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Preventing HIV/AIDS

Outline of the Community (European Union) legislation about Preventing HIV/AIDS

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

Preventing HIV/AIDS (Council conclusions of 2005)

The HIV/AIDS epidemic and the related underlying phenomena fuelling the spread of the epidemic are common. The Council therefore adopted a series of conclusions encouraging the Member States and the Commission to step up their efforts to tackle the epidemic.

Document or Iniciative

Conclusions of the Employment, Social Policy, Health and Consumer Affairs Council of 3 June 2005 on combating HIV/AIDS [Not published in the Official Journal].

Summary

Current situation

The HIV/AIDS * epidemic and the related underlying phenomena fuelling the spread of the epidemic continue to be a major threat to public health. AIDS causes human suffering and disability, increases the risk of social exclusion, and has negative implications for national economies.

As well as continuing to strengthen existing methods to prevent the disease, it is still necessary to further develop research, surveillance, and methods for effective intervention.

The HIV/AIDS epidemic is fuelled to a great extent by social factors, such as inequality between women and men, poverty and social marginalisation of the most vulnerable populations.

Effective prevention of the epidemic requires increased cooperation between the Commission, Member States, accession, candidate and neighbouring countries, and international organisations such as UNAIDS *, with the participation of people living with HIV/AIDS and the civil society concerned.

European framework for AIDS prevention

The Council’s conclusions are based on a series of measures and conferences related directly or indirectly to AIDS prevention, in particular:

the Council Recommendation of 18 June 2003 on the prevention and reduction of harm associated with drug dependence;
the declaration adopted following the Conference “Breaking the Barriers – Partnership to fight HIV/AIDS in Europe and Central Asia” (Dublin, 23/24 February 2004), which called for the European Union’s capacity to fight the spread of HIV/AIDS to be strengthened;
the “Vilnius Declaration” adopted following the Ministerial Conference “Europe and HIV/AIDS – New Challenges, New Opportunities” (Vilnius, Lithuania, 17 September 2004), highlighting the need for joint efforts to strengthen comprehensive prevention activities and build effective partnerships between governments, civil society and the private sector;
the Commission working paper of 8 September 2004 “Coordinated and integrated approach to combat the HIV/AIDS epidemic within the European Union and in its neighbourhood”;
the Communication from the Commission, COM(2004) 0726 final, of 26 October 2004 on a coherent European policy framework for external action to confront HIV/AIDS, malaria and tuberculosis.

Action at national level

In light of the above, the Council encourages Member States to adopt measures to:

implement the Dublin Declaration and the Vilnius Declaration;
implement national multi-sectoral HIV/AIDS coordination structures, strategies and financing plans;
raise public awareness of prevention of HIV infection and provide better information on sexual and reproductive health *;
take further action to promote safer and more responsible sexual behaviour and practices, including condom use, and scale up access for injecting drug users to prevention, drug dependence treatment and harm reduction services;
counsel and support people with the virus, their families and their friends, and maintain a respectful, non-discriminatory and accepting societal atmosphere and behaviour towards people with HIV/AIDS;
develop a sustainable, affordable, and accessible health care system as a basis for prevention, treatment, and care activities, and ensure that all those in need have access to affordable anti-retroviral * treatment;
improve cooperation between clinical trials in the continuing search for HIV-vaccines and microbicides;
continue to work closely together with the European Commission and other relevant international organisations and agencies when planning and agreeing specific bilateral actions in the context of neighbourhood and development policy.

Action at Commission level

The Council calls upon the Commission to:

support Member States in their efforts to implement the Dublin and Vilnius Declarations;
contribute to efforts to improve general knowledge and to raise public awareness of prevention of HIV infection;
contribute to activities intended to establish a respectful, non-discriminatory and accepting societal atmosphere and behaviour towards people with HIV/AIDS;
facilitate the use of existing EC financing instruments for the implementation of comprehensive national HIV/AIDS strategies within the Member States and in neighbouring countries;
promote investment in the appropriate research and development of effective behavioural and risk-reducing as well as prophylactic measures and cure;
encourage the European Centre for Disease Prevention and Control to further reinforce and coordinate activities on the surveillance of communicable diseases, including HIV/AIDS;
facilitate collaboration between the Member States, accession, candidate and neighbouring countries and relevant international organisations in order to promote the exchange of good practices and joint projects;
promote dialogue and cooperation with countries at regional and global levels, as well as with international organisations such as UNAIDS.

Key terms used in the act
HIV: the acronym HIV stands for “human immunodeficiency virus”. AIDS: the acronym AIDS stands for “acquired immunodeficiency syndrome”. UNAIDS: UNAIDS is a partnership between various United Nations bodies, the World Health Organisation and the World Bank. As the main advocate for global action against HIV/AIDS infection, UNAIDS leads, strengthens and supports an expanded response to the epidemic in order to: prevent transmission of HIV; provide care and support; reduce the vulnerability of individuals and communities to HIV/AIDS infection; alleviate the impact of the epidemic. It plays a crucial role in managing and disseminating knowledge and information on the epidemic and on global action. Reproductive health: reproductive health refers to a series of conditions, events and processes which occur during life, from smooth sexual development, intimate sexual relations and motherhood to abuse, illness, disability and death. It is closely linked to a person’s values, culture and vision of the future. Reproductive health thus covers not only family planning but also areas such as sex education, safe pregnancy, control of sexually-transmitted diseases and incorporation of an approach based on gender equality. Antiretroviral treatment: the objective of antiretroviral treatment is to achieve maximum reduction in viral load for as long a period as possible in order to keep the disease in check. The treatment therefore does not rule out HIV. It involves several different drugs and must be continued throughout life.

Key terms used in the act

HIV: the acronym HIV stands for “human immunodeficiency virus”.
AIDS: the acronym AIDS stands for “acquired immunodeficiency syndrome”.
UNAIDS: UNAIDS is a partnership between various United Nations bodies, the World Health Organisation and the World Bank. As the main advocate for global action against HIV/AIDS infection, UNAIDS leads, strengthens and supports an expanded response to the epidemic in order to: prevent transmission of HIV; provide care and support; reduce the vulnerability of individuals and communities to HIV/AIDS infection; alleviate the impact of the epidemic. It plays a crucial role in managing and disseminating knowledge and information on the epidemic and on global action.
Reproductive health: reproductive health refers to a series of conditions, events and processes which occur during life, from smooth sexual development, intimate sexual relations and motherhood to abuse, illness, disability and death. It is closely linked to a person’s values, culture and vision of the future. Reproductive health thus covers not only family planning but also areas such as sex education, safe pregnancy, control of sexually-transmitted diseases and incorporation of an approach based on gender equality.
Antiretroviral treatment: the objective of antiretroviral treatment is to achieve maximum reduction in viral load for as long a period as possible in order to keep the disease in check. The treatment therefore does not rule out HIV. It involves several different drugs and must be continued throughout life.

Related Acts

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].

Council Recommendation of 18 June 2003 on the prevention and reduction of health-related harm associated with drug dependence [Official Journal L 165 of 03.07.2003].

of the European Parliament and of the Council of 15 July 2003 on aid to fight poverty diseases (HIV/AIDS, tuberculosis and malaria) in developing countries [Official Journal L 224 of 06.09.2003].

Communication from the Commission of 21 February 2001 to the Council and the European Parliament – Programme for action: accelerated action on HIV/AIDS, malaria and tuberculosis in the context of poverty reduction [ final – Not published in the Official Journal].

Suitability of blood donors

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Suitability of blood donors

Outline of the Community (European Union) legislation about Suitability of blood donors

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

Suitability of blood donors

Document or Iniciative

Council Recommendation of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the European Community [Official Journal L 203 of 21.7.1998].

Summary

Awareness

The Member States ought to make donors aware of:

the benefits to patients of blood and plasma donations;
the risk of infectious diseases being transmitted by blood and blood products, and the resultant need for a medical history, a physical examination and the testing of donations;
the reasons why they should not provide donations, in the interests of both their own health and the safety of recipients;
the possibility of asking questions and of withdrawing from the donation process at any time.

Information given to donors

Donors are given an assurance that they will be contacted by the blood collection centre if test results show evidence of any pathology.

Donors are informed of the measures taken to ensure the confidentiality of any information relating to their health and their donation. They have the option of requesting that the medical staff should not use their donation.

Information provided by donors

Donors should provide to the blood and plasma collection establishment the following details:

their identity, attested by a valid official document;
information on their health and medical history, including any behavioural characteristics that may affect the quality of the donation, by way of a written questionnaire and an interview with a trained medical staff member;
their signature on the said questionnaire, alongside that of the medical staff member conducting the interview; their agreement that their donation(s) may be used and their written consent confirming that they wish to continue with the donation process.

Identification/registration system

The Member States should ensure that an identification/registration system is set up for the purpose of:

identifying every collection establishment;
identifying prospective donors in such a way that verification is possible each time a donation is made;
future traceability of donations through the keeping of records on donors and prospective donors, ensuring unique identification with all the necessary guarantees of confidentiality;
allowing the inclusion of information relating to adverse donor reaction to a donation and reasons for preventing an individual from making a donation, whether temporarily or permanently, whilst ensuring confidentiality.

Donor suitability

The criteria for acceptance of donors should be clearly indicated in every donation centre and explained to the donors.

The Member States must ensure that a donation will not adversely affect the health of a future recipient or of the donor. A prospective donor’s suitability must be determined at each donation session, with steps being taken to prohibit or phase out the use of “replacement donors”. Moreover, a responsible physician is required to give his/her written authorisation at the final stage of determining the suitability of a prospective donor whose eligibility is questionable.

The Member States must take steps to exclude permanently or temporarily from the donation process persons who display any of the conditions and characteristics listed in sections B and C of Annex II.

The exclusion of any prospective donor, whether permanent or temporary, must be recorded in a file, indicating the reasons.

Confidentiality

The Member States must ensure the confidentiality and security of sensitive medical information about prospective donors. They are required to put in place procedures for resolving data discrepancies and to prevent the unauthorised disclosure of information, while ensuring the traceability of donations.

Protection of donors’ health

Annex III of the Recommendation sets out common standards for the protection of donors’ health, particularly as regards:

the maximum volumes of blood and plasma to be collected during a single donation and over a 12-month period;
the minimum time interval between donations.

Medical attention must be made available to the donor if the donation gives rise to an adverse event.

The Member States should ensure that a sample of every donation is tested for diseases transmissible by blood and that re-testing is carried out on blood samples found to be reactive in an initial screening test.

Encouragement of voluntary donation

The Member States should take all the necessary measures to encourage the voluntary and unpaid donation of blood and plasma.

Related Acts

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 of 08.02.2003].
This Directive lays down high standards of quality and safety for human blood and blood components throughout the Community, with the aim of putting in place a full set of binding rules across the entire “transfusion chain”.

Antibiotic resistance

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Antibiotic resistance

Outline of the Community (European Union) legislation about Antibiotic resistance

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

Antibiotic resistance

Document or Iniciative

Council Resolution of 8 June 1999 on antibiotic resistance: a strategy against the microbial threat [Official Journal C 195 of 13.07.1999]

Summary

Antibiotic resistance is a major European and global health problem. Antibiotic resistance increases morbidity and mortality due to communicable diseases, which leads to a diminution in the quality of life and also to additional health and medical care costs.

Antibiotics are indispensable in combatting infectious diseases and it is therefore imperative to preserve the effectiveness of those medicinal products which are still effective.

Antibiotic resistance and its various causes need a multidisciplinary and cross-sectoral approach. National initiatives are not enough to reduce the risks and to effectively prevent micro-organisms from becoming resistant to antibiotics used in human and veterinary medicine and in animal feedingstuffs, nor can they preserve the effectiveness of antibiotics in the treatment of infectious diseases. A common strategy and coordinated action are required at Community and international levels.

Bearing in mind the global dimension of this problem, the Member States and the Commission must actively promote the aims of this resolution in international organisations, in particular in the World Health Organisation (WHO), the UN’s Food and Agricultural Organisation (FAO) and the International Office of Epizootics (OIE).

According to the Council, the overall strategy should be based on risk assessment using established scientific findings and comprise coordinated control and preventive action (for example in relation to surveillance of antibiotic resistance in humans, animals and foodstuffs and its effects, infection control in health care and infection control in animal production, development of new therapeutic and preventive medicaments, etc) and research work (notably on the effects of preventive measures, the development of new antibiotics and alternatives, the best use of antibiotics, determinants which increase the risk of emergence of antibiotic resistance, mechanisms of the spread and development of antibiotic resistance, or best farming practice so as to improve animal health).

In the context of this strategy, Member States are called upon:

to establish multi-disciplinary and cross-sectoral policies in order to facilitate the containment of the spread of antibiotic resistance;
to cooperate in order to enable an effective comparable monitoring of the supply and use of antibiotics and an effective comparable surveillance of antibiotic resistance;
to maintain the principle of antibiotics authorised as human and veterinary medicine being “prescription-only-medicines” and to ensure vigilance on the implementation of this principle;
to promote adherence to the principles of infection control both in hospitals and non-hospital care as well as in animal production;
to promote optimal prescribing and use of antibiotics (through professional education, guidelines, etc.) and to prevent their unnecessary and inappropriate use in human and veterinary medicine;
to promote actions aimed at raising the awareness of health professionals, farmers and the general public of the problem of antibiotic resistance;
to promote health orientated animal production systems, thus reducing the need for antibiotics;
to promote research in this area;
to cooperate closely with the Commission, in particular in the aforementioned areas.

The Commission is invited:

to include as a priority the surveillance of antibiotic resistance in human medicine and in the field of zoonosis control and to promote – through the Community network for the epidemiological surveillance and control of communicable diseases – the complementarity of this surveillance;
to ensure, on the basis of comparable data provided by Member States, the reporting, including conclusions, on the supply and use of antibiotics in particular in human and veterinary medicine as well as in animal feeding, horticulture and other agricultural productions and foodstuffs;
to support the exchange of experience and information concerning the rational usage of antibiotics by appropriate Community activities;
to promote research work in the implementation of the Fifth Research Framework Programme with regard to the evolution of antibiotic resistance within bacterial populations and the understanding of the transmissibility of resistant bacteria in humans, animal populations and the environment;
to consider the advisability of preparing a proposal for a Recommendation in accordance with the Treaty;
to examine the necessity of reviewing current Community legislation in the areas of human and veterinary medicine;
to pay particular attention to the problem of antibiotic resistance in specific health actions related to applicant countries, in particular in the framework of the Phare 2000 programme.

The Commission should promote cooperation in close coordination with the Member States and the competent international organisations.

Prudent use of antimicrobial agents in human medicine

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Prudent use of antimicrobial agents in human medicine

Outline of the Community (European Union) legislation about Prudent use of antimicrobial agents in human medicine

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

Prudent use of antimicrobial agents in human medicine

Document or Iniciative

Council Recommendation of 15 November 2001 on the prudent use of antimicrobial agents in human medicine [COM(2001) 333 final Volume II – Not published in the Official Journal].

Summary

Background

The proposal follows on from the Commission Communication setting out a strategy to address the disturbing problem of resistance to antimicrobial agents.

The Recommendation will be implemented in close cooperation with the network on epidemiological surveillance and control of communicable diseases established in 1999. The network supplies important information on the spread of communicable diseases for which antimicrobial agents constitute the main method of treatment.

Main areas of action

There are six main strands to the Recommendation:

surveillance;
control;
prevention;
education;
information;
research.

The measures are, in the main, to be implemented by a national organisation in each Member State, which is responsible for drawing up a general strategy for this purpose. The Commission is to be provided with a strategy plan within one year of adoption of the Recommendation, and this plan must be put in place progressively over a period not exceeding four years. The Member States must submit a report on implementation of the measures within one year and subsequently on an annual basis.

Surveillance

This entails establishing or improving surveillance systems for antimicrobial resistance and the consumption of antimicrobial agents in order to gather reliable and comparable data on the susceptibility of pathogens to antimicrobial agents and on the prescription and consumption of these agents. The information is intended to allow analysis of the development of the problem and to potentially link prescription and consumption of antimicrobial agents to the development of pathogens resistant to those agents.

Prevention and control

Principles and guidelines are to be developed on good practice in disease management. Important elements are disease prevention and the control of agents.

It is essential to enforce control measures on the prudent use of antimicrobial agents. The main objective is to ensure that antibacterial agents are only available on prescription. Initially, for agents not subject to the prescription-only requirement, this means setting rules for their use. Whether it is necessary to apply this rule to all antimicrobial agents as a precautionary measure should also be examined. The Commission and the Member States will work together on establishing the monitoring indicators for prescription practices.

Disease prevention and restricting the use of antimicrobial agents are two important aspects in combating microbial resistance. This means optimising the choice of medicament, dose and duration of the treatment. Where the prevention of communicable diseases is concerned, it is a question in particular of promoting and reinforcing immunisation programmes and hygiene and infection control measures in institutions (hospitals, childcare facilities, nursing homes, etc.).

Education and information

Education of health professionals is essential for the implementation of measures to tackle this problem. This includes teaching principles and guidelines on the appropriate use of antimicrobial agents and focussing on training on hygiene and infection control standards and on immunisation programmes.

Information campaigns to increase awareness among the general public as consumers of antimicrobial agents can also play an important role.

Research

The Member States are under an obligation to inform the Commission and the other Member States of national research initiatives in this field.

It is important to focus on research on:

the mechanisms of emergence and spread of antimicrobial resistance;
developing new means of preventing and treating infections;
developing alternatives to antimicrobial agents.

Provisions concerning products

The Recommendation contains provisions in respect of the products themselves. Control systems for the marketing of antimicrobial agents are to be put in place within two years to ensure that it complies with the principles of good management of communicable diseases.

The Commission and the Member States will also initiate activities to harmonise and update product information.

Role of the Commission

The Commission will have a coordinating role, facilitating information, consultation and cooperation. It will also be responsible for establishing texts on principles and guidelines for best practice on the prudent use of antimicrobial agents. The Commission is to set up a Community information system linking prescribers, pharmacists, etc. and the general public. It is also necessary to step up the participation of the applicant countries within the framework of the Network on epidemiological surveillance and control of communicable diseases in the Community.

Related Acts

Report from the Commission of 22 December 2005 on the basis of Member States’ reports on the implementation of Council Recommendation (2002/77/EC) on the prudent use of antimicrobial agents in human medicine [COM(2005) 684 final – Not published in the Official Journal].

The report states that Member States have implemented only some of the various measures proposed in the Recommendation. For this reason the Commission calls on the Member States to comply with all of the Recommendation’s provisions, and in particular to:

prioritise the speedy development and efficient implementation of the National Strategies and National Action Plans;
tackle the problem of self-medication with antibiotics, in particular by educating the general public about the risks involved;
draw up guidelines recommending appropriate antibiotic treatment;
extend monitoring activities to include antivirals and antiparasitic agents;
promote EU-wide exchange of best practice.

Essential medicines for developing countries

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Essential medicines for developing countries

Outline of the Community (European Union) legislation about Essential medicines for developing countries

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

Essential medicines for developing countries (HIV/AIDS, tuberculosis and malaria)

Document or Iniciative

Council Regulation (EC) 953/2003 of 26 May 2003 to avoid trade diversion into the European Union of certain key medicines.

Summary

Scope

This Regulation applies to any pharmaceutical product used in the prevention, diagnosis and treatment of the following communicable diseases: HIV/AIDS, malaria and tuberculosis. It does not apply to goods of a non-commercial nature contained in travellers’ personal luggage for personal use within the limits laid down in respect of relief from customs duty.

The list of countries of destination can be found in Annex 2 to the Regulation. There are 76 countries listed.

Principle of tiered pricing

In order for pharmaceutical products to qualify as tiered priced products, their manufacturers or exporters of products must submit applications to the Commission. This application must specify:

the product’s name and composition as well as sufficient information to verify which disease it is preventing, diagnosing or treating;
the proposed price;
the countries of destination.

If the Commission, assisted by a committee of representatives of the Member States, decides that the application fulfils the criteria set out in the Regulation, the product is added to Annex 1 and the applicant informed within 15 days of the date of the decision.

Setting tiered prices

When setting a tiered price, the applicant manufacturer or exporter has two options:

25 % of the average ex-factory price charged in OECD markets;
the direct production costs plus 15 %.

General obligation

It is illegal to import into the Community tiered priced products for the purposes of entry, release for free circulation, re-export, placing under suspensive procedures or placing in a free-zone or free warehouse.

Identification of tiered priced products: marking with a logo

Once a product has been approved as a tiered priced product the manufacturer and exporter affix a logo (see Annex 5) on all packaging, products and documents used in connection with the approved product.

Manufacturers and exporters of tiered priced products sold in the poorest developing countries may, in addition, identify these products by affixing the text “Approved as tiered priced product by EC under Regulation …….” in any of the official languages of the European Union on any packaging or by differentiating the product in a way as may seem fit.

Any additional information (means of transport, trading routes, batch-numbers, etc.) available to the exporter should be made available to the customs authorities to assist them in identifying tiered priced products.

Controls performed by the Member States’ customs authorities

The customs authorities will suspend the release of, or detain, tiered priced products for as long as is necessary to obtain a final decision from the competent authorities on the nature of the goods in question.

If imported products are recognised by the competent authority as tiered priced products, that authority will issue a decision instructing the customs authority to destroy these products unless the importer is prepared to make the goods available for humanitarian purposes to the benefit of countries listed in Annex 2. Destruction is normally carried out at the expense of the importer but in any case without cost to the exchequer.

Where imported products are found not to qualify as tiered priced products as defined in this Regulation, the competent authority issues a decision to that effect enabling the customs authority to release the products to the consignee.

Monitoring the volume of exports of tiered priced products

Manufacturers and exporters are obliged to submit annual reports to the Commission on the volume of sales of each tiered priced product. On the basis of these reports, the Commission reports to the Council on the volumes exported.

Intellectual property law

This regulation has been laid down in parallel with the debate in the WTO’s TRIPs (Trade-Related Aspects of Intellectual Property Rights) Council on the possibility of allowing the developing countries, in health emergencies, to obtain compulsory licences to manufacture the medicines they need.

If the countries in question obtain the medicines they need through tiered pricing, as the proposal for a Regulation suggests, they will not need such compulsory licences.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) 953/2003	4.6.2003	–	OJ L 135 of 3.6.2003

Subsequent amendments and corrections to Regulation (EC) 953/2003 have been incorporated in the basic text. This consolidated version has a purely documentary value”.