The legal imperative for treating rare disorders
| Autor: | Jeremy Manuel, Jonathan C. P. Roos, Timothy M. Cox, Hanna I. Hyry |
|---|---|
| Jazyk: | angličtina |
| Předmět: |
Orphan Drug Production
media_common.quotation_subject Legislation Public administration Orphan drug Orphan Rare Diseases media_common.cataloged_instance Humans Human rights Genetics(clinical) Pharmacology (medical) European Union European union Genetics (clinical) Reimbursement health care economics and organizations media_common Tort Medicine(all) Disability Judicial review Research General Medicine Legislation Drug Business Law Rare disease |
| Zdroj: | Orphanet Journal of Rare Diseases |
| ISSN: | 1750-1172 |
| DOI: | 10.1186/1750-1172-8-135 |
| Popis: | Background Life-saving orphan drugs are some of the most expensive medicines. European Union governments aim to accommodate their provision within stretched healthcare budgets but face pressure to reduce funding of such treatments. Patients struggle to retain or gain access to them as their special status is questioned, causing distress and in some cases, fears of premature death. In the UK and EU reimbursement and pricing model of drugs, and orphan drugs in particular, is being re-evaluated. Methods Using the United Kingdom as a case study we present, for the first time, legal arguments which compel governments to provide orphan medicinal products. These include (i) disability legislation, (ii) national and organisational constitutions, (iii) judicial review, (iv) tort law and (v) human rights legislation. We then address directly potential objections to our analysis and counter arguments which aim to limit provision of orphan drugs to the intended patient recipients. Results We demonstrate that a compelling case can be made that the law demands the treatment of orphan diseases. Conclusions Our legal framework will assist doctors and patients in ensuring the continued provision of treatments despite significant economic pressure to reduce funding. These legal avenues will empower stakeholders in drafting funding guidelines throughout the EU. The legal right to treatment extends beyond rare diseases and our analysis may therefore affect allocation of healthcare budgets throughout the EU. |
| Databáze: | OpenAIRE |
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