EEA

Health

EU instruments in the field of health and social affairs include legislation, programmes and other measures, mainly within the framework of the internal market, but also as horizontal issues. A majority of these instruments have been part of the EEA Agreement from the outset, but a substantial number have been included at a later stage in parallel with developments in the EU.

Public health
With the entry into force of the
Amsterdam Treaty in 1999, the European Union received a new basis for its activities in the public health area. Article 152 of the Treaty stipulates that a high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities. The Community is thus required to play an active role in this sector by taking measures that cannot be taken by individual States, in accordance with the principle of subsidiarity. The EU Public Health Programme is, as from January 2003, the cornerstone in this field. The aim of the programme is to contribute towards the attainment of a high level of physical and mental health and well-being and greater equality in health matters throughout the Community by improving information and knowledge for the development of public health, enhancing the capability of rapid and co-ordinated responses to health threats and preventing diseases by addressing health determinants across all policies. The EU also addresses health issues by exchanging information and developing legislation on tobacco, the safety of human tissues and cells, the safety of blood and blood products, antimicrobial resistance, electromagnetic fields, pandemics and health security. A network for the epidemiological surveillance and control of communicable diseases has also been established. The Commission has also proposed to establish a European Centre for Disease Prevention and Control. Norway has participated actively in the long-standing public health programmes of the European Union and has also, through the EEA Agreement, joined the most recent one. This will accord Norwegian applicants the same rights as applicants from EU Member States. Co-operation with the EU in this field is the responsibility of the Norwegian Ministry of Health. More information on EU activities in the field of public health is available on the public health website of DG Sanco.

Contact point at the Mission of Norway: ole.andersen@mfa.no

Contact point at the Norwegian Ministry of Health: tharald.hetland@hd.dep.no

Pharmaceutical products
Pharmaceutical products have been covered by EU legislation since 1965. New Community procedures concerning the authorisation and surveillance of pharmaceuticals entered into force in 1995, superseding various procedures based on voluntary co-operation between relevant national authorities.
The European Agency for the Evaluation of Medicinal Products (EMEA), based in London, plays a central role in this system. The aim of this reform was to pool the scientific expertise of the Member States in order to ensure a high degree of protection for public health, ensuring free movement of pharmaceuticals, and making certain that European citizens have access to new generations of medicinal products. Pharmaceuticals remain the responsibility of DG Enterprise. In 2001 the Commission launched a proposal for reforming the current system. All EU legislation relating to pharmaceuticals is part of the EEA Agreement, and Norway participates in the activities of the EMEA. Please consult the pharmaceuticals website of DG Enterprise or the EMEA website for further information. The co-operation with the EU in this field is the responsibility of the Norwegian Ministry of Health. The Norwegian Medicines Control Authority has the main responsibility for the implementation of legislation in this field.

Contact point at the Mission of Norway: ole.andersen@mfa.no

Contact point at the Norwegian Ministry of Health: jorn.nilsen@hd.dep.no

Contact point at the Norwegian Medicines Control Authority: gro.wesenberg@legemiddelverket.no

Medical devices
Legislation on medical devices is also administered by
DG Enterprise and incorporated into the EEA Agreement. This mainly entails maintaining the Community-wide legal framework for the marketing and putting into service of medical devices, thus ensuring a high level of protection for users and patients, and allowing them at the same time to benefit from technological progress and innovation. The EU is in the process of entering into mutual recognition agreements with several States, and in order to prevent legal voids, it is important that similar agreements be established between these States and the EFTA EEA States. The co-operation with the EU in this field is the responsibility of the Norwegian Ministry of Health. The Norwegian Directorate for Health and Social Affairs has the main responsibility for the implementation of legislation in this field. Please consult DG Enterprise's medical devices website for further information on this issue.

Contact point at the Mission of Norway: ole.andersen@mfa.no

Contact point at the Norwegian Ministry of Health: jorn.nilsen@hd.dep.no

Contact point at the Norwegian Directorate for Health and Social Affairs: sissel.dyrnes@shdir.no

Cosmetic products
National cosmetics regulations have been harmonised within the EU since the 1970s. The principles laid down in this regulatory field take into account the need for public health as well as the elimination of barriers to trade. The regulations aim to guarantee the safety of cosmetic products for human use, and cover labelling, packaging and safety. Control of cosmetic products within the EU/EEA is assured through the responsibility of the persons who places the product on the market, a simple notification of the manufacturing/importing site, and an in-market surveillance system. As an integral part of the internal market, the EFTA EEA States have implemented all of the EU's legislation relating to cosmetics. The responsibility for cosmetics in Norway lies with the
Ministry of Health. The Norwegian Food Control Authority has the main responsibility for the implementation of legislation in this field. For further information on EU legislation in this field, please consult DG Enterprise's cosmetics website.

Contact point at the Mission of Norway: ota@mfa.no

Contact point at the Norwegian Ministry of Health: nht@hd.dep.no

Contact point at the Norwegian Food Control Authority: maren.widme@snt.no

Health personnel
As part of the efforts to ensure the free movement of persons in the EU, and thus also in the EEA area, legislation on the mutual recognition of diplomas etc. has been developed for doctors, dentists, nurses, midwives, pharmacists and others. The responsibility for the EU legislation in this field rests with DG Internal Market. Norway participates in the advisory committees that assist the Commission in the development of this legislation, and the administrative tasks that follow from this. The system of advisory committees has now been changed to ensure a more flexible and practical management of the directives. The Commission launched in 2001 a proposal for making some revisions to the system for mutual recognition of health personnel. The co-operation with the EU in this field is the responsibility of the Norwegian Ministry of Health and Ministry of Education and Research. Please consult the DG Internal Market website for further information on this issue.

Contact point at the Mission of Norway: ole.andersen@mfa.no

Contact point at the Norwegian Ministry of Health: elisabeth.salvesen@hd.dep.no

Contact point at the Norwegian Directorate for Health and Social Affairs: inger-johanne.kramer@shdir.no

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