People living with HIV in Burma are worried that a patent law under development could significantly hinder their ability to access affordable medicine, in a country where about 40 percent of those requiring HIV treatment are already unable to get it.
Facing pressure from Western nations looking to invest in the country as it transitions from military rule, Burma’s government is developing intellectual property laws to replace legislation that dates back to the colonial era. The laws would help protect against counterfeiting, but they would also introduce a patent system for medicine that could significantly drive up prices.
Myo Thant Aung, chairman of the Myanmar Positive Group, an advocacy network for people living with HIV, says the network will meet with members of Parliament next Thursday to brief them on how a new patent law could hinder access to affordable treatment.
“We will tell them, ‘A patent law will really affect us, so please be patient’,” he told The Irrawaddy this week at an annual forum in Rangoon for people living with HIV. About 250 HIV-positive people attended, including those from some of the most marginalized populations, such as sex workers and drug users, along with speakers from UNAIDS, the World Health Organization and other local and international NGOs.
The issue of patents is crucial in the health care sector, especially in developing countries such as Burma that cannot afford costly brand-name drugs. Patents allow pharmaceutical companies to have a monopoly on the production of a drug they invented, in a bid to promote innovation, for the course of the patent term, defined by the World Trade Organization (WTO) as at least 20 years. A patent prevents other companies from producing, selling or importing more affordable generic versions of a drug.
The biggest supplier of HIV medicine in Burma, Médecins Sans Frontières (MSF), sources about 80 percent of its drugs from generic markets. The humanitarian organization, which provides half of Burma’s HIV medicine, says that if it were not able to import generic drugs, the cost for patients would significantly increase and it would not be able to treat as many people as it does.
“The reason that MSF is able to treat so many people with HIV in Myanmar [Burma] is simply that the drugs used are generic versions and are therefore affordable,” said Paul Cawthorne, a coordinator for the MSF Access Campaign, an offshoot advocacy group that promotes access to medicine.
Generic competition over the years has led to a massive price reduction in antiretroviral drugs, a combination of which are used for antiretroviral therapy (ART). The price of ART has decreased from US$10,000 per patient per year a decade ago when MSF first started treating HIV in Burma, to $100 per patient per year now.
All medicines need to be registered before they can be used in a country. Currently in Burma, a generic version of any medicine can be registered and used. If Burma introduces a patent law for pharmaceuticals, all medicines currently in use would continue to be available, but if a new medicine came into the country and was patented, no other company could register a generic version. If only the originator brand-name drug is currently available, a patent law could prevent the registration of a generic version in the future.
“Our concern for the future is that if Myanmar introduces patents on medicines, which it is currently under no obligation to do, it will close the door on the use of new generic medicines that will become available. In the future, new more effective medicines may then be priced at unaffordable levels, not only for the general population, but also for organizations such as MSF,” Cawthorne said. “This issue goes beyond HIV medicines—it includes a future threat to affordable medicines for diseases such as malaria, TB, heart disease, cancers and diabetes.”
Burma has one of the highest HIV prevalence rates in Asia, and a lack of funding for medicine already requires health care providers to regularly turn away HIV patients. Of about 200,000 HIV-positive people in the country, at the end of last year only about 40 percent of those who required ART were receiving it, according to MSF.
At Odds Over Medicine
Developed countries have long been at odds with the developing world over the pricing of medicine. Brand-name pharmaceutical companies in Western countries say they need patents to ensure they make enough profit to continue developing and producing innovative medicines, while poorer countries say they cannot provide treatment without cheaper generic medicines.
Internationally, a major agreement by the WTO sets standards for protecting and enforcing intellectual property rights, including through patents. Known as the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), it came into effect in 1995.
The agreement meant the introduction of patents in some countries, but to maximize access to life-saving drugs, a group of least-developed countries —including Burma—were given a transition period to comply. The deadline for compliance was extended this year, from 2016 to 2021.
Some least-developed countries have used the extra time to develop legislation that allows for flexibility with patents, and to manufacture HIV-related medicines. India waited until 2005, later than some other developing countries, and as a result, drugs produced by its generic companies are among the cheapest quality-assured medicines in the world. Because of these affordable medicines, India—which borders Burma—is now known as the pharmacy of the developing world. Eighty percent of HIV medicines used by MSF are sourced from Indian generic drug companies.
In contrast, South Africa, with one of the world’s highest HIV infection rates, complied with TRIPS earlier but did not insert certain flexibilities into its patent legislation, leading to the issuance of far more patents than in some other developing countries.
Investors Push in Burma
Despite the 2021 deadline to comply with TRIPS, new intellectual property laws in Burma could be introduced later this year, legal experts say, in a bid to boost the economy by wooing foreign investors.
“Lack of specific intellectual property laws and reliable enforcement are major concerns for foreign investors, especially the ones in science and technology businesses,” said Nikolas Tun of Kelvin Chia Yangon, the oldest foreign legal consultancy firm based in Rangoon, which works with international businesses.
He said Burma planned to pass intellectual property laws by later this year or early next year.
“The Myanmar government is in its 11th draft of the intellectual property laws right now, which is expected to be the final version for submission to the parliament for legislative discussions and approval, and is keen to move forward as fast as possible to enact them,” he told The Irrawaddy.
The draft Patent Law was developed in coordination with the World Intellectual Property Organization, he said, in line with TRIPS as well as international standards and norms, to ensure easy accessibility of patients to life saving drugs, such as ART.
The draft law could include provisions allowing the government to override patent rights for drugs deemed important enough for the country’s well-being, by granting a license that allows someone else to produce the patented product without the consent of the patent owner.
Use of these licenses, known as compulsory licenses, is one of the flexibilities of patent protection included in TRIPS. The licenses could help ensure access to generic drugs but would likely meet with resistance from Western pharmaceutical companies, which would lose their monopoly on production—and the profit that comes with it.
Western countries in the past have tried to employ carrot-and-stick measures to convince developing countries to adopt more stringent protections for intellectual property rights, including by promoting trade agreements with clauses that undermine flexibilities for patent protections.
“It is difficult to know exactly what pressure is being placed on the Myanmar government to adopt IPR that goes beyond what is legally required by the WTO,” said Cawthorne of the MSF Access Campaign, adding that he had not seen the draft law. “We do know that the World Intellectual Property Office is offering technical assistance to Myanmar, and that such technical assistance in other countries as been somewhat skewed toward higher-than-necessary IPR standards. We also know that both the US and EU have been ‘offering advice’ to Myanmar, but we can only guess at what this advice is.”
He urged the Burma government to seriously consider not including medicines, vaccines or medical devices in its new law, as he said this would not be required under WTO regulations.
“If the government wishes to proceed with including these items in the new law, they should ensure that as broad a range of flexibilities are included to avoid the direst of consequences on access to medicines,” he said. “The India patent law is perhaps the best example in the world of a patent law that is compliant with WTO TRIPS regulations yet maintains all TRIPS flexibilities and a very strict interpretation of what is patentable and what is not.”
Loon Gangte, a leader of the Delhi Network of Positive People, an India-based advocacy group for HIV patients, urged Burma to wait as long as possible to become TRIPS compliant.
“The main barrier to access to treatment is TRIPS and bilateral agreements between countries,” said the activist, who was diagnosed with HIV in 1997 and traveled to Rangoon this week for the forum. “Other countries are pressuring Myanmar [Burma] to make its laws comply with TRIPS earlier. But look at South Africa. By waiting until 2005, India inserted more flexibility, and as a result, India has one of the world’s best patent laws.”
He cautioned against signing trade agreements with Western countries that could limit flexibilities on patents. “Myanmar is up-and-coming,” he added, “and no country can sustain itself alone. We need to work with other countries, fine. Let’s trade everything—let’s trade cigarettes and jeans. Imported cars, no problem. But don’t trade your life or my life.”
‘The Only Thing That Can Stop It’
Even without patents, HIV patients in Burma face barriers to treatment, as the country struggles to reform its health care system, which was chronically neglected by the military regime and continues to be hampered by budget constraints.
Health care providers say they do not have the capacity to follow global guidelines on when to begin treatment for HIV, with low funding forcing them to routinely need to turn away patients. Clinics offering HIV medicine can only take the sickest people, usually at a stage in the disease that puts them close to death.
Until recently, one of the biggest challenges to scaling up treatment was a lack of international financial support, especially after the Global Fund to Fight AIDS, Tuberculosis and Malaria suspended its grants to Burma under the former junta, citing political interference in its programs. The Fund returned to the country two years ago, pledging to provide $161 million through 2016 for HIV activities.
Dr. Khin Nyein Chan, medical coordinator for MSF in Burma, said the additional funding would allow about 85 percent of patients in need of ART to receive treatment based on national enrollment criteria.
“The big challenge now is whether there is the overall capacity within the health care sector in Myanmar, and particularly within the Ministry of Health, to start enrolling increased numbers of patients,” he said. “Increased human resources and expertise on HIV care and treatment is necessary, especially outside the main centers, as only a decentralized treatment model will be able to reach most patients.
Zarni, another HIV-positive patient in Rangoon, was unable to access treatment in his hometown in Magway Division. “ART is only available in the big cities,” he told The Irrawaddy. He came to the commercial capital for treatment and now works for MSF. “We need more ART.”
Loon Gangte from India agreed. “We all have HIV,” he said, referring to a crowded room at the HIV forum this week. “HIV is not sitting idle—it is always working, 24 hours a day, seven days a week. Nothing in the world can stop it—better nutrition can’t stop it, religion can’t stop it. The only thing that can stop it is ART. In order to live, nothing is more important than ART.”
Source: THE IRRAWADDY