Moldovan patients and CSOs stood against the patent monopoly on bedaquiline

Chisinau, Moldova © via iStock

In 2019, 1.4 million people died from tuberculosis (TB) – which is the leading cause of death among people living with HIV. Trials of newer TB drugs have found that they are safe and effective against drug-resistant (DR) forms of TB, but high prices have limited access to these medicines.  

The Republic of Moldova has one of the world’s highest burdens of drug-resistant TB (DR-TB, making access to affordable and optimal treatment a priority.  On April 14, Positive Initiative, an MMA partner in Moldova working on access to affordable medicines for HIV, viral hepatitis and TB, filed an invalidation lawsuit against the pharmaceutical company JANSSENPHARMACEUTICA N.V. (BDQ; brand name Sirturo). BDQ is WHO-recommended as a mainstay of all-oral regimens for MDR-TB.

Positive Initiative joined 16 civil society organizations in Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, the Republic of Moldova, the Russian Federation, Tajikistan, Uzbekistan and Ukraine in an open letter to submitted to Janssen, the patent holder for BDQ, calling on the pharmaceutical corporation  to ensure access to generic versions of BDQ in the  Eastern Europe and Central Asia region.

“There was no need to ‘reinvent the wheel’, considering that our partners from the neighboring countries were one step ahead and had been already actively working on patent oppositions.”, said Ruslan Poverga, Director at the Positive Initiative, in Moldova. “In many countries around the world patent monopolies for essential medicines are an unmanageable burden for public healthcare systems and obstruct access to life-saving medicines. But, as patent opposition is country based, companies like Janssen take advantage of the system, at the cost of people’s lives”.

The monopoly on/and overpricing of BDQ are nothing new for Eastern European and Central Asia region. Civil society organizations in Belarus (ROO “People Plus”), Kazakhstan (PF Answer), Kyrgyzstan (Association “Partner Network”) and Ukraine (CO “100 Percent Life”) have already filed oppositions against evergreening patents on BDQ. In Moldova, the basic patent for the pharmaceutical compound is valid until 2023, whilst a secondary patent would extend BDQ monopoly for extra five years – until 2028.

“This means 5 years of resources that could be allocated to other vital health needs.”, says Poverga.