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Rare diseases: Europe’s challenges

Outline of the Community (European Union) legislation about Rare diseases: Europe’s challenges

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These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Public health > Threats to health

Rare diseases: Europe’s challenges

The Commission proposes a strategic approach to improving the recognition of rare diseases and patient access to suitable treatment. It supports cooperation between the European Union (EU) Member States and the development of a network of experts made up of health professionals.

Document or Iniciative

Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions of 11 November 2008 on Rare Diseases – Europe’s challenges [COM(2008) 679 final – Not published in the Official Journal].

Summary

Rare diseases, 80% being genetic in origin, are defined as those diseases which affect not more than 5 per 10 000 persons in Europe. The limited number of patients accounts for the current low level of medical knowledge and expertise, even though these diseases can lead to the death or disability of the people affected.

This communication presents a comprehensive Community strategy aimed at supporting the recognition, prevention, management and treatment of rare diseases. The Commission encourages Member States to share their knowledge and resources in this field. The Commission will be assisted by the European Union Advisory Committee on Rare Diseases (EUACRD).

Identification and visibility

The Commission is contributing to the development of the International Classification of Diseases (ICD) developed by the World Health Organisation (WHO) and to the classification and codification of rare diseases in the new version of this classification. The Commission also supports the development of an evolving European database aimed at professionals and patients.

Information networks and European Reference Networks for rare diseases are essential means for exchanging best practice and epidemiological expertise.

Screening, diagnosis and prevention

Member States should be able to use comparable data with regard to the screening and primary prevention of rare diseases. Early diagnosis of diseases can be made using biological tests. The design and validation of these tests can be facilitated through the establishment of European reference networks of expert diagnostic laboratories.

Access to care

Member States are undertaking concrete measures to ensure the quality of and universal access to care, in particular by establishing centres of expertise at national and regional levels. Their activity could be extended to providing social services in order to improve the quality of life of patients.

Access to medication

National authorities should proceed with a joint scientific assessment of orphan medicinal products. Member States should adapt their pricing and reimbursement systems on the basis of this assessment.

The Commission requests that the European Medicines Agency (EMA) encourage a common approach to improving access to compassionate use programmes. These programmes allow the provision of new medicines before they have been approved and/or reimbursed.

Regulations applicable to medical devices should be adapted to the market for orphan medicinal products. The Commission should also provide for incentive measures to encourage pharmaceutical companies to develop new treatments.

e-Health

Information and Communication Technologies (ICTs) contribute to facilitating the exchange of scientific data. The telemedicine systems and services can enable professionals to share their expertise and to gain specialist knowledge.

Scientific research is supported by the 7^th Framework Programme, which funds the development of computer assisted modelling, in particular, with the aim of increasing knowledge of the physiological and pathological processes of rare diseases.

RELATED ACTS

Proposal for a Council recommendation of 11 November 2008 on a European action in the field of rare diseases[COM(2008) 726 final – Not published in the Official Journal].

This Proposal is based on the conclusions of the communication of 11 November 2008 which promotes a European strategic approach to rare diseases. In this context, the Council invites Member States to:

establish strategies and national plans before 2013 in order to ensure universal access to and the high quality of care;
adopt a European definition of rare diseases so that they can be referenced and coded more easily in care and reimbursement systems;
identify research priorities and ongoing projects, with particular regard to basic, clinical and translational research and enable patients to benefit from new therapeutic advances;
encourage the development of national and regional centres of expertise, cross-border care and expert networks;
adopt common methods in terms of screening, treatment and monitoring therapeutic techniques;
support the activities of parent associations;
ensure the viability of research infrastructures at national and European levels.

The Commission is invited to inform the Council on the progress of actions undertaken by Member States as part of the comprehensive strategy on rare diseases.

Rare diseases

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Rare diseases

Outline of the Community (European Union) legislation about Rare diseases

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Public health > Threats to health

Rare diseases

Document or Iniciative

Council Recommendation 2009/C 151/02 of 8 June 2009 on an action in the field of rare diseases.

Summary

This Recommendation aims at introducing measures at European level to increase level of knowledge on rare diseases, as well as improve the quality of life and care of patients.

Plans and strategies

The European Commission recommends that Member States introduce plans or strategies to combat rare diseases. The aim is provide patients suffering from these diseases with high quality care, diagnosis, treatment and effective orphan drugs.

In this regard, Member States are encouraged to adopt a plan or strategy under their respective social and health schemes by 2013. These plans or strategies should integrate all current and future initiatives at local, regional and national levels in the field of rare diseases.

These national initiatives should form part of the framework of the European Project for Rare Diseases National Plans Development (EUROPLAN), which itself belongs to the Community action programme in the field of public health for 2008-2013.

Definitions, codification and inventorying

At present, a rare disease is defined as such if it does not affect more than 5 in 10 000 persons. The Commission considers this definition needs expanding and encourages Member States to work together on a definition which takes into account the parameters of incidence.

The Commission action aims to facilitate the coding and traceability of rare diseases in all health information systems, and particularly in the future version of the International Classification of Diseases (ICD). An inventory could be established on the basis of the Orphanet network or other networks.

Member States are called upon to support specific information networks, registers and databases relating to diseases.

Research

Current knowledge in research on rare diseases should be updated.

Needs and priorities should be determined in the field of basic, clinical, translational and social research before encouraging national researchers to participate in this kind of programme.

The European Commission is responsible for establishing cooperation with third countries and fostering the exchange of information and the sharing of expertise.

Centres of expertise and European Reference Networks

The Commission invites Member States to identify qualified centres of expertise by the end of 2013 and ensure that these centres benefit from support measures. These centres are to be encouraged to participate in European Reference Networks and to develop a multidisciplinary approach.

Healthcare pathways for patients suffering from a rare disease should be created through cooperation between experts and professionals in this field. Experts should be mobile in order to facilitate the treatment of patients in their own environment.

Information and communication technologies (ICTs) such as telemedicine should be integrated, ensuring distant access to specific healthcare.

Gathering expertise at European level

The Commission considers it crucial to gather different national experts in the field of rare diseases together in order to support:

the exchange of best practice in terms of diagnostic tools and medical care as well as education and social care;
teaching and training for healthcare professionals;
medical training in the diagnosis of diseases and aspects related to genetics, immunology, neurology, oncology or paediatrics;
guidelines on population screening;
exchange of information between Member States.

Empowerment of patient organisations

The creation and development of associations for patients suffering from rare diseases are encouraged insofar as this facilitates access for patients to up-to-date information.

Context

A first Community action programme on rare diseases covering the period 1999 to 2003 defined a rare disease as a disease affecting less than 5 in 10 000 persons. Its aim was to improve knowledge in this field. This Recommendation forms part of this perspective and aims to enhance cooperation and knowledge in order to improve cover and treatment for rare diseases.

Related Act

Commission Decision No (EC) 2009/872 of 30 November 2009 establishing a European Union Committee of Experts on Rare Diseases

This Decision establishes an EU committee of experts on rare diseases. The committee is tasked with:

implementing Community action programmes;
preparing Commission reports;
providing opinions and recommendations;
assisting the Commission in disseminating the measures taken at Community level, as well drawing up guidelines.

The Committee comprises 51 members and their alternates. The Committee shall be convened by the Commission and shall meet on its premises three times a year.

Urgent measures to be taken to combat doping in sport

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Urgent measures to be taken to combat doping in sport

Outline of the Community (European Union) legislation about Urgent measures to be taken to combat doping in sport

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These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Education training youth sport > Sport

Urgent measures to be taken to combat doping in sport

Document or Iniciative

European Parliament Resolution of 14 April 2005 on combating doping in sport [Not published in the Official Journal].

Summary

Concerned by the ever increasing problem of doping in sport (in particular the use of ever more dangerous substances, such as growth hormones or Erythropoietin), the European Parliament would emphasise first of all that the use of chemicals to enhance performance is totally at odds with the values of sport as a social, cultural and education activity.

In order to combat doping more effectively, the European Parliament calls on the Commission to:

ensure that the Union’s external borders are effectively policed and combat the trade in illegal substances;
implement an effective, joined-up policy in all related fields (public health, prevention, education and pharmaceutical research);
support a sustained information campaign in order to establish an effective prevention policy;
together with the Member States, step up its collaboration with the World Anti-Doping Agency, the Council of Europe and the World Health Organisation;
involve all those concerned with sport in the decision-making process in this area, in order to tackle this problem effectively and promote a clean image of sport;
encourage cooperation between the Member States in order to develop common, effective methods for monitoring and certifying the use of chemical substances and compounds in gymnasia and sports centres frequented by young people in particular;
propose, in the Seventh Research Framework Programme, further research into different methods of doping detection and control.

Doping: a reality to be tackled

Doping is a real public health problem today. As the 2004 Athens Olympics showed, it has become worryingly prevalent in all areas of sport and at all competitive and amateur levels. Not only does it place athletes in danger, but it falsifies competition results, damages the image of sport, especially for young people, and tarnishes its ethical dimension.

Related Acts

Parliament Resolution of 17 December 1998 on urgent measures to be taken against doping in sport [Official Journal C98 of 09.04.1999]

The EU Role in Global Health

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The EU Role in Global Health

Outline of the Community (European Union) legislation about The EU Role in Global Health

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Development > Sectoral development policies

The EU Role in Global Health

Document or Iniciative

Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions – The EU Role in Global Health [COM(2010) 128 final – Not published in the Official Journal].

Summary

The Commission presents principles to improve action undertaken by the European Union (EU) as regards protecting world health.

Health protection in non-Member States of the EU aims mainly at preventing health risks and reducing inequality of access to care. In addition, action in this area must take into account a number of social, economic and environmental factors.

Improving global governance

The Commission recommends better coordination of the different action undertaken by States or groups of States, at:

global level, in order to defend a single position within the World Health Organization (WHO) and the United Nations (UN);
regional level, to develop exchange and networks between neighbouring States;
national level, to support public policies and the control of public funding, as well as interaction with other areas (such as education, youth empowerment, the family, etc.).

Developing universal health coverage

Universal coverage of health services should be established in the poorest countries. In this regard, the EU should increase its public development aid (PDA), but also reinforce its effectiveness and predictability. The Commission also recommends:

concentrating aid to serve the most fragile populations and countries;
strengthening the effectiveness and equity of health systems, as well as their functioning in terms of workforce, access to medicines, infrastructure, logistics and decentralised management;
having recourse to global initiatives and existing international financial institutions, but also to innovative funding.

Increasing policy coherence

Key issues in health policy should be taken into account in other areas, such as:

trade, in particular with regard to intellectual property rights, access to essential medicines, opening up generic medicine competition and combating counterfeiting;
managing migration, which should not undermine the availability of health professionals in developing countries;
defence and security, in order to better address fragile contexts and to provide an early response to international health risks;
food safety, food aid and nutrition, through public policies and the monitoring of nutritional status in the population;
climate change – the objective of health protection should be taken into account when allocating new funding.

Particular attention should also be paid to the fields of education and youth.

Research and innovation

Access to health services, medical technologies and medicines should benefit all. Research and innovation strategies should therefore be directed towards:

strengthening the research process overall – innovation, implementation, access, monitoring and evaluation;
collecting comparable data and statistics at global level, by collaborating with national and international organisations working on world health (WHO, OECD, etc.);
improving the dissemination of factual information, including risks, and the safety of food, feed, pharmaceuticals and medical devices.

Optimising skills

The EU must put in place mechanisms to optimise:

European action in EU countries and external countries, particularly within a platform to exchange information and through the development of common positions between EU countries and the Commission;
monitoring of European aid and implementation of the EU Code of Conduct on Division of Labour in the area of health;
dialogue between the key global players, in partnership with UN agencies and international financial institutions.

Context

The adoption of the Millennium Development Goals (MDGs) in 2000 has led to progress being made with regard to reducing global poverty. However, progress in developing countries is still uneven and often insufficient.

The international community has therefore enhanced its efforts regarding the three MDGs relating to health (reducing child mortality, improving maternal health, and combating disease – in particular HIV/AIDS and malaria).

Alzheimer’s and other dementias: European initiative

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Alzheimer’s and other dementias: European initiative

Outline of the Community (European Union) legislation about Alzheimer’s and other dementias: European initiative

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Public health > Health determinants: lifestyle

Alzheimer’s and other dementias: European initiative

Document or Iniciative

Communication from the Commission to the European Parliament and the Council of 22 July 2009 on a European initiative on Alzheimer’s disease and other dementias [COM(2009) 380 final – Not published in the Official Journal].

Summary

This Communication lays down milestones for a European initiative on Alzheimer’s disease and other forms of dementia.

Definitions

Dementia is a neurodegenerative disease which affects mental ability such as memory, thinking and judgement, even causing a deterioration in personality.

The most common types of dementia are:

Alzheimer’s disease (50 to 70 % of cases);
dementia caused by successive strokes (30 % of cases);
Frontotemporal dementia;
Pick’s disease
Binswanger’s disease;
Lewy-Body dementia.

Obstacles

Obstacles hindering the introduction of a European initiative to combat forms of dementia involve:

the lack of prevention and early diagnosis of the disease;
the lack of epidemiological data which limits understanding of the mechanisms of the disease;
the lack of exchanges of good practices between Member States;
the image and negative impact of the disease on the population.

First objective: prevention and early diagnosis of the disease

Preventing the disease or making an early diagnosis can delay the development of the disease. However, these risk factors are not the same according to the different forms of dementia. It is, for example, easier to detect vascular dementia than Alzheimer’s disease since risk factors for vascular dementia are already well known:

high blood pressure;
high cholesterol levels;
smoking.

Member States already have avenues to explore regarding the development of effective prevention of the disease. In particular:

the promotion and stimulation of physical and mental activities throughout life;
the control of the vascular risk factors mentioned above.

In order to meet this objective of prevention and early diagnosis, Member States shall put in place the following actions:

promote cardiovascular health and physical activity;
produce recommendations to inform the public;
include older people in a flexible retirement regime to allow them to remain active.

Second objective: to improve epidemiological knowledge

The European Commission proposes to collect data on the impact of these diseases through the “European Collaboration on Dementia (EuroCoDe)” project. The framework of the “Health” programme may also be used to prepare new criteria for early diagnosis. The Seventh Framework Programme for research and technological development (FP7) may also offer an effective research framework for Alzheimer’s disease and other forms of dementia.

It is also necessary to harmonise existing research frameworks both at European and national level in order to prepare coherent policies. To this end, actions include:

using the European Health Examination Survey to provide new Europe-wide data on the prevalence of people with early cognitive deficiencies;
launching a pilot Joint Programming approach to combat neurodegenerative diseases.

Third objective: exchange of good practices

Exchange of good practices may take place through the Open Method of Coordination (OMC) for social protection, social inclusion and long-term care. Moreover, the Commission may provide information on how ongoing Community programmes can finance these exchanges.

The OMC can help to define quality frameworks for medical and care services for people affected by the disease.

The European Union Disability Action Plan 2003-2010 (DAP) can also be used to support patients’ organisations.

Fourth objective: to respect patients’ rights

The Commission intends to establish a European Network for the protection of the rights and dignity of people with dementia. This Network would be responsible for working on issues related to the dignity, autonomy and social inclusion of patients.

Context

7.3 million Europeans between 30 and 99 years of age were suffering from dementia in 2006. According to the “Dementia in Europe Yearbook” report (2008) , the total direct and informal care costs of the disease amounted to EUR 130 billion for the European Union in 2005. Coordinated action at European level would reduce these figures and combat this major health problem.

Multi-annual programme of action for health

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Multi-annual programme of action for health

Outline of the Community (European Union) legislation about Multi-annual programme of action for health

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Public health > European health strategy

Multi-annual programme of action for health (2014-2020) (Proposal)

Proposal

Proposal for a Regulation of the European Parliament and of the Council of 9 November 2011 on establishing a Health for Growth Programme, the third multi-annual programme of EU action in the field of health for the period 2014-2020 [COM(2011) 709 final – Not published in the Official Journal].

Summary

The Health for Growth Programme (2014-2020) is the third multi-annual programme of European Union (EU) action. It helps/supports Member States in order to:

undertake the necessary reforms to achieve innovative and sustainable health systems;
improve access to better and safer health care for citizens;
promote good health of European citizens and prevent diseases;
protect European citizens from cross-border threats.

Objective No 1: Contributing to innovative and sustainable health systems

The European Commission must help Member States to address shortages of human and financial resources. It must also promote the implementation of innovation in health care, for example e-Health, and the sharing of expertise in this field. The Programme also supports the European Innovation Partnership on Active and Healthy Ageing.

Objective No 2: Increasing access to better and safer healthcare for citizens

The Commission suggests setting up the accreditation of European Reference Networks. This would allow, for example, action to be supported in the field of rare diseases. European guidelines should also be developed on patient safety and the use of antimicrobials.

Objective No 3: Promoting good health and preventing diseases

Member States are invited to exchange best practices on smoking prevention, abuse of alcohol and obesity. Specific action should also help to prevent chronic diseases, including cancer.

Objective No 4: Protecting citizens from cross border health threats

The Commission considers that the level of preparedness and response for serious cross border health threats must be improved.

Financial provisions

The financial allocation for the Programme is EUR 446 million for the period from 1 January 2014 to 31 December 2020. The following may participate in the Programme:

all EU Member States;
countries acceding to the EU, candidate countries and potential candidates benefiting from a pre-accession strategy;
European Free Trade Association (EFTA) countries in accordance with the conditions established in the European Economic Area (EEA) Agreement;
neighbouring countries and countries to which the European Neighbourhood Policy (ENP) applies in accordance with the conditions established in bilateral or multilateral agreements.

The EU may also make financial contributions in the form of grants or public procurement to fund actions having European added value, or grants for the functioning of non-governmental bodies. Such grants contribute 60 % of eligible costs and cover a wide spectrum of legally established organisations such as:

public authorities and public sector bodies;
research institutions;
health institutions;
universities;
higher education establishments;
undertakings.

In exceptional cases only, these grants may be up to 80 % of eligible costs.

Funding may also cover expenditure on preparatory, monitoring, control, audit and evaluation activities required for the implementation of the Programme.

Implementation of the Programme

Implementation of Programme actions shall be monitored by the Commission, in close collaboration with Member States. The Commission shall, furthermore, be assisted by a committee pursuant to the Regulation on the Commission’s exercise of implementing powers.

Member States shall designate National Focal Points in order to disseminate the Programme and its results in their countries.

This Regulation repeals the Decision on the Second programme of Community action in the field of health from 1 January 2014.

Reference

Proposal	Official Journal	Procedure
COM(2011) 709 final	–	2011/0339/COD