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Biotech examines orphan drugs' laws

The regulation of orphan drugs should be harmonised across Europe, the European biotech industry has said.

The regulation of orphan drugs should be harmonised across Europe, the European biotech industry has said.

Releasing a White Paper, Towards an Optimal Orphan Medicinal Products Framework in Europe, the industry called for European authorities to examine nine specific areas with the aim of optimising the European Orphan Drug Regulation.

The European Orphan Drug Regulation was launched in 2000 to encourage companies to develop more treatments for rare diseases.

Biotech's recommendations include undertaking an educational programme to build awareness of rare diseases in Europe and establishing a European Union-wide network for diagnostic testing.

Biotech also called for the end of regional inequalities in patient diagnosis, access and reimbursement, which were highlighted in a recent study by DG Enterprise on the price of orphan drug treatments.

Dr Erik Tambuyzer, spokesperson for the Emerging Biopharmaceuticals Enterprises and chair of the Healthcare Council at EuropaBio, said that the White Paper was ìa call for action from all European stakeholdersî.

ìThe industry has thought about what framework is needed to optimise the work on, and access to, therapies for patients with rare diseases. It is proposing a comprehensive paper with suggestions for such a framework to be worked on by all involved stakeholders.î

ìThis regulation came into being with unanimous support from all involved, including the European Parliament. And now we need that same solidarity again, to ensure that this regulation can deliver fully on its promise to patients suffering from rare disease,î he added.

According to Rare Disorders UK, an estimated 4 million people in the UK have a rare disorder, which is more than the number of people in the UK affected by coronary heart disease.

Biotech is expected to play a major role in the development of treatments for rare diseases as it is estimated that 70-80 per cent of rare diseases are genetic.

30th September 2008

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