By – BR Sikri, Chairman FOPE and VP BDMA
An intense debate is going on in the country at present on whether patented drugs should be selected and identified for inclusion in the National List of Essential Medicines (NLEM) 2020, which is being finalised by the Expert Committee constituted by the Government, Ministry of Health.
The selection criteria for essential medicines has always been that they satisfy the priority healthcare needs of the population. Medicines which people have access at all times in sufficient amounts are safe, efficacious and available at affordable prices. Based on the said criteria, the patent is not a barrier for access to the List of Essential Medicines across the world.
WHO MLEM contains several patented medicines and the same trend is observed if we refer to NLEMs of other countries. It can be safely concluded that there is no discrimination while selecting medicines for NLEM as far as patented or non-patented medicines are concerned.
The following issues strongly suggest that patented drugs should be included in the NLEM:
1. The increasing burden of cancer and rare diseases globally
2. High cure rate is now being achieved by patented drugs especially in the treatment of cancer
3. In addition to cure, long term remission has been observed when treated with new patented drugs
4. There should be selective entries based on transparent criteria and feedback from stakeholders. This should be coupled with the treatment regimen to make them cost-effective.
5. NLEM, when made official, will be taken as a benchmark for procurement of medicines under various healthcare schemes of the Government and if essential patented drugs are excluded, the population covered under such schemes will be deprived of latest treatments.
6. The perception that NLEM is for price control of drugs under DPCO should be abandoned and its real value about the essentiality of medicines that satisfy the priority healthcare needs of the population should be on the forefront.
7. In order to achieve affordability of patented drugs, options such as CSR, voluntary third party licensing and compulsory licensing may be considered and serious dialogue should be opened with the patent holders.
We are of the opinion that carefully selected patented drugs should be included in the NLEM based on disease burden of the population. Some compelling reasons for the same have been explained above. This will be beneficial for cancer patients and for young children having rare disorders for which no treatment/ medicine is listed in the existing NLEM.