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A mechanism to systematically assess trade agreements from a public health perspective, including accession agreements of the World Trade Organization and European Patent Office’s validation agreements is needed, says Ellen ´t Hoen, senior researcher at the Global Health Unit of the University Medical Centre, Groningen, The Netherlands, who publishes the Medicines Law and Policy website.

She said that such a mechanism would safeguard the measures countries have under the TRIPS (WTO Trade-Related Aspects of Intellectual Property Rights) agreement, to protect and advance human rights.

´t Hoen was speaking at a session of the United Nations Social Forum convened by the Human Rights Council on 4 October in Geneva titled, “Translating principles into action: Access to medicines, diagnosis, vaccines and treatment in the context of the right to health.”

“The reason why we have problems with patents and increasingly with other market exclusivities such as data exclusivities – is because our system of innovation is based on the premise that granting monopolies is the best way to finance innovation,” said ´t Hoen.

Such monopolies will, however, always drive research and development (R&D) efforts into the most profitable areas, and not those of highest needs, leading to high drug prices, she asserted.

“We need to move away from that. If you continue to rely on the system of exclusivities to finance innovation you will always have high drug pricing, rationing of essential meds and growing inequalities and inequities in health,” she said, noting that while TRIPS flexibilities may remedy the latter it does not offer a solution to the deeper problem.

Access Differs from Country to Country

Moderator Susan Mathews, a human rights officer in the Right to Development Section of the UN High Commissioner for Human Rights, started by saying that access to medicines, diagnosis and vaccines affects different countries as well as population groups within countries very differently.

“Simply put, inequality can kill,” said Mathews.

She said that the way pharmaceutical research, development and innovation is currently organised, increased intellectual property protection particularly disadvantages developing countries and poor, vulnerable, marginalised populations within these countries.

“On the supply side, the global pharmaceutical market, now worth approximately US $1 trillion a year, is highly concentrated in Western markets. On the demand side, industry innovates in response to the needs of these concentrated markets,” said Matthews.

She noted that estimates show that developing countries represent approximately 1 percent of global pharmaceutical demand and that their unique needs are generally neglected and do not drive commercial research and development.

This is particularly of concern, said Mathews, for diseases prevalent in the Global South, where product development is not considered commercially viable despite the significant health burden associated with these diseases.

Skewed Supply

“The second factor, which reinforces this skewed and unequal supply and demand is a reliance on patents to reward research with monopoly rents, enforced through trade and investment regimes,” she said.

This leads to the question of how can innovation that does not rely on the patent system be encouraged in order to break or disrupt the link between the costs of research and development and the price of medicines.

Elena Villanueva Olivo, innovation and access policy adviser for Médecins Sans Frontières (MSF), explained how the lack of urgently needed medical tools in the 2014-2015 Ebola crisis in West Africa that claimed more than 11,000 lives was a wake-up call for many reforms. This included how research and development is collectively carried out. She said many millions were spent and the vaccine is now close to approval, but has still not been approved.

“So today, even after the end of the outbreak, we still have no approved drugs, vaccines and diagnostics to address Ebola. And this speaks to the fundamental failure of our current system of R&D – not only to produce affordable drugs and vaccines, but to prioritize and develop them in the first place,” Villanueva said.

Today, she said, there are significant efforts to respond ahead of time and avoid gaps and failures that include a World Health Organization coordination effort known as the WHO Blueprint, and a particular R&D initiative called the Coalition for Epidemic Preparedness Innovations, or CEPI, meant to accelerate the development of pipeline vaccines for these diseases through Phase II trials so that they can be ready for use in the next outbreak.

“While we support both initiatives, we are concerned that the standards to promote access, namely transparency, intellectual property and pricing, are not sufficient, in particular given that nearly all the R&D costs are being paid for by governments and philanthropies,” said Villanueva.

Othoman Mellouk, intellectual property and access to medicines lead for the International Treatment Preparedness Coalition from Morocco, referred to a “dangerous game of haves and have nots” that he said are created by big pharma companies.

As did the preceding speaker, Raquel Peck, CEO of the UK-based World Hepatitis Alliance, Mellouk congratulated the government of Malaysia which recently “translated the principle of access to affordable medicines into action.”

He was referring to Malaysia announcing he first-ever compulsory licence on a treatment for hepatitis C – sofosbuvir – “the famed US$1,000 a pill drug sold by US MNC Gilead Sciences.”

“Today generics for HIV and Hepatitis C are available but not for everyone: Like Malaysia, so-called middle-income countries are routinely excluded from licences and pricing arrangements; the dolutegravir pricing arrangement recently announced by UNAIDS is a case in point,” said Mellouk.

“It is baffling that even with the involvement of UN and other international agencies the potential for affordable dolutegravir excludes key middle-income countries that are seeing an increase in HIV incidence.”

He noted that by 2020, the vast majority of people living with HIV, 87 percent, will be in high- and middle-income countries. And middle-income countries are home to almost half of the world’s population, and have a large and growing share of HIV infections (62 percent), he said.

“They have even lower rates of antiretroviral treatment coverage than low-income countries. One third of people living in middle-income countries survives on less than US$2 per day. Almost 6 million people in middle-income countries (excluding sub-Saharan Africa) need antiretroviral treatment. However, less than a third are currently able to access it,” said Mellouk.

He argued that developed countries are ultimately acting “by and on behalf of big pharma” and that he disagrees with those who believe his group’s actions, advocacy and campaigns should only be directed “at our governments.”

Mellouk said his group will hold governments accountable and advocate and campaign against developed country free trade agreements that threaten global production in the South.

‘Holding Transnational Corporations Accountable’

“An ongoing effort within the UN to draft a framework holding transnational corporations accountable for human rights violations is something that now deserves our attention if we are to ensure that the lives and health of people are no longer held hostage by the profits and PR of a company,” Mellouk stated.

From the floor, Sophie Mautle, minister counsellor at the Botswana Mission in Geneva, said that her country had benefited from philanthropies and was fortunate to have received assistance in the early days of the fight against the HIV epidemic, “which resulted in preventing what would have been a socio-economic catastrophe.”

“It is the result of partnerships such as those established with the Gates Foundation, the United States President’s Emergency Plan for AIDS Relief (PEPFAR), Botswana-Harvard partnership, UNAIDS and many others that we were able to realize the results we have today,” she said.

Mautle explained that the partnerships have been critical in the ability to provide early diagnosis and continued research that allowed provision of the right medication and made significant contribution to reducing mother to child transmission from rates of a high of 40 percent in 2001 to 2 percent.

“We have also witnessed similarly laudable results in the number of deaths from HIV complications from around 14,000 in 2005 to around 3,000 in 2015,” said Mautle.