UPSC Exam Preparation: Topic of the Day – Orphan Drugs
An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease.
Orphan Drugs Act-USA
- In 1983, the Orphan Drugs Act was formulated by the government of the USA to stimulate research in the treatment of diseases that have been largely ignored by the pharmaceutical industry.
- Countries like Australia, Japan and the European Union have enacted similar laws.
- Tax breaks, extended exclusivity and high rates of regulatory success are the incentives offered by such laws.
- The laws have made it commercially attractive for pharmaceutical companies to invest in the research and development (R&D) required to find a cure for these orphan diseases.
What can be done in India?
- The Delhi high court made a number of suggestions to the government. It was pointed out that the CSR provisions under the Companies Act, 2013 could be considered and confirmed that the act of sponsoring the treatment of rare diseases would qualify as a CSR activity.
- It suggested that the government increase its investment in the health sector and recommended the development of best practices and guiding principles in relation to the treatment of rare diseases.
- Karnataka state was the first to release a Rare Diseases and Orphan Drugs Policy.
- The implementation of preventive and carrier testing as a means of reducing morbidity and mortality was recommended. It suggested the use genetic testing was suggested as a means to expedite the identification of the critical genes involved in rare diseases, as more that 80% of the rare diseases have a genetic basis.
- A recommendation was made to use education and promotion as a tool to combat delayed diagnosis and treatment.
- The policy calls for the enactment of an orphan drugs statute to allow for tax breaks, funding and exclusive marketing rights as incentives for orphan drug discovery.
- It also highlighted a feature of India’s insurance laws that puts patients suffering from rare diseases at a particular disadvantage. Private insurance companies treat genetic disorders as pre-existing conditions and on that ground, exclude them from coverage. Since most rare diseases are genetic, patients are routinely denied insurance cover.
- Insurance Regulatory and Development Authority (IRDA) was requested to re-consider this exclusion.
- It aims at making available insurance cover to rare diseases at reasonable premiums.