Will generic supply of bedaquiline be accessible?

Will generic supply of bedaquiline be accessible?

Subject: Science and technology

Section: Health

Context:

• Bedaquiline has now become the cornerstone to cure drug-resistant tuberculosis (DR-TB).

Details:

• Johnson & Johnson’s patent on bedaquiline expired on July 18.
• This expiry will allow generic manufacturers to supply the drug.
• J&J has filed secondary patents over bedaquiline till 2027, which were granted in 66 low-and middle-income countries. It includes 34 countries with high burden of TB, multidrug-resistant TB (MDR-TB), and TB/HIV.

About Tuberculosis (TB):

• TB is caused by a bacterium called Mycobacterium tuberculosis, belonging to the Mycobacteriaceae family consisting of about 200 members.
• Some of Mycobacteria cause diseases like TB and Leprosy in humans and others infect a wide range of animals.
• In humans, TB most commonly affects the lungs (pulmonary TB), but it can also affect other organs (extra-pulmonary TB).
• TB is a very ancient disease and has been documented to have existed in Egypt as early as 3000 BC.
• TB is a treatable and curable disease.
• Transmission:
  • TB is spread from person to person through the air. When people with lung TB cough, sneeze or spit, they propel the TB germs into the air.
• Symptoms:
  • Common symptoms of active lung TB are cough with sputum and blood at times, chest pains, weakness, weight loss, fever and night sweats.
• Global Impact of TB:
  • In 2019, 87% of new TB cases occurred in the 30 high TB burden countries.
  • Eight countries accounted for two thirds of the new TB cases:
    • India, Indonesia, China, Philippines, Pakistan, Nigeria, Bangladesh and South Africa.
  • India reported 1.8 million TB cases between January and December 2020 as compared to 2.4 million the year before.
  • In 2019, MDR-TB remained a public health crisis and a health security threat.
• MultiDrug Resistant Tuberculosis (MDR-TB) is a strain of TB that cannot be treated with the two most powerful first-line treatment anti-TB drugs.
• Extensively Drug Resistant Tuberculosis (XDR-TB) is a form of TB caused by bacteria that are resistant to several of the most effective anti-TB drugs.

Who made bedaquiline?

• Janssen Pharmaceutical (a subsidiary of J&J) made bedaquiline around 2002.
• Following the 2012 approval of bedaquiline several research institutes further document the safety, efficacy and optimal use of bedaquiline in DR-TB regimens.
• The recent WHO recommendation of bedaquiline being a core drug for the treatment of DR-TB is largely based on the evidence produced through these collective efforts.
• However, J&J has claimed sole ownership of it, protected by its aggressive patenting strategies.

Will the drug be available in India?

• Other DR-TB drugs like linezolid have decreased in prices by over 90% with generic competition once Pfizer’s patent expired in 2015.
• Therefore, national TB programmes are waiting for the generic supply of bedaquiline from Indian manufacturers to reduce prices.
• In India, a ‘pre-grant opposition’ was filed by a patient group and two TB survivors — Nandita Venkatesan from India, and Phumeza Tisile from South Africa.
• As a result of their legal challenge, in a landmark decision before World TB Day, the Indian Patent Office rejected the U.S. corporation J&J’s secondary patent which would have extended its monopoly for four more years.
• Indian manufacturers will now be able to supply affordable, quality assured generic versions of bedaquiline in India as the primary patent expired on July 18.
• However, they will not be able to export the medicine to 34 of the 43 countries with a high burden of TB.

Will the J&J GDF deal solve the problem and make the generic of bedaquiline accessible?

• Not just yet. The GDF deal claims to cover the majority of low-and middle-income countries but some of the countries hardest hit by DR-TB will not benefit.
• Eastern European countries and China with a high burden of TB are believed to be out of the agreement.
• Countries like South Africa are not purchasing from GDF and with the ever-greening patent inforce till 2027, it will not get access to generic Bedaquiline.

Global Drug Facility (GDF):

• Since its creation in 2001,GDF has grown into a one-stop bundled procurement and supply mechanism providing a unique package of services that combine strategic procurement of TB products and coordination of market activities, with technical assistance and capacity-building for TB programmes.
• This unique approach has made GDF the largest global provider of quality-assured TB products to the public sector and was recognized by world leaders in the United Nations Political declaration of the high-level meeting of the General Assembly on the fight against tuberculosis, which encouraged all nations to utilise GDF service.