Govt may issue compulsory licences on diabetes drugs

Mumbai: India, with at least 60 million diabetes patients, may consider issuing compulsory licences for some patented diabetes management drugs sold in the country in an effort to make them accessible and affordable.

A committee formed by the ministry of health and family welfare to recommend ways to ensure access to essential drugs to patients will suggest that compulsory licences be issued for at least two patented therapeutic drugs, according to two people familiar with the development.

Affordability is a key issue in countries such as India with a large number of poor or low-income households and the low reach of medical insurance (less than 15% of the population has a health cover, according to a report by consultant EY, previously known as Ernst and Young).

“We have received a number of requests from health and patient groups and not-for-profit organizations for considering compulsory licensing option for several costly patented drugs in therapies, including cancer, heart diseases, HIV AIDS, diabetes among others,” said one of the two persons cited above.

The person, an official at the ministry of health and family welfare, asked not to be identified.

“Looking at the basic criteria such as size of patient population and the severity of access issue, diabetes seems an ideal case and there are possibilities for inviting the committee’s attention to requests for making diabetes therapy more affordable to Indian patients,” added this person.

The ministry is yet to identify the drugs for compulsory licensing.

“There needs to be more discussions and debate on this. The government may also try to talk to the patent holders (to provide) for voluntary licences to interested parties,” said the second person, who is a senior official at the Intellectual Property Office. This person too did not want to be identified.

A compulsory licence would allow a drug maker to use patented technology to manufacture a generic version of the product. The government can invoke the provision if a patented product is proven to be unaffordable to a large portion of local consumers or if there isn’t enough supply to meet demand.

The government resorts to issuing a compulsory licence as the final option when the patent holder is not ready to either make the product accessible to the consumer or refuses to issue a voluntary licence to another manufacturer.

 

 

 

md.aquil alam 

pgdm.1st semester 

source.mint