Focus: GS-III Indian Economy
Why in news?
- Clinical trials with re-purposed antivirals and biologicals have been approved in different geographical settings and these medicines are believed to have some potential in shortening the recovery time in COVID-19 patients.
- Recently, the Drugs Controller General of India (DCGI) issued approval to manufacture and market Favipiravir tablets for ‘restricted emergency use’, manufacture and market injectable formulations of Remdesivir and market injectable formulations of Itolizumab.
Pricing of medicines, and Protocol
- A five-day treatment course with Remdesivir would work out to around Rs. 30 thousand per patient and a course of treatment with Favipiravir costs more than Rs. 12 thousand per patient, and treatment with Itolizumab costs around Rs. 32 thousand per patient.
- The updated clinical management protocol of the Ministry of Health and Family Welfare (MHFW) lists Remdesivir as a potential medicine for investigational therapy in moderate COVID-19 infections without underlying contra-indications. The protocol does not mention Favipiravir, which nevertheless finds a place in the WHO Clinical Management Protocol. Itolizumab figures neither in the MHFW nor in the WHO protocol.
- Hence, the current pricing shows that these crucial medicines are NOT made available at affordable prices to patients.
- When companies attempt to recover the fixed costs or sunk costs that went into the investment and development of the medicine, the final price becomes unreasonable.
- This is distressing for the patient, especially when the therapeutic results or clinical benefits have not been fully established.
Various laws
- Some countries are resorting to enabling legislation and procedural modifications of existing regulations to address affordability of anti-COVID-19 medicines.
- Indian patent laws too are armed with sufficient powers to ensure reasonable pricing for pharmaceutical products – enabling grant of compulsory licensing in circumstances of national emergency or extreme urgency.
- Many innovator companies, perhaps to escape or avoid any coercive move or legal action by governments, agree upon voluntary licences with generic companies.
Conclusion
- The burden of a global pandemic will have to be borne by governments and pharmaceutical companies alike.
- Unprecedented public health crises call for situation-specific decisions from pharmaceutical companies and profit maximisation should take a back seat.
-Source: The Hindu
