An urgent prescription

An urgent prescription

Context

Declining public sector capacity for manufacture of essential drugs and vaccines

Why public sector is needed for manufacture of essential drugs and vaccines?

• Affordable cost: Public sector capacity for manufacture of essential drugs and vaccines is very much needed to ensure that our population is not denied access to drugs that the Indian private sector is unable to produce or supply at affordable cost
• National security & disruptions in markets: Active pharmaceutical ingredients (APIs), which are needed for drug manufacture (formulation), are now mostly imported from China. This makes India highly vulnerable to disruptions in supply and cost escalations in import. National security demands that we develop both public and private sector capacity within the country, with suitable government support and incentives, to ensure uninterrupted and inexpensive availability of APIs
• The High Level Expert Group Report on Universal Health Coverage for India (2011) clearly articulated the need for strengthening public sector units (PSUs) which have drug manufacturing capability
  • The report stated: “The use of PSUs will offer an opportunity to produce drug volumes for use in primary and secondary care facilities as well as help in ‘benchmarking’ drug costs. The existence of PSUs would also provide an opportunity to utilise the provision of Compulsory Licensing under TRIPS
• Effective implementation of the Ayushman Bharat initiative calls for investment in expanding public sector capacity for producing essential drugs and APIs. This also embodies the spirit of Make in India

What kind of drugs are we talking about?

These include drugs where compulsory licences may need to be issued by the government for patent protected drugs or even off-patent drugs which are commercially unattractive to private manufacturers

What is Compulsory licensing?

Compulsory licensing (CL) is a mechanism permitted by the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement to enable countries to issue licences to domestic drug manufacturers to produce and market affordable generic versions of life-saving drugs needed for meeting serious public health challenges that are of extreme urgency

• This allows countries to overcome patent restrictions to assure availability of such drugs when the situation demands
• Drugs effective against multi-drug resistant tuberculosis and anti-cancer drugs are clear examples of such a need, which should be addressed through compulsory licensing

Has India utilised the compulsory licensing provision earlier?

India has used the CL route previously to permit two Indian companies, Natco and Cipla, to produce a potent anti-cancer drug Nexavar manufactured & patented by Bayer. This enabled a 32-fold reduction in the cost of the drug.

Why private companies are hesitant to manufacture generic versions of the new anti-tubercular drugs?

The simple reason is the expensive litigation that followed the Nexavar case due to action initiated by Bayer

Measures by WTO

The World Health Organisation (WHO) has now invited expressions of interest from drug manufacturers to produce generic versions of two effective but expensive anti-tubercular drugs, bedaquiline and delamanid

• Patients with drug-resistant TB require a combination of both these drugs

UN High Level Panel Access to Medicines (2016)

• A report of the UN High Level Panel Access to Medicines (2016) called upon countries to safeguard and fully utilise the rights conferred by the TRIPS as confirmed by the Doha Declaration of the WTO
• It also urges member states of WTO to adopt a permanent revision of Paragraph 6 of the TRIPS agreement to enable “swift and expeditious export of pharmaceutical products produced under compulsory license”

Conclusion

India should take the lead in ensuring universal access to affordable drugs through such measures. Investment in public sector capacity is essential to ensure that the country can exercise that leadership even on occasions when the private pharmaceutical sector is hesitant to assume a leading role