Category Archives: Public health

Being in good health is one of the main concerns of European citizens. The European Union (EU) is therefore striving to attain a higher level of health protection through all European policies and activities, in accordance with Article 168 of the Treaty on the Functioning of the European Union (TFEU). In particular, EU policy on health matters aims to improve public health, prevent diseases and threats to health (including those related to the lifestyles of European citizens), and combat major health scourges by promoting research. Community action complements national policies, and the Union encourages cooperation between Member States in the field of health.
However, defining national health policies remains an exclusive competence belonging to Member States. Consequently, EU action shall not include the definition of health policies, nor the organisation and provision of health services and medical care.
European health policy therefore consists of developing a shared competence with Member States and complementing national policies. The EU and Member States may also cooperate with third countries and competent international organisations.

European health strategy
Programmes and initiatives
Threats to health
Communicable diseases, Blood and human tissue, Antimicrobial agents
Health determinants: lifestyle
Tobacco, Alcohol, Nutrition and physical activity, Mental health
Health determinants: environment
Socio-economic health determinants, Environment, Electromagnetic fields, Genetics and screening

Seasonal influenza vaccination

Seasonal influenza vaccination

Outline of the Community (European Union) legislation about Seasonal influenza vaccination

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

Seasonal influenza vaccination

Document or Iniciative

Council Recommendation 2009/1019/EU of 22 December 2009 on seasonal influenza vaccination.

Summary

This Recommendation encourages Member States to take health measures to combat seasonal influenza.

Challenges

Influenza is contagious respiratory infection of viral origin, which occurs as epidemic in winter months. It can cause serious complications, even death.

For slight seasonal influenza, the number of deaths is estimated on average 8 in 100 000 population. This figure can rise to 44 during more severe years.

In the event of influenza epidemics, hospitals and medical services may become overburdened which leads to an increase in direct costs (resulting from the use of medical and non-medical resources) and indirect costs (due to productivity loss and absenteeism from work).

Vaccine Efficacy and Effectiveness

Seasonal influenza can be reduced through vaccinations. It is necessary that ‘risk’ groups in the population be vaccinated against influenza. Moreover, logistic aspects such as delivery and administration of vaccines represent major elements not to be underestimated in order to provide effective vaccine coverage.

It is important to act at Community level in order to avoid a new strain of the influenza virus becoming a pandemic, as took place throughout the 20th century in 1918, 1957 and 1968.

National plans and strategies

The aim of this Recommendation is that Member States adopt a national plan or strategy with regard to vaccine coverage. This plan should offset the current shortcomings that have been observed at this level.

The plan aims at covering 75% of the ‘risk’ population between now and the winter of 2014-2015. This group is defined in the guidelines published by the European Centre for Disease Prevention and Control (ECDC).

Member States are encouraged to submit reports to the Commission, on a voluntary basis, on the implementation of this Recommendation and specifically on the vaccination cover achieved within risk groups.

Information campaigns directed at healthcare professionals and persons belonging to the risk groups and their families should be carried out.

The Commission is invited to report to the Council regularly on the implementation of this Recommendation, based on the information received from Member States.

Context

In 2003, the World Health Organization (WHO) proposed vaccine coverage targets for the elderly of at least 50% in 2006 and 75 % in 2010. This Proposal suggests meeting the targets recommended by the WHO through a national plan or strategy.

Quality standards for human tissues and cells

Quality standards for human tissues and cells

Outline of the Community (European Union) legislation about Quality standards for human tissues and cells

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

Quality standards for human tissues and cells

Document or Iniciative

Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells [See amending act(s)].

Summary

Article 152 of the EC Treaty (henceforth Article 168 TFEU), requires the European Union to establish high quality and safety standards for the use of blood, organs and other substances of human origin.

In 1998, the European Group on Ethics in Sciences and New Technologies (EGE) confirmed the urgency of monitoring the conditions under which human cells and tissues circulate, the donation of which, anonymous and free, should remain basically a voluntary act. Moreover, the growing use of human tissues * and cells * in therapeutic treatment (reconstructive surgery, cancer and diabetes treatment) and the development of intra-Community trade in these substances make it necessary to define a minimum regulatory basis.

Tissues are groups of cells, which may be transplanted or implanted as viable cells, or otherwise preserved, fixed or altered. Originating from a live or dead donor *, they include: bone and musculo-skeletal elements (e.g. cartilage, tendons), cardiovascular tissues (e.g. arteries, veins, and heart valves), ocular tissue (e.g. cornea), nerve and brain cells, skin, foetal tissue, reproductive cells (e.g. semen, sperm, and ova) and stem cells.

SCOPE AND IMPLEMENTATION

This directive applies to the donation, procurement, testing, preservation, storage * and distribution * of human tissues and cells intended for human use. It also relates to manufactured products derived from human tissues and cells intended for human use. In the case of products made industrially from tissues and cells, the directive applies merely to donation, procurement and testing.

Blood and blood constituents, organs, tissues and cells used as an autologous graft * within the same surgical procedure and autologous cells for the manufacture of pharmaceuticals are excluded from the scope.

Member States must designate the competent authorities responsible for implementing the directive. They must keep the option of maintaining or introducing more stringent protective measures.

OBLIGATIONS ON MEMBER STATES’ AUTHORITIES

Supervision of human tissue and cell procurement

Member States must ensure that tissue and cell procurement and testing are carried out by persons with appropriate training and experience and that they take place in conditions approved by the competent authorities.

Accreditation, designation or authorisation of tissue establishments

All tissue establishments * must be accredited, designated or authorised by a competent authority, which may suspend or revoke such accreditation, designation or authorisation if, following inspections, it is shown that the establishment does not meet the requirements of the directive.

Inspection and control measures

The competent authorities must organise inspections and checks at tissue establishments at least every two years. The Member States, at the request of the Commission or another Member State, must provide information with information on the results of these inspections and checks.

Traceability

Member States must ensure traceability from the donor to the recipient and vice versa, of all tissues and cells procured, processed, stored or distributed on their territory. The traceability requirement also applies to all products and materials coming into contact with tissues and cells. To this end Member States shall ensure the implementation of a donor identification system which assigns a unique code to each donation and to each of the products associated with it. All tissues and cells must be identified with a label that contains information on the procedures for procurement and receipt, processing, storage and distribution.

The data necessary to ensure traceability must be kept for at least thirty years after clinical use.

Import/export of human tissues and cells

Member States must ensure that all imports and exports of human tissues and cells from and to third countries comply with the directive’s quality and safety requirements and are undertaken by accredited, designated and authorised tissue establishments so as to ensure the traceability of tissues and cells.

Register of tissue establishments and reporting obligations

The competent authorities must maintain a publicly accessible register of tissue establishments specifying the activities for which they have been accredited, designated or authorised. For their part, tissue establishments must keep a record of their activities and submit an annual report, which is also publicly accessible, to the competent authorities.

Notification of serious adverse events and reactions

Member States must provide for the creation of a system for the notification, registration and transmission of information on any incident linked to the procurement, testing, processing, storage, distribution and transplantation of tissues and cells.

DONOR SELECTION AND EVALUATION

Principles governing tissue and cell donation

Member States must encourage voluntary and unpaid donations of tissues and cells. However, donors may receive compensation strictly limited to making good the expenses and inconveniences related to the donation (e.g. travel expenses). No promotion and publicity activities are allowed in support of the donation of human tissues and cells with a view to offering or seeking financial gain or comparable advantage. The general rule is that Member States must endeavour to ensure that the procurement of tissues and cells is carried out on a non-profit basis.

Consent

The consent of donors, recipients or their next of kin is obligatory. They must receive information on the purpose and nature of the procurement, the associated risks, the analytical examinations, the recording and protection of donor details and medical confidentiality. In the case of a dead donor, all this information must be provided to the next of kin and all the necessary authorisations and consent must be obtained from the next of kin before any operation takes place.

Data confidentiality

Member States must take all necessary measures to ensure that all data collected and to which third parties have access are rendered anonymous. The recipient’s identity must never be divulged to the donor or his or her family, or vice versa. To this end, measures must be adopted to ensure data security and prevent unauthorised modifications to files and records.

Selection, evaluation and procurement

Donors must be evaluated and selected in accordance with strict standards, depending on the nature of the donor (dead or alive, specific case of children) and the type of operation.

QUALITY AND SAFETY OF TISSUES AND CELLS

Quality management

Each tissue centre must put in place a quality control system, which must include at least the following information: guidelines; operating procedures; training and reference manuals; donor records (to be kept for at least 30 years); information on the final destination of tissues or cells. These documents must be available for official inspections by agents of the competent authority.

Tissue and cell reception

Tissue and cell donations must be subjected to tests relating to specific requirements. The same applies in respect of selection, acceptance and packaging of tissues and cells.

Tissue and cell processing

Tissue establishments must include in their operating procedures all the processes that affect quality and safety. They must ensure that the equipment used, the working environment and process monitoring conditions comply with the requirements regarding the processing, storage and distribution of tissues and cells.

Tissue and cell storage conditions

Storage conditions must comply with specific requirements. Storage processes must be carried out under controlled conditions.

EXCHANGE OF INFORMATION, REPORTS AND PENALTIES

Member States must create a system for identifying human tissues and cells in order to ensure their traceability. With their collaboration, the Commission must devise a single European codification system in order to provide information on the main features and properties of the tissues and cells.

Member States must send the Commission, three years after the implementation date for this directive and every three years thereafter, a report on the activities undertaken, with reference to the provisions of this directive, and including an account of the inspection and monitoring measures taken.

Member States must lay down the rules on penalties applicable to infringements of the national provisions and notify those penalties to the Commission by the date when this directive enters into force at the latest.

Ethical considerations remain the responsibility of the Member States

In the course of the adoption process for the directive, many MEPs, concerned by the ethical aspects of the subject, advocated the inclusion of minimum requirements covering, in particular, a ban on human cloning and a guarantee that no abortions could take place with a view to obtaining foetal tissue. The outcome was that ethical considerations did not come under the scope of the directive and would therefore be left to the appreciation of the Member States. On the subject of cloning, the directive does not interfere with decisions made by Member States concerning the use or non-use of any specific type of human cells, including germ cells and embryonic stem cells.

Key terms used in the act
  • cells: individual human cells or a collection of human cells when not bound by any form of connective tissue;
  • tissue: all constituent parts of the human body formed by cells;
  • donor: every human source, whether living or deceased, of human cells or tissues;
  • storage: maintaining the product under appropriate controlled conditions until distribution;
  • distribution: transportation and delivery of tissues or cells intended for human applications;
  • tissue establishment: a tissue bank or a unit of a hospital or another body where activities of processing, preservation, storage or distribution of human tissues and cells are undertaken. It may also be responsible for procurement or testing of tissues and cells;
  • autologous use: cells or tissues removed from and applied in the same person.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 2004/23/EC

7.4.2004

7.4.2006

OJ L 102 of 7.4.2004

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 596/2009

7.8.2009

OJ L 188 of 18.7.2009

Related Acts

Implementing measures

Commission Decision 2010/453/EU of 3 August 2010 establishing guidelines concerning the conditions of inspections and control measures, and on the training and qualification of officials, in the field of human tissues and cells provided for in Directive 2004/23/EC of the European Parliament and of the Council [notified under document C(2010) 5278] Text with EEA relevance

This Decision establishes guidelines concerning the implementation of inspection and control measures in the field of human tissues and cells. It defines the responsibilities and the qualificatoin and training requirements of inspectors. However, they are not legally binding.

Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells [Official Journal L 38 of 9.2.2006].
This implementing directive establishes specific technical requirements for each step in the human tissue and cell preparation process, in particular:

  • Requirements for the procurement of human tissues and cells;
  • Selection criteria for donors of tissues and cells;
  • Laboratory tests required for donors;
  • Tissue and/or cell donation and procurement procedures and reception at the tissue establishment;
  • Requirements for direct distribution to the recipient of specific tissues and cells.

Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (Text with EEA relevance)

This Directive applies to the coding, processing, preservation, storage and distribution of human tissues and cells, and products derived from human tissues and cells.

Implementation reports

Communication from the Commission of 6 January 2010 to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on the application of Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells [COM(2009) 708 final – Not published in the Official Journal].

This Communication states that the implementation of Directive 2004/23/EC by Member States is satisfactory. Member States have now appointed their competent authorities. They have also put in place an accreditation, designation, authorisation and licensing system of tissue establishments, as well as systems for reporting, investigating, registering and transmitting information about serious adverse events and reactions, and testing requirements.
However, Member States must still put in place specific systems for authorising the tissue and cell preparation processes, as well as the process of accreditation, designation, authorisation and licensing of different establishments. They must also improve the inspection and monitoring of imports and exports of tissues and cells.

Organ donation and transplantation in the European Union

Organ donation and transplantation in the European Union

Outline of the Community (European Union) legislation about Organ donation and transplantation in the European Union

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

Organ donation and transplantation in the European Union

Organ transplantation remains essential for the treatment of certain diseases. However, several factors must be taken into consideration where this therapeutic method is concerned: the risk of transmission of disease, the limited supply of organs and organ trafficking. This communication therefore aims to present the various potential options to ensure the quality and safety of organs, increase their availability and combat organ trafficking.

Document or Iniciative

Communication from the Commission to the Council and the European Parliament of 30 May 2007 entitled “Organ donation and transplantation: Policy actions at EU level” [COM(2007) 275 final – Not published in the Official Journal].

Summary

During the past decades, organ transplantation has increased and become widespread. It is a form of treatment that is indispensable for certain diseases, and the results in terms of life years gained and improvement in quality of life are often positive.

Nonetheless, organ donation and transplantation are sensitive topics, dealt with differently throughout the EU in accordance with the cultural values and legal, administrative and organisational issues of each Member State.

Moreover, these topics present three major obstacles that the Commission intends to deal with. These are the risk of transmission of disease, the limited supply of organs and organ trafficking.

The Commission therefore plans measures to improve the quality and safety of organs, increase their availability in the EU and combat organ trafficking.

Improving quality and safety

HIV, hepatitis B and C, bacteria, fungi, parasites and various types of cancer can be transmitted when an organ is transplanted. The transmission of disease by a donor organ can result in the death of the recipient.

It is therefore essential that measures be introduced into every stage of the transplant process in order to improve the quality and safety of organs. A risk-benefit analysis must be carried out so that the organs can be allocated to suitable recipients.

This entails defining the risks to which the recipient is exposed in view of his/her characteristics and the profile of the donor, and determining the consequences of not performing transplantation. Following this analysis, a rational decision will be taken concerning the transplantation.

There is also a need for effective transportation of organs to avoid their deterioration. While maintaining medical confidentiality, the organ container must be labelled and contain the necessary documentation.

It is important to ensure traceability from the donor to the recipient. Any transplantation system must also be able to highlight unexpected complications and detect serious or unexpected adverse events.

Given that an organ donor is often also a tissue donor, the quality and safety requirements for organs will be associated with the existing community system for tissues and cells.

It is essential to set up systems for the authorisation of establishments and programmes of organ donation based on common quality and safety criteria.

However, the legislation concerning quality and safety differs from one Member State to another. A high level of protection for patients must therefore be ensured throughout the EU.

Increasing the availability of organs

The Member States are facing a serious shortage of organ donors on the one hand and an increase in the demand for organs on the other.

Rates of donors differ from one Member State to another. These differences may stem from cultural, social and historical factors in each country, and the organisational characteristics of the donation system and certain aspects of their health service.

Furthermore, families are not always made aware of the possibility of making a donation, and many potential donors are lost because they are not registered as such. The establishment of an effective system making it possible to find people who can become donors after their death thus remains essential to increase the rate of donations. This system must ensure that the organs of people who wish to become donors will really be available.

Training and employing health professionals involved in organising the donation process and identifying people who could become donors after their death has resulted in an increase in organ donations in several Member States.

Another method of increasing the number of donors is to encourage donations from living donors. These have increased in recent years, particularly because the risk to donors is low and the results of the transplants have been positive.

Donors who are not ideal because of disease and a history of malignancy (“marginal donors”) can also be taken into consideration under certain circumstances.

Raising public awareness also has a role to play in increasing donations. Society still does not take a positive view of organ donations, and some families refuse to donate the organs of deceased relatives. However, messages can influence individuals’ decisions. Effective communication therefore needs to be established. The help of communication experts is important here, and the media and health professionals need to have a better knowledge of transplantation issues.

Another way of raising public awareness is the use of a European donor card stating whether the holder wishes to donate his/her organs or not.

Fighting organ trafficking

Criminal organisations have recognised the lucrative opportunity presented by the gap between the supply of and demand for organs. As a consequence, such organisations may induce poor people to sell their organs.

Several international and Community legal instruments condemn and outlaw organ trafficking, such as the European Charter on Fundamental Rights and the Oviedo Treaty on Human Rights and Biomedicine and its Additional Protocol on the Transplantation of Organs and Tissues of Human Origin.

The Commission makes frequent reference to these instruments.

Follow-up actions

The Commission aims to make transplantation systems more efficient and more accessible. It is therefore necessary to identify the most efficient systems at EU level, promote best practice and help countries with less-developed systems to improve these.

It will also encourage the Member States to work together on establishing efficient systems aimed at identifying individuals who can become donors after their death, promoting training for professionals, encouraging donations from living donors and evaluating the use of organs from “marginal donors”.

The Commission proposes two mechanisms for action: an action plan on strengthened cooperation between Member States and a legal instrument on quality and safety of organ donation and transplantation.

The action plan will enable countries to increase organ donations and to provide fair access to transplantation, as well as exchanging expertise to improve organisational aspects.

As far as the legal instrument is concerned, a European directive setting standards of quality and safety for organs could be adopted. This instrument could, among other things, include quality and safety standards for the authorisation of establishments and programmes of organ donation, ensure a complete characterisation of the organ and establish authorisation structures.

Related Acts

Proposal for a Directive of the European Parliament and of the Council on standards of quality and safety of human organs intended for transplantation [ – Not published in the Official Journal].

This Proposal for a Directive on standards of quality and safety of human organs intended for transplantation lays down rules aiming to ensure high standards of quality and safety for organs intended for transplantation into the human body.

It applies to the:

  • donation;
  • procurement;
  • testing;
  • characterisation;
  • preservation;
  • transport;
  • and transplantation of organs.

To achieve that objective, the Proposal plans to rely on national quality programmes which ensure the traceability of organs at each stage in the chain from donation to transplantation or disposal.

Member States shall ensure that procurement of organs takes place in specialised procurement organisations and facilities. All organs must be characterised before transplantation.

Member States shall also attend to the conditions of transport of organs, ensuring traceability from donor to recipient. Their responsibility shall also extend to the personnel and the systems for the reporting of serious adverse effects and reactions.

It is also reiterated that organ donation must be voluntary and unpaid. Member States must provide donors with all the information necessary while guaranteeing their right to anonymity.

Member States shall designate the relevant competent authorities. The latter shall be responsible in particular for controlling the procurement organisations or transplantation centres and for supervising the exchanges of organs with other countries.

Codecision procedure ()

Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells [Official Journal L 102, 07.04.2004].

Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC [Official Journal L 33, 08.02.2003].

Threats to health

Threats to health

Outline of the Community (European Union) legislation about Threats to health

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

Threats to health

European Union action aims to prevent and combat the risks affecting the health of European citizens. It includes protective measures for the different fields of health security and monitoring. Similar to HIV, infectious diseases are on the increase. The control, prevention and monitoring of communicable diseases and pandemics are therefore among the priority objectives. Taking account of the extent to which blood, blood components, as well as human cells, tissues and organs are used medicinally; another aim is to increase their quality and security levels.
The Union also ensures the protection of citizens against the dangers related to certain medical treatments.

COMMUNICABLE DISEASES

General measures

  • Seasonal influenza vaccination
  • Preparing for an influenza pandemic and other health threats
  • European Centre for Disease Prevention and Control
  • Network for the surveillance and control of communicable diseases
  • Early warning and response system for the prevention and control of communicable diseases
  • The fight against bioterrorism (communication)

HIV/ AIDS

  • Combating HIV/AIDS in the European Union and neighbouring countries (2009-2013)
  • Action on HIV/AIDS in the European Union and neighbouring countries 2006 – 2009
  • Preventing HIV/AIDS (Council conclusions of 2005)

BLOOD AND HUMAN ORGANS AND TISSUE

Blood

  • Quality and safety standards for human blood and blood components
  • Suitability of blood donors

Tissue

  • Quality standards for human tissues and cells

Organs

  • Standards of quality and safety of organs intended for transplantation
  • Action plan on Organ Donation and Transplantation
  • Organ donation and transplantation in the European Union

ANTIMICROBIAL AGENTS

  • Résistance aux antimicrobiens : plan d’action
    (FR)
  • Antibiotic resistance
  • Community strategy against antimicrobial resistance
  • Prudent use of antimicrobial agents in human medicine

OTHER MEASURES

  • Rare diseases
  • Patient safety and the prevention of healthcare associated infections
  • Rare diseases: Europe’s challenges
  • Informing the general public in the event of a radiological emergency
  • Early exchange of information in the event of a radiological emergency
  • Radiological protection for persons undergoing medical examination or treatment
  • BSE: state of play in March 2003

Rare diseases: Europe’s challenges

Rare diseases: Europe’s challenges

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

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: 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 7th 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.

Action plan on Organ Donation and Transplantation

Action plan on Organ Donation and Transplantation

Outline of the Community (European Union) legislation about Action plan on Organ Donation and Transplantation

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

Action plan on Organ Donation and Transplantation

Document or Iniciative

Communication from the Commission of 8 December 2008 – Action plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States [COM(2008) 819 – Not published in the Official Journal].

Summary

The European Commission is presenting an Action Plan with the aim of strengthening cooperation between Member States in terms of organ donation and transplantation. This plan is also accompanied by a Proposal for a Directive on standards of quality and safety of human organs intended for transplantation.

This Action Plan lays down ten priority actions grouped under three challenges:

  • increasing organ availability;
  • enhancing the efficiency and accessibility of transplantation systems;
  • improving quality and safety.

Priority Actions for increasing organ availability

It is essential to increase the number of organ donors. To this end, the Plan advocates the appointing of transplant donor coordinators in all hospitals practising organ donation.

Hospitals must also promote Quality Improvement Programmes for organ donation, through a specific methodology. Existing methods are to be compared and those giving most results will be promoted.

Exchange of good practice is also strongly encouraged in the field of organ donation from living donors (concerning deceased donors, it is recommended that the potential of donations be maximised). In this regard, altruistic donation programmes should be set up, whilst storing personal data on donors in line with Directive 95/46/EC.

Good communication within families can have positive consequences on willingness to donate organs by family members. This is why health professionals and patient support groups are to strengthen communication and organise training in this field with families in order to increase organ donation potential.

Mobility of patients and donors should also be prioritised as part of cooperation between Member States. It should be possible to identify all donors in the Union. Tools are to be made available by the Commission to this end.

Priority Actions for enhancing the efficiency and accessibility of transplantation systems

Each Member State should prepare a national programme of priority actions to enhance the efficiency of transplantation systems. In particular, a series of common indicators shall be established to monitor organ donation policy.

The Action Plan strongly supports the drawing up of Community agreements on various aspects of transplant medicine. Cooperation is the best framework to generate joint solutions and monitoring mechanisms.

The Action Plan also invites Member States to establish Community agreements on the monitoring of the extent of organ trafficking in Europe. This trafficking is indeed a scourge in that it is one of the causes of the lack of available organs.

Member States are also invited to introduce a system or structure for the exchange of organs in particular for urgent cases and difficult to treat patients (such as children or patients requiring specific treatment).

Priority actions for improving quality and safety

Information concerning organ donations and transplantation should be compiled in registers to facilitate the evaluation of post-transplantation results. This information will be used in particular to develop good medical practices and to prepare a method to compare performance for the monitoring of organ recipients.

An accreditation system for organ donation, procurement and transplantation programmes should be established as part of a common methodology.

Context

As the Communication Organ donation and transplantation: Policy actions at European Union level had already pointed out, demand for organs outweighs supply all over the European territory. There are currently more than 56 000 patients waiting for an organ from a suitable donor. These shortages generate organ trafficking which is a violation of human dignity and fundamental rights. It is for this reason that Member States should strengthen cooperation in order to preserve organ quality and safety.

Related Acts

Proposal for a Directive of the European Parliament and of the Council of 8 December 2008 on standards of quality and safety of human organs intended for transplantation [ – Not published in the Official Journal].

This Proposal for a Directive on quality and safety standards for human organs intended for transplantation establishes a legal framework in this field.

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Standards of quality and safety of organs intended for transplantation

Standards of quality and safety of organs intended for transplantation

Outline of the Community (European Union) legislation about Standards of quality and safety of organs intended for transplantation

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

Standards of quality and safety of organs intended for transplantation

Document or Iniciative

Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation.

Summary

This Directive sets out a common framework on quality and safety standards for organs * of human origin intended for transplantation into the human body. It also aims to protect donors * and optimise exchanges between Member States and third countries.

Scope

This Directive covers only those organs to be transplanted into the human body, and not the use of organs for the purposes of research.

It applies to:

  • donation *;
  • procurement *;
  • testing;
  • characterisation *;
  • transport;
  • transplantation of organs.

It does not apply to:

  • blood;
  • blood components;
  • human tissues and cells;
  • organs, tissues and cells of animal origin.

Quality and safety of organs

Member States shall implement a quality and safety framework which defines the parameters of all stages of the chain from donation to transplantation *.

These quality and safety frameworks are to fix all of the parameters of the process continuously, from donation to transplantation. They have the following functions in particular:

  • to define traceability * procedures from donation to transplantation or disposal of the organ;
  • to implement standard operating procedures *;
  • to establish the qualifications of personnel.

The procurement of an organ (that has previously been subject to a characterisation) is to be performed in dedicated facilities and under the supervision of a medical doctor as defined in Directive 2005/36/EC.

All procured organs must be characterised before transplantation. The minimum information required includes:

  • le type of donor;
  • the blood group;
  • the cause and date of death of the donor;
  • the clinical history of the donor, including aspects such as neoplasia, hepatisis, HIV or IV drug abuse.

Other complimentary information may be requested, such as the medical history of the donor or, for example, physical and clinical data.

The transport of organs shall be carried out according to clearly defined criteria. The shipping containers used by organisations or companies must contain information such as contact details for the procurement and transplantation organisations, be marked ‘handle with care’ and contain safety instructions and method of cooling.

All organs procured, allocated and transplanted on the territory must be traceable from the donor to the recipient and vice versa in order to safeguard the health of donors and recipients.

If a serious adverse event should occur following organ transplantation, a reporting system, put in place by Member States, should allow relevant information to be reported and transmitted.

Donor and recipient protection

Organ donation must be voluntary and unpaid. However, compensation may be granted to make good the expenses and loss of income related to the donation, while avoiding any financial incentive.

Member States shall be prohibited from advertising the need for, or availability of, organs.

Living donors are to be provided with comprehensive information as to the purpose and nature of the donation, and the consequences and risks involved.

Qualified medical personnel are to select donors on the basis of their health and medical history including a psychological evaluation. These provisions guarantee the quality and safety of organs.

The personal data of the donor shall be protected in line with Directive 95/46/EC. Anonymity is guaranteed.

Competent authorities

Member States shall designate the competent authorities to implement the Directive. They will, in particular, supervise the implementation of the quality and safety framework and exchanges with Member States or third countries;

Context

Over the last 20 years, the use of human organs for transplantation has increased considerably. This technique makes it possible to compensate for the failure of organs such as the liver, lungs or heart. However, this medical practice is associated with risks which this Directive aims to reduce by introducing strict standards concerning the quality and safety of organs.

Key terms used in the act
  • Organ: a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with an important level of autonomy;
  • Donor: every human source of organs, whether living or deceased;
  • Donation: donating human organs for transplantation;
  • Transplantation: the process of restoring certain functions of the human body by transferring equivalent organs to a recipient;
  • Traceability: the ability for a competent authority to locate and identify the organ at each stage in the chain from donation to transplantation or disposal, this authority, under specified circumstances set out in this Directive being authorised to: identify the donor and the procurement organisation, identify the recipient(s) at the transplantation centre(s), locate and identify all relevant non-personal information relating to products and materials coming into contact with that organ;
  • Standard operating procedures: written instructions describing the steps in a specific process, including the materials and methods to be used and the expected end product;
  • Procurement: a process by which the donated organs become available;
  • Donor characterisation: the collection of the relevant information on the characteristics of the donor needed to undertake a proper risk assessment in order to minimise the risks for the recipient and to optimise organ allocation.

Reference

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 2010/53/EU

26.8.2010

27.8.2012

OJ L 207 of 6.8.2010

Related Acts

Communication from the Commission of 8 December 2008 – Action plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States” [COM (2008) 819 final – Not published in the Official Journal].
The Action Plan on Organ Donation and Transplantation (2009-2015) sets out 10 priority actions in this area.

Rare diseases

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.

Preparing for an influenza pandemic and other health threats

Preparing for an influenza pandemic and other health threats

Outline of the Community (European Union) legislation about Preparing for an influenza pandemic and other health threats

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

Preparing for an influenza pandemic and other health threats

Acts

Commission Communication of 28 November 2005 on strengthening coordination on generic preparedness planning for public health emergencies at EU level [COM(2005) 605 final – Not published in the Official Journal].

Commission Communication of 28 November 2005 on pandemic influenza preparedness and response planning in the European Community [COM(2005) 607 final – Not published in the Official Journal].

Summary

PREPARING FOR PUBLIC HEALTH EMERGENCIES AT EU LEVEL

Purpose and scope

The general objective of the Commission communication on European coordination in the event of health emergencies is to help the Member States to draw up generic plans for all sorts of public health emergencies with the European dimension in mind. The communication and technical guidance document give the Member States a basis for devising their own general or specific plans and outline the main elements to be taken into consideration in preparing for public health emergencies.

With a view to formulating national emergency plans in the public health sphere, the Commission describes the measures which should be incorporated or taken into account in the plans for each of the following essential elements: information management, communication, scientific advice, liaison and command and control structures, preparedness of the health sector and inter-sectoral preparedness.

Information management

Information management entails the gathering, processing, use and dissemination of

  • information relating to an emergency, in order to identify the hazards and risks, monitor the
  • evolution of the emergency and determine the assets and resources available.

It is necessary to organise appropriate health surveillance at Member State level before an event occurs. To this end, surveillance standards in the different areas must be comprehensive and rigorously applied. Moreover, it is important to have collaboration with and between various sources of information (both within the public health sector and outside it, including the media, veterinary services and security services).

Communication

Information management entails the distribution of accurate and timely information. The infrastructure that is put in place must therefore be as robust as possible, so as to preserve communication channels even in emergencies when some forms of communication may be incapacitated.

Public authorities should communicate effectively with the public and the media in anticipation of events that may lead to public health emergencies, establishing themselves as the leading, if not the only, source of authoritative information about the event and its consequences.

Coordination is paramount for the transmission of accurate and coherent messages to the public. The Member States, the Commission and the competent EU agencies must strive to coordinate their crisis communications in the best possible way.

Scientific advice

Management of an emergency necessarily involves the preparation and delivery of scientific advice, covering two elements:

  • the creation, at all levels and in all areas, of structures such as expert groups or committees;
  • rapid consultation on the scientific and technical basis for assessing and examining risks so as to make clear the options for response.

At Community level, mechanisms and structures for providing scientific advice have been set up in different sectors:

  • the European Centre for Disease Control (ECDC);
  • the European Medicines Evaluation Agency (EMEA);
  • the Joint research Centre (JRC);
  • the European Food Safety Authority (EFSA);
  • the European Environment Agency (EEA);
  • the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA);
  • the European Agency for Occupational Safety and Health (OSHA).

In the area of communicable diseases, a coordinated real-time forecast modelling capability is being set up at EU level. This will help to identify the most appropriate ways of countering the spread of disease and agents, and to assist authorities by informing public health policy and forward planning.

Liaison and command and control structures

Command and control encompasses all planning and response functions and operations. In particular, command and control structures are required to arrest the spread of disease or contamination among the population and in the environment.

The requirements for effective command and control include:

  • knowledge of the situation in terms of casualties and resources;
  • response and communications coordination;
  • information analysis and management.

Command and control structures help those in charge to operate effectively, despite the complexity of the situation (uncertainty, conflicting or incomplete information, etc.). In this connection, simulation can provide a valuable tool for tackling the complexity and anticipating the outcome.

Command and control centres in the Member States need to have good systems for liasing with other Member States, the Commission, Community agencies and international organisations, in particular the World Health Organisation (WHO). The Community has many liaison systems, most of which are geared to early warning and rapid alert. Notification of a health threat through the early warning and response system or the Community rapid alert system for biological, chemical and radio-nuclear attacks and threats may lead to the recognition of a public health emergency and to the activation of appropriate liaison and coordination structures at EU level and within the Commission. Furthermore, the Commission has set up the ARGUS system, which interlinks all the Community rapid alert systems, and a crisis centre with appropriate coordinating structures.

Preparedness of the health sector

Health sector preparedness covers several aspects:

  • exchange of information between Member States on the national planning principles (including sharing of information on planned activities and assistance);
  • pooling of resources for epidemiological and laboratory investigations;
  • strengthening of procedures for transferring patients from one Member State to another;
  • introduction of isolation procedures;
  • development of new medicinal products and medical services. In this area, an EU-wide effort is needed to guarantee equitable access to essential medicinal products and to ensure the provision of adequate reserve supplies. A Community strategy for the development and production of priority medicinal products to counter the main health threats is also necessary. The Community has already taken a series of initiatives to ensure the availability of antivirals and vaccines in the event of an influenza pandemic.

Preparedness in other sectors and inter-sectorally

The mechanisms required to deal with public health emergencies beyond the health sector work in two ways, serving to:

  • assist the public health authorities in medical interventions;
  • perform activities which fall mainly within the responsibility of sectors other than public health (logistics, decontamination, transport, telecommunications, civil protection and civil defence operations, maintenance of public order, etc.).

The application of certain measures will require the intervention of authorities other than health services and will therefore entail coordination between them.

The preparedness of third countries is also crucial for protecting the European Union against health risks that may arise in those countries. Thought therefore needs to be given to a coordinated approach within and outside the EU in order to protect citizens from known or unforeseen health risks.

EU PREPAREDNESS AND RESPONSE PLANNING FOR AN INFLUENZA PANDEMIC

In March 2004, the European Commission adopted the first Community influenza pandemic preparedness plan (COM(2004) 201 final). This strategy establishes the respective roles of the Commission and the Member States in preparing for a pandemic, and outlines the key measures to be taken at certain pre-defined stages and levels, primarily concerned with management and coordination, surveillance, prevention, alleviation and response, communication, civil protection and research. This strategy is constructed mainly around the recommendations of the World Health Organisation (WHO).

The communication of 28 November 2005 on pandemic influenza preparedness seeks to review this strategy in the light of new developments in the field, namely:

  • the publication of revised WHO recommendations concerning pandemic influenza;
  • the setting up of the European Centre for Disease Prevention and Control (ECDC).

The six phases of an influenza pandemic

The action plan sets out an EU response proposal for each of the six phases of an influenza pandemic as defined by the WHO:

  • Phase 1 – inter-pandemic period: no new influenza virus subtypes detected in humans;
  • Phase 2 – inter-pandemic period: no new influenza virus subtypes detected in humans, but a circulating animal influenza virus poses a heightened risk of human disease;
  • Phase 3 – pandemic alert period: human infection with a new subtype, but no human-to-human spread;
  • Phase 4 – pandemic alert period: small cluster(s) with limited human-to-human transmission but spread is highly localised, suggesting that the virus is not well adapted to humans;
  • Phase 5 – pandemic alert period: larger cluster(s) but human-to-human spread still localised, suggesting that the virus is increasingly becoming adapted to humans, although not yet fully transmissible (substantial pandemic risk);
  • Phase 6 – pandemic period: increased and sustained transmission in the general population. Several outbreaks in at least one country outside the EU with human-to-human transmission and spread to other countries.

Determining responsibilities at Community and national levels

For each phase of the pandemic, the action plan sets out in detail the respective responsibilities of the Member States, the Commission and the ECDC. At the operational level, the measures to be taken are presented in terms of:

  • planning and coordination;
  • assessment and monitoring;
  • prevention and containment;
  • health system response;
  • communication between Member States and the EU, and to the public.

BACKGROUND

The terrorist attacks that occurred in the United States in September 2001 demonstrated the need for stronger public health policies, contingency plans and resources geared to preventing this type of attack and limiting the effects.

The SARS epidemic of 2003, constituting another major event in the public health field, resulted in a major re-think of defences against communicable diseases. It provided a test of the usefulness of the EU’s coordination activity based on the early warning and response system. Thanks to this system, the Member States were kept informed of the situation and were able to make preparations to halt any spread of the disease.

The twentieth century has also experienced three influenza pandemics. Recently, the risk of a new global influenza pandemic had to be re-assessed following the appearance of avian influenza in Asia and its spread in the world. Although there is no way of forecasting when the next pandemic might start, the repercussions of such an event would be considerable, not only in terms of mobilising the health and social services but also in terms of social and economic upheaval. Methodical preparedness planning and action at EU and Member State level can help to attenuate the extent and consequences of a pandemic.

The Commission has accordingly adopted two action plans designed to prepare the Community and the Member States for confronting public health threats at European level. One plan aims to enhance European coordination in the event of public health emergencies by providing for a general strategy applicable to different types of health threat, whether they are anticipated (like pandemic influenza) or unforeseen (like an epidemic similar to SARS). The other is concerned more specifically with preparing for and responding to an influenza pandemic.

Related Acts

Council conclusions of 18 October 2005 on avian and pandemic influenza [Not published in the Official Journal].

Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for disease prevention and control [Official Journal L 142 of 30.04.2004].

Commission Working Document of 26 March 2004 on Community Influenza Pandemic Preparedness and Response Planning [COM(2004) 201 final – Not published in the Official Journal].

Commission Decision 2000/57/EC of 22 December 1999 on the early warning and response system for the prevention and control of communicable diseases under Decision No 2119/98/EC of the European Parliament and of the Council [Official Journal L 21 of 26.01.2000].

Radiological protection for persons undergoing medical examination or treatment

Radiological protection for persons undergoing medical examination or treatment

Outline of the Community (European Union) legislation about Radiological protection for persons undergoing medical examination or treatment

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

Radiological protection for persons undergoing medical examination or treatment

Document or Iniciative

Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure, and repealing Directive 84/466/Euratom.

Summary

This Directive repeals Directive 84/466 Euratom laying down basic measures for the radiation protection of persons undergoing medical examination or treatment. It also supplements Directive 96/29/Euratom.

Objective and scope

Medical exposure continues to constitute the major source of EU citizens’ exposure to artificial sources of ionising radiation. However, the use of ionising radiation has allowed great progress in many areas of medicine. It is therefore essential that practices involving medical exposure are carried out in optimised radiation protection conditions. This is also the objective of this Directive.

The Directive applies to the following types of exposure:

  • exposure of patients as part of their own medical diagnosis or treatment,
  • exposure of individuals as part of occupational health surveillance,
  • exposure of individuals as part of health screening programmes,
  • exposure of individuals voluntarily participating in medical research programmes,
  • exposure of individuals as part of medico-legal procedures.

Justification

Medical exposure must show a sufficient net benefit compared with the individual detriment that the exposure might cause, taking into account the benefits and risks of available alternative techniques.

All individual medical exposures must be justified in advance, taking into account the specific objectives of the exposure and the characteristics of the individual involved. Cases of medical exposure for biomedical and medical research must be examined by an ethics committee, set up in accordance with national procedures and/or by the competent authorities.
Special attention must be given to the justification of medical exposures for medico-legal purposes.

In general, exposure which cannot be justified should be prohibited.

Optimisation

All doses due to medical exposure must be kept as low as reasonably achievable consistent with obtaining the required diagnostic information.

Member States must promote the establishing and use of diagnostic reference levels for radiodiagnostic examinations, having regard to European diagnostic reference levels.

For each medical research project, Member States must ensure that:

  • the individuals concerned are participating voluntarily,
  • those individuals are informed about the risks of this exposure,
  • a dose constraint is established for individuals for whom no direct medical benefit is expected from this exposure,
  • in the case of patients who voluntarily agree to undergo an experimental diagnostic or therapeutic practice and who are expected to receive a diagnostic or therapeutic benefit from this practice, the target levels of doses shall be planned on an individual basis by the practitioner and/or prescriber.

Member States must ensure that dose constraints are established for exposure of individuals in contact with exposed patients. Instructions must be handed out before the patient leaves the medical institution.

Clinical responsibility

Member States must ensure that any medical exposure is effected under the clinical responsibility of a practitioner.

Procedures

Written protocols for every type of standard radiological practice must be established for each piece of equipment. In addition, recommendations concerning referral criteria for medical exposure must be made available to the prescribers of medical exposure.

Radiotherapeutic practices must be carried out with the assistance of a medical physics expert. For radiological practices, such an expert may be consulted on an advisory basis.

Clinical audits must be carried out in accordance with national procedures, and corrective measures must be taken where diagnostic reference levels are consistently exceeded.

Training

Member States must ensure that practitioners receive theoretical and practical training. Continuing training must be provided after qualification. Member States must also encourage the introduction of a course on radiation protection in the basic curriculum of medical and dental schools.

Equipment

Member States must take steps to avoid the unnecessary proliferation of radiological equipment. They must ensure that all radiological equipment in use is kept under strict surveillance regarding radiation protection, that an up-to-date inventory is available to the competent authorities, and that appropriate quality assurance programmes are implemented by the holder of the installation. Acceptance testing must be carried out before the first use of all equipment, and thereafter performance testing on a regular basis, and after any major maintenance procedure.

The competent authorities must ensure that the holders of radiological installations take the necessary steps to improve inadequate or defective features of the equipment.

In the case of fluoroscopy, examinations without an image intensification or equivalent techniques are prohibited. Moreover, fluoroscopic examinations without devices to control the dose rate shall be limited to justified circumstances.

Special practices and protection

Appropriate radiological equipment, practical techniques and ancillary equipment must used for medical exposure:

  • of children,
  • as part of a health screening programme,
  • involving high doses to the patient.

Special attention must be given to the protection of women during pregnancy and while breast-feeding.

Accident prevention

Member States must ensure that all reasonable steps are taken to reduce the probability and magnitude of accidental or unintended doses to patients.

Estimates of population doses

Member States must ensure that the distribution of individual dose estimates from medical exposure is determined for the population and, where necessary, for relevant reference groups.

Inspection

Member States must ensure that the provisions introduced in compliance with this Directive are enforced by means of an inspection system.

References

Act

Entry into force

Deadline for transposition in the Member States

Official Journal

Directive 97/43/Euratom

09.07.1997

13.05.2000

OJ L 180 of 09.07.1997

Related Acts

Council Directive 89/618/Euratom of 27 November 1989 on informing the general public about health protection measures to be applied and steps to be taken in the event of a radiological emergency [Official Journal L 357 of 7.12.1989]