While decisions on access are primarily taken at a national or more local level, there has been a long history of international coordination. Regions with strong links between nations have coordinated health technology assessment and some have sought to use their greater combined influence to achieve favourable pricing and purchasing terms. These activities are described in this international section, organised according to the same categories used for national access.
Europe has a particularly strong history of joint activities, with many multilateral initiatives between individual European countries that we cover in this section. The European Union has long taken an active role, with the European Medicines Agency having a central place in the regulation of pharmaceuticals. The centralised marketing authorisation process is described in the regulatory chapter, as is the EU pharmaceutical legislation.
EU regulatory activities are now complemented by coordinated action in the access arena. EU Joint Clinical Assessment has begun to inform the first step of the access process and is one of a wide range of collaborations described in this section, both within Europe and more widely.
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In this section subscribers can consult descriptions of the following international activities relating to key stages of the access process, with links to key sources of additional information:
- Scientific advice
- Regulatory approval
- Health technology assessment
- Pricing and procurement
- Early access
- Innovative medicines