WHO launches plan for cheaper TB drugs

WHO launches plan for cheaper TB drugs

Context:

• The World Health Organization (WHO) recently invited pharmaceutical companies around the world to submit proposals to manufacture affordable version of newer medicines for treatment of drug resistant tuberculosis.

Introduction:

• India has nearly 1.3 lakh DR-TB patients. However, the Health Ministry gets only 10,000 doses of Bedaquiline and 400 doses of Delaminid.
• The medicines are obtained as donations from Janssen(US) and Otsuka Pharmaceuticals(Japan), the respective manufacture.
• In the case of HIV, one company, Cipla, came up with a ‘AIDS cocktail’ combination of Stavudine, Lamivudine and Nevirapine, enabling effective treatment.

Purpose:

• The aim was to replicate the success of addressing the HIV epidemic.
• One of the aims is to achieve more competitive market and more affordable prices.
• Inclusion within the scope of PQ has also incentivised the development of fixed dose combinations, which have yielded much better results for patients.

Expression of Interest (EoI):

• WHO has requested drug makers to submit an Expression of Interest (EoI) for Bedaquiline and Delaminid, two new-generation drugs, recommended for drug resistant-TB.
• Under WHO norms, drugs submitted upon such requests and complying with its standards are included in a list for procurement by the UN and other organisations.

Trade Related Intellectual Property Rights (TRIPS):

• Cheaper drugs to treat HIV became possible at the time as the Indian Patents Act did not provide for product patents on pharmaceutical products, until required by the Trade Related Intellectual Property Rights (TRIPS) framework of the World Trade Organization (WTO).
• India became TRIPS compliant with pharma product patents in 2005.

Access to affordable drugs:

• With WHO’s backing, India will be able to accelerate introduction of generics.
• Inclusion of the two new drugs, Bedaquiline and Delaminid, in the pre-qualification call is being interpreted by aid agency Médecins Sans Frontières (MSF) as WHO’s backing for generics.

To address challenges of drug-resistant:

• WHO considers the two drugs key compounds to address challenges of drug-resistant TB.
• WHO also want to encourage generic competition to start finding ways to make these medicines available in countries where they are not yet registered.
• The EoI allows generics manufacturers interested in producing these two drugs, and currently facing technical challenges, to address their questions to WHO’s pre-qualification team.