expensive-re-purposed-medicines-used-for-covid-19-treatment-summary

Context: Considering the unprecedented threat of COVID-19 pandemic issue of pricing of medicines associated need a careful assessment.

Current status of treatment of COVID-19 patients

  • The quest for developing a vaccine and finding a definitive treatment for coronavirus treatment is reportedly making decent progress. 
  • Current treatments
    • Clinical trials with re-purposed antivirals and biologicals have been approved in various countries.
      • Drug Repurposing or Repositioning is a drug development strategy predicated on the reuse of existing licensed drugs for new medical indications.
    • These medicines are believed to have some potential in shortening the recovery time in COVID-19 positive patients.
  • Scenario in India
    • Drugs Controller General of India (DCGI) recently issued an approval to Glenmark Pharma to manufacture and market Favipiravir tablets for ‘restricted emergency use’. 
    • It has also issued approvals to manufacture and market injectable formulations of Remdesivir, including to market injectable formulations of Itolizumab.

Medicines associated and their pricing

  • Remdesivir:
    • It is an antiviral originally developed by Gilead to treat the Ebola virus infection.
    • Gilead has recently entered into a royalty-free voluntary licensing agreement with various companies to provide technology transfer to manufacture Remdesivir for distribution in 127 countries.
    • The current free royalty period is valid until the World Health Organization (WHO) declares the end of the pandemic or until another medicine or vaccine is approved to treat or prevent COVID-19.
    • India has also listed Remdesivir as a potential medicine for investigational therapy in moderate COVID-19 infections without underlying contra-indications.
    • A five-day treatment course with Remdesivir would work out to Rs. 24,000-32,000 per patient.
  • Favipiravir:
    • It is a generic version of an anti-influenza medicine developed by Toyama Chemical in Japan.
    • Glenmark claims to have developed the active pharmaceutical ingredient and formulation of Favipiravir and has priced a course of treatment costing Rs. 12,566 per patient.
    • Both Remdesivir and Favipiravir inhibit viral RNA-dependent RNA polymerase, thereby retarding viral replication in host cells.
  •  Itolizumab
    • Itolizumab, as such used in the treatment of psoriasis, reportedly shows therapeutic effects in severe COVID-19 infections progressing to acute respiratory distress syndrome. 
    • Treatment with Itolizumab is also very expensive with the medical costs amounting to Rs. 32,000 per patient.

Issue of high pricing of medicines

  • Affordability of medicines remains a matter of particular concern. Considering that 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.

Enabling legislation and procedural modifications of existing regulations to address affordability

  • Akin to the flexibilities in the TRIPS agreement which helped in making antiretrovirals affordable during the AIDS crisis, some countries are resorting to similar methods now.
  • Worldwide scenario:
    • Israel issued a compulsory license for the production and import of the Lopinavir-Ritonavir combination from India.
    • Canada passed the COVID-19 Emergency Response Act and similarly, Germany passed The Prevention and Control of Infectious Diseases in Humans Act. 
    • Chile and Ecuador passed resolutions allowing TRIPS flexibilities in the pandemic
    • Prompted by Costa Rica, WHO opened a voluntary patent pool, for compiling and sharing information and technological know-how for the development of medicines, vaccines, and diagnostics for COVID-19.
  • Scenario in India
    • Indian patent laws are also armed with sufficient powers to ensure reasonable pricing for pharmaceutical products.
    • However, India has used compulsory licensing only once in 2012 for Bayer’s patented drug “Sorafenib tosylate.” 
      • It is used for the treatment of advanced stages of kidney and liver cancer.
    • The provisions in India enable the grant of compulsory licensing in circumstances of national emergency or extreme urgency

About compulsory licensing

  • It is when a government allows someone else to produce a patented product or process without the consent of the patent owner or plans to use the patent-protected invention itself. 
  • It is one of the flexibilities in the field of patent protection included in the WTO’s agreement on intellectual property the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement.
  • Compulsory licenses may not be the solution in all emergency situations. Nevertheless, the pricing will have to reflect the magnitude of the crisis and the socioeconomic realities in individual countries.

Way ahead

  • Voluntary licenses with generic companies
    • Many innovator companies, perhaps to escape or avoid any coercive move or legal action by governments may agree upon voluntary licenses with generic companies.
    • This would ultimately benefit the patients in terms of the cost associated.
  • Profit maximization should take a back seat
    • The prices announced for the re-purposed medicines appear to be high, especially given the rate of spread and the public health crisis in India.
    • On the other hand, economies of scale will also ensure that the companies recoup their investment costs, and still generate profits.
    • However, the burden of a global pandemic will have to be borne by governments and pharmaceutical companies alike. 

Drugs Controller General of India (DCGI) 

  • It is a department of the Central Drugs Standard Control Organization of the Government of India. 
  • It is responsible for the approval of licenses of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India. 
  • Drug Controller General of India, comes under the Ministry of Health & Family Welfare.
  • DCGI sets standards for manufacturing, sales, import, and distribution of drugs in India.

Source:https://www.thehindu.com/opinion/op-ed/why-are-re-purposed-medicines-expensive/article32154508.ece

Image Source: TH