scholarly journals Supplementary patent protection and data exclusivity in the public health scope: legislation of Ukraine and the EU context

Author(s):  
T. Yu. Klochko
2021 ◽  
pp. 145507252199570
Author(s):  
Marjut Salokannel ◽  
Eeva Ollila

Background: Use of snus and snus-like nicotine products is increasing, in particular among young people, in several Nordic countries and Estonia, while snus is legally on the market only in Sweden and Norway. Snus is available in a great variety of tastes and packaging particularly catering for young users. Recently, strong snus-resembling nicotine pouches have emerged on the market. This research investigates the regulatory means to counteract this development. Methods: European Union (EU) and national tobacco control legislation, case law of the European Court of Justice (CJEU) and relevant public health studies are analysed. Results: The research finds that the judgement of the CJEU relating to the sale of snus on Finnish ferries has not been enforced. Permitted large traveller imports for personal use have contributed to wide availability of snus in Finland. Even if the legislation in Sweden is in conformity with the exemption it obtained in the Accession Treaty, the public health impact of snus use for young people in its neighbouring countries has become considerable. Nicotine pouches, -which are not regarded as medical products in terms of medicine legislation, lack harmonised EU-wide regulation. Controlling smuggling across open borders is challenging. Conclusions: The legislation at the EU and national levels should be able to protect young people from new tobacco and nicotine products. It is urgent to harmonise regulation relating to new tobacco and nicotine products taking as a base a high level of protection of health as required in the Treaty on the Functioning of the EU.


2007 ◽  
Vol 24 (4) ◽  
pp. 371-394
Author(s):  
Jenny Cisneros Örnberg ◽  
Hildigunnur Ólafsdóttir

The growth of the EU internal market has made it more difficult to maintain effective national regulation in the area of public health. The EEA agreement and EU membership of the Nordic countries resulted in the abolition of all of the monopolies on alcohol except at the retail level. The article examines how the Nordic alcohol retail monopolies have developed and reacted to national and international pressures on their activities from the mid 1990s to 2006. The article also analyzes what effects the changing surroundings of the Nordic alcohol monopolies have had on the monopolies' present tasks, positions and political aims. The method used in this study is document analysis and interviewing. The material analysed includes annual reports of the Nordic alcohol monopolies, their web pages, reports and brochures, and the laws and regulations pertaining to the monopolies. The article shows that the monopolies have worked purposefully to make themselves popular with the public, with an increased focus on customer service. These changes are based upon both international pressures and changes in perspective within politics in general, where a slow transition from a collectivist solidarity perspective to a more individualistic lifestyle perspective can be discerned.


2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
L Green

Abstract On March 29th 2019, the United Kingdom (UK) was due to exit the EU in a process known informally as ’Brexit’. This exit and entry into a 2-year transition is a period of unprecedented political and social upheaval - with many unknowns and much uncertainty attached to the outcomes and future impact. In preparation for Brexit, Public Health Wales commissioned the Wales HIA Support Unit to carry out a health impact assessment of Brexit in Wales to support and inform its and other public bodies planning and future work. This paper examines the unique HIA carried out between July and December 2018 on the impact of the UK withdrawal from the EU in Wales. It discusses the robust, participatory process undertaken, the stakeholders involved and the benefits reaped from this. It highlights the evidence gathered and analysed including the collection methods, the complex nature of the work and disseminates the main findings from the HIA including the potential determinants of health and population groups identified. Finally, it describes the challenges faced, how these were overcome, and the huge benefits, impact and influence it has had to date across a wide range of UK and Welsh organisations and public bodies. This work demonstrates continued leadership in the field of impact assessment and spearheads the requirement for public bodies to carry out HIAs as part of the forthcoming statutory requirements of the Public Health (Wales) Act 2017 an can inform practice at a global level. Key messages HIA can inform and influence action in response to important strategic decisions. The Brexit HIA is a unique example which can inform international HIA practice.


Author(s):  
V. O. Tyumentsev

The subject of this article is the competence of the European Union (EU) in the public health field within the territory of the Member States of this organization. The purpose of this article is to analyze how the EU's competence is distributed in relation to the competence of the member states using the primary treaty of the organization as a source. The article examines the powers of the EU organization within both the main and additional competence and analyzes how the EU interacts with the member states in the framework of health protection in accordance with the legal provisions of the primary source. The main and additional competence of the EU is considered separately, and there is also an analysis of the features and possible prospects of the legal regulation of health protection within the relevant branch of the law of the European Union.


2020 ◽  
Vol 2 ◽  
Author(s):  
Elspeth Guild

When Covid-19 was acknowledged to have arrived in Europe in February-March 2020, politicians and public health authorities scrabbled to find appropriate and effective responses to the challenges. The EU obligation contained in Article 9 Treaty on the Functioning of the European Union (TFEU) requiring the EU (including the Member States to achieve a common protection on human health, however, seems to have been missing from the responses.) Instead, borders and their control became a site of substantial political debate across Europe as a possible venue for effective measures to limit the spread of the pandemic. While the most invasive Covid-19 measures have been within EU states, lockdown, closure of businesses etc., the cross-border aspects (limitations on cross border movement) have been important. In the European Union this had important consequences for EU law on border controls, in particular free movement of persons and the absence of controls among Schengen states. It also implicated border controls with third countries, including European Free Trade Area (EFTA and Switzerland) all states neighboring the EU, the UK (having left the EU on 1 January 2020) the Western Balkans and Turkey. While EU law distinguishes between Schengen borders where no control takes place on persons, non-Schengen EU borders, where controls take place but are limited to identity checks and border controls with third countries and external borders with third countries (non-EFTA or Swiss) the responses of many Member States and the EU institutions abandoned many aspects of these distinctions. Indeed, the difference between border controls between states (inside Schengen, the EU, EFTA, or outside) and internal restrictions on movement became increasingly blurred. Two approaches—public health and public policy—were applied simultaneously and not always in ways which were mutually coherent, or in any way consistent with the Article 9 TFEU commitment. While the public health approach to movement of persons is based on ensuring identification of those in need of treatment or possibly carrying the disease, providing treatment as quickly as possible or quarantine, the public policy approach is based on refusing entry to persons who are a risk irrespective of what that may mean in terms of propagating the pandemic in neighboring states or states of origin. I will examine here the ways in which the two approaches were applied in the EU from the perspective of EU law on border controls.


2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  

Abstract The plenary will continue the debate on The future of Public Health in Europe introduced in the previous plenary, tackling the role of the EU and its institutions in ensuring that health is addressed in all EU policies. The EU is firmly committed to implementing the 2030 Agenda and the Sustainable Development Goals through its range of institutional mechanisms. Incoming Commission President von der Leyen has pledged to refocus the European Semester ‘to make sure we stay on track with our SDGs’. These developments, together with the broad recognition of the central role of health in the SDGs and the momentum given by the new EU policy cycle presents a unique window of opportunity to critically reappraise the role of health in the EC, which, at least, on paper makes for an ideal Health in All Policies institution. The first keynote by Director General Anne Bucher, DG SANTE, will draw on the ‘hot of the press’ results of the November 2019 State of Health in the EU exercise, including the EU Country Health Profiles and the Commission Staff Companion Report. She will highlight the main health and health system challenges faced by EU Member States—ranging from the burden posed by preventable mortality to the vaccination crisis and the resilience of the health workforce. Prof. Scott Greer’s keynote will contend that to tackle these challenges we need to go beyond Public Health Article 168 and its subsidiarity corset. He will speak to the need to proactively employ the much stronger (health) policy tools within the large body of EU law underlying the internal market and to draw on the EU’s newfound role in fiscal governance such as through the European semester. Prof. Greer will draw on the innovative results of the new edition of the seminal study ‘Everything you always wanted to know about European Union health policies but were afraid to ask’ which will be distributed to participants. The following panel will debate on the practical implementation and political economy questions arising from the plenary’s postulates. Prof. John Middleton, ASPHER’s president, will address the implications for the Public Health profession such as training in public health leadership, overhauling public health competencies or indeed the understanding of the public health profession itself. The second panellist will address the political economy implications of bringing health across EU policies and how to bypass the complexities of working across policy sectors in the EU institutions. The panel will actively interact with the participating audience through a range of innovative ways. Panellists Anne Bucher DG SANTE, European Commission Scott L. Greer Health Management and Policy, University of Michigan John Middleton The Association of Schools of Public Health (ASPHER)


2021 ◽  
pp. 1-28
Author(s):  
Adebambo Adewopo

Abstract The COVID-19 pandemic has continued to exert enormous pressure on public health policies and systems, with far-reaching implications. The race for vaccines has raised important intellectual property rights issues. These are evident in the need to advance the public interest and in the obligation of governments to address the challenge of access to vaccines, especially in sub-Saharan countries like Nigeria with relatively underdeveloped healthcare and innovation ecosystems. While the Nigerian Patents and Designs Act (PDA) establishes a compulsory licence regime that affords access to patented drugs, existing public healthcare is severely challenged in providing access to new medicines. This article examines the framework for patent protection of pharmaceuticals designed to meet public health challenges, such as those presented by the pandemic. It recommends the implementation of a government use provision under the PDA, with a view to addressing the challenge of access to COVID-19 vaccines.


Author(s):  
V. Casella ◽  
M. Franzini ◽  
M. T. Rocca ◽  
A. Pogliaghi ◽  
N. Fiscante ◽  
...  

Abstract. Exposomics is a science aiming at quantifying the effects on human health of all the factors influencing it, but genetic ones. They include environment, food, mobility habits and cultural factors. The percentage of the world’s population living in the urban areas is projected to increase in the next decades. Rising industrialization, urbanization and heterogeneity are leading to new challenges for public health and quality of life in the population. The prevalence of conditions such as asthma and cardiovascular diseases is increasing due to a change in lifestyle and air quality. This enlightens the necessity of targeted interventions to increase citizens’ quality of life and decrease their health risks. Within the EU H2020 PULSE project, a multi-technological system to assist the population in the prevention and treatment of asthma and type 2 diabetes has been developed. The system created in PULSE features several parts, such as a personal App for the citizens, a set of air quality sensors, a WebGIS and dashboards for the public health operators. Citizens are directly involved in an exchange paradigm in which they send their own data and receive feedbacks and suggestions about their health in return. The WebGIS is a very distinguishing element of the PULSE technology and the paper illustrates its main functionalities focusing on the distinguishing and innovative features developed.


Sign in / Sign up

Export Citation Format

Share Document