TREATING drug-resistant tuberculosis (DR-TB) patients in the Philippines might become more expensive as cheaper yet quality-assured generic versions of its cure will be restricted in the domestic market.
This concern arose as the expiration of Johnson & Johnson’s (J&J) 20-year primary patent for DR-TB drug bedaquiline became effective last July 18.
Bedaquiline is a breakthrough medicine used in TB treatment regimens. It is highly recommended by the World Health Organization (WHO) for being a far-improved, shorter, better-tolerated and more effective cure for people affected by DR-TB.
At present, the suggested treatments, containing bedaquiline, are all taken orally for six months, with as high as 89 percent cure rates. This is a big improvement compared to the older treatments that had to be administered for 18 months and included daily painful injections.
“The secondary patent is already granted in the Philippines,” Sinhye Ha, advocacy adviser for Southeast, East Asia and the Pacific at Doctors Without Borders/Médecins Sans Frontières (MSF), told the BusinessMirror in an email interview.
This island nation is among the 34 of the 49 countries with a high burden of TB, TB-HIV and/or DR-TB, where J&J holds secondary copyright on bedaquiline that forms part of treatment regimens.
“Thus, J&J can enforce their patents already at any time, should the Philippines use generic drugs procured outside GDF [Global Drug Facility],” she added.
The American pharmaceutical company’s deal with the GDF was announced last July 12 to increase the availability of affordable generic bedaquiline to selected low- and middle-income countries (LMICs) with a high burden of people living with TB. The list of which is yet to be disclosed.
TUBERCULOSIS is an infectious disease that mostly affects the lungs due to a type of bacteria. It’s airborne such that other people can possibly contract it when the disease carrier coughs, sneezes or spits. Nevertheless, those infected but not yet ill with the disease cannot transmit it.
According to the WHO, TB is ranked 13th as the main cause of death worldwide, and the second leading infectious killer after Covid-19 (above HIV and AIDS).
In 2021, around 10.6 million people got sick with TB across the globe, and a total of 1.6 million succumbed to it (including 187,000 with HIV).
The Philippines is now No. 4 in terms of the number of TB cases globally, and has the fourth largest number of TB fatalities too, based on the WHO 2022 report.
Prevalence-wise, there were 372,367 TB cases recorded by the Department of Health (DOH) in 2022. It is projected that TB incidence and deaths will increase by 130 percent and 170 percent by 2025, respectively.
Fighting the disease
SINCE time immemorial, the Philippine government has been fighting TB with various initiatives to ease the burden of Filipinos afflicted by this dreaded illness. One of these initiatives is the WHO-approved standardized and effective cure for TB called DOTS (directly-observed treatment, short-course), which has been implemented here since 1996.
The DOTS program makes sure that patients get the correct medications they need to completely cure their disease and infection. The TB DOTS Clinic, which is usually found in community health centers, caters to diagnosed or suspected TB patients, wherein they are given free medications for at least six months.
“Bedaquiline is the cornerstone of DR-TB management, and to our knowledge, it is part of the free DR-TB regimen available in the Philippines,” shared Christophe Perrin, TB advocacy pharmacist of Doctors Without Borders Access Campaign.
Helping the country’s anti-TB effort, Doctors Without Borders, an international emergency medical humanitarian organization, has been working with the Manila Health Department on a TB screening project in Tondo, Manila. The project is focused on screening—actively looking for cases of TB.
“For those found to have TB, we refer them to the Manila health centers for free treatment,” he said.
From May to December 2022, Doctors Without Borders screened 3,282, and diagnosed drug-sensitive TB (DS-TB) in 269 people. Working with the Manila health centers, 189 patients started treatment. Four patients were found to have DR-TB.
For this year, the disease has so far increased. As of June 2023, the group has already screened 7,637, of which 466 were diagnosed with DS-TB. Again in cooperation with the health centers in the capital city, 211 patients began their medication. So far, four patients have been detected with DR-TB.
Cure comes with a price
CONTINUOUSLY highly burdened by this health malady, the Philippines will have to continue to pay high prices for bedaquiline, which he noted as the “backbone of DR-TB treatment,” since J&J’s right on it remains in place locally.
Currently, bedaquiline is priced at $1.50 per day for an adult treatment ($272 for a six-month average treatment period). With scale-up and generic competition, however, it would drop, bringing it closer to the estimated target price of $0.50 each day. When procured through GDF, bedaquiline now costs as low as $45 per person per month, still higher than the target generic price at $8 to $17 for every person a month, should generic drug competition be allowed.
Indian generic companies Macleods and Lupin are now ready to start manufacturing generic bedaquiline since India did not grant secondary patents to J&J. Unfortunately, their entry into the Philippine market would no be possible since a generic manufacturer that exports its version of bedaquiline to or from countries where secondary patents on the drug exist could face the risk of legal action from J&J.
“Macleods and Lupin will not risk being taken to court by infringing the J&J secondary patent wherever it is granted, unless J&J gives them a waiver, like the J&J and GDF deal,” Ha pointed out.
Generic versions such as theirs that are of quality as the J&J’s bedaquiline could be three times cheaper for Filipino DR-TB patients.
“Since our TB project [here] is focused on screening and not treatment, Doctors Without Borders operations are not directly affected by the J&J secondary patent. However this would impact the national TB budget, as the country will have to continue to procure the drug at high prices, unless it procures through GDF to access generic bedaquiline under the deal [with J&J]. The question now: Is the Philippines on the list of this deal?” she warned.
“With funds dedicated to the high prices for bedaquiline, that means less money that the NTP [National Tuberculosis Control Program] can dedicate to other key needed investments in all countries affected by TB, such as outreach campaigns to identify more people affected by DR-TB [only a third are diagnosed and provided a treatment globally], infection control in health facilities, health care worker training, food packages, etc.,” Perrin noted.
Call for patent drop
THE Doctors Without Borders has reiterated its appeal for the US pharmaceutical giant not to enforce any secondary patents for its own version of bedaquiline in any country that suffers the most from TB, as well as withdraw and abandon all of its pending applications for such everywhere in the world.
The nonprofit organization, likewise, called for a commitment from J&J to not sue any generic manufacturer that exports their own versions of bedaquiline to or from TB high-burden countries where its secondary patents on the drug exist. It even asked the company to make this announcement public by the UN TB Summit in New York next month.
“J&J has never showed any interest in making a public statement when they have been challenged on their access strategy on bedaquiline,” Ha revealed. “To our knowledge, they have provided no answer to the first letter sent publicly to J&J by the National TB Programme in Belarus.”
Pressed on what the Philippines needs to do in so far as combatting the looming monopoly over the bedaquiline market here is concerned given the J&J patent issue, she advised the careful licensing of drug manufacturers in the country so as to avoid a repeat of such in the future.
“Not only for bedaquiline but for essential health tools, governments should watch that corporations do not get unmerited patents granted. This is an area that often slips past health authorities because it does not fall under their jurisdiction,” she stressed.