxynivalenol, zearalenone, fumonisins, T-2 and HT-2 toxins. Particular product categories are regulated under specific decisions ordaining control of imported consignments at the point of entry. Due to the fact that only aflatoxins are addressed in the specific decisions, they are the mostly detected and notified mycotoxins in the EU Rapid Alert System for Food and Feed (RASFF). The second most frequent group, Ochratoxin A is typically detected during internal EU market controls. Most RASFF notifications concern product categories falling under specific EU decisions, especially the Aflatoxin content of nuts and nut products. Significant amount of aflatoxins can be found also in dried fruits, spices and herbs.The article reviews and analyses the data available in rapid alert system concerning mycotoxins notification, and evaluates the usefulness of this information for risk assessment. The value of RASFF system is unquestionable and it fulfils its intended function included in its name. The system is a significant source of valuable information, but for risk assessment purposes, other additional information is needed. It could be used most effectively for risk assessment, if it was to provide data on the ratio of all/tested/positive lots and if the authorities provided not only the positive results, but also the exact mycotoxins level of every analysed sample.

Health policy and European law: Closing the gaps

Health policy in the European Union has, at its centre, a fundamental contradiction. On the one hand, recent Treaties, which are the definitive statements on the scope of European law, state explicitly that health care is a responsibility for Member States. On the other hand, as health systems involve interactions with people, goods and services, all of whose freedom to move across borders is guaranteed by the same Treaty, it is increasingly apparent that many of their activities are subject to European law. Moreover, there is now compelling evidence that health care makes an important contribution to overall population health. The goals of the European Union are both economic and social and, since the Treaty of Maastricht, it has been required to ‘contribute to the attainment of a high level of health protection’. It is not possible to do this without ensuring that health systems are providing effective care to their populations. Another issue is that the European Union has, as one of its fundamental principles, an imperative to promote the free movement of people. The twin challenges of ensuring that health systems promote a high level of health and that they facilitate the mobility of Europe’s citizens pose certain problems. Reflecting the societal preferences of their citizens, member states have chosen different ways to organize their health care systems. These choices reflect many factors. The ways in which varying goals are achieved reflects differing views about the legitimacy of regulation, incentives, and other levers to bring about change. Health care systems across states reflect national culture, institutional frameworks, and contemporary political choices, and there is no obvious reason to seek to harmonize systems. Because of this, the application of a uniform legal framework, as set out in the EU Treaties, will inevitably be problematic. But at the same time, health care cannot be ignored by European legislators. Many of the things upon which Europe depends, such as pharmaceuticals or technology, are internationally traded and health care workers also have free movement between states. So there is a paradox. Health systems in Europe are diverse, yet they are also interdependent. In themselves, they are exempt from European law, yet almost everything they do, and those elements that are essential for them to function, are governed by it. ARTICLE IN PRESS

IVD industry role for quality and accreditation in medical laboratories

Manufacturers of in vitro diagnostic (IVD) medical devices and laboratory management have become integral partners in building and improving the quality of laboratory services. There is an increasing awareness that quality is inherent in the design of any reagent or analytical system. In vitro diagnostic medical devices should provide patients, users and third parties with a high level of health protection. Therefore, both manufacturers and users must work in partnership for continual improvement. For manufacturers, standards such as ISO 9000 already exist to guide applications of quality practices. In the field of laboratory medicine, the availability of a specific, universal standard (ISO/DIS 15189) for quality management in medical laboratories will represent a great opportunity for harmonising medical laboratories at an international level. In addition, accreditation of medical laboratories according to the proposed ISO 15189 standard can help develop the relationships between laboratories, and the biological follow-up of travelling patients. Manufacturers are able to help laboratory management to reach a high level of quality, not only by providing high value products, but also on the basis of their own experience of ISO 9000 certification.

Old World News: Divide and Rule

English Channel has long been the great divide in Europe, as shown in the prewar newspaper headline: FOG IN CHANNEL; CONTINENT CUT OFF. divide is not only a matter of geography, nationality, and language, but of all sorts of subtle differences in culture as well, including medical culture. Little was done in the first four decades of the European Community (EC) to try to bring together the different medical cultures of member states. Health care was not mentioned in any of the basic treaties, although reciprocal arrangements to provide treatment for citizens of other EC states were developed. Only in the 1991 Maastricht treaty was there for the first time specific mention of the Community's role in promoting public health. Title XV of the treaty, entitled Public Health, begins: The Community contributes to the maintenance of a high level of health protection by encouraging cooperation between the member states and, if necessary, by supporting their actions. Whether any such cooperation can be further developed depends on what, if anything, can be salvaged of the Maastricht treaty now that the Danish people have rejected it by referendum. Obviously some forms of cooperation already exist independent of the EC and its commission. EC cooperation, on the other hand, has so far mostly been in medical research projects. Yet these illustrate the Community's talent for giving confusingly mixed signals: just as the commission announced a large increase in the funds available for medical research, it also issued a draft directive on data protection that could severely curtail some areas of research. There are various levels of advice, instructions, and directives that the commission may promulgate. first statement on medical research, for example, was issued in 1990 as guidelines, Good Clinical Practice for Trials on Medicinal Products in the European Community.[1] As guidelines they have no legal force anywhere in the Community, although drug companies that do not comply with them may find it increasingly difficult to have new products licensed in member states. When issued, however, it was intended that the guidelines become a directive this year. As a directive they would have to be subsumed, within a limited period, into the national law of each member state. There may be some hesitation, however, about giving the guidelines the force of law, perhaps related to the French experience. A law to protect subjects of biomedical research that came into force in France in 1990 created several new criminal offenses, such as performing research without the subject's consent, or without prior approval by an ethics review committee.[2] It has greatly increased the pressure on those committees, resulting in many resignations, including one of a whole committee. …

Divide and Rule

English Channel has long been the great divide in Europe, as shown in the prewar newspaper headline: FOG IN CHANNEL; CONTINENT CUT OFF. divide is not only a matter of geography, nationality, and language, but of all sorts of subtle differences in culture as well, including medical culture. Little was done in the first four decades of the European Community (EC) to try to bring together the different medical cultures of member states. Health care was not mentioned in any of the basic treaties, although reciprocal arrangements to provide treatment for citizens of other EC states were developed. Only in the 1991 Maastricht treaty was there for the first time specific mention of the Community's role in promoting public health. Title XV of the treaty, entitled Public Health, begins: The Community contributes to the maintenance of a high level of health protection by encouraging cooperation between the member states and, if necessary, by supporting their actions. Whether any such cooperation can be further developed depends on what, if anything, can be salvaged of the Maastricht treaty now that the Danish people have rejected it by referendum. Obviously some forms of cooperation already exist independent of the EC and its commission. EC cooperation, on the other hand, has so far mostly been in medical research projects. Yet these illustrate the Community's talent for giving confusingly mixed signals: just as the commission announced a large increase in the funds available for medical research, it also issued a draft directive on data protection that could severely curtail some areas of research. There are various levels of advice, instructions, and directives that the commission may promulgate. first statement on medical research, for example, was issued in 1990 as guidelines, Good Clinical Practice for Trials on Medicinal Products in the European Community.[1] As guidelines they have no legal force anywhere in the Community, although drug companies that do not comply with them may find it increasingly difficult to have new products licensed in member states. When issued, however, it was intended that the guidelines become a directive this year. As a directive they would have to be subsumed, within a limited period, into the national law of each member state. There may be some hesitation, however, about giving the guidelines the force of law, perhaps related to the French experience. A law to protect subjects of biomedical research that came into force in France in 1990 created several new criminal offenses, such as performing research without the subject's consent, or without prior approval by an ethics review committee.[2] It has greatly increased the pressure on those committees, resulting in many resignations, including one of a whole committee. …