Drug Access Issues In Spotlight At UN High-Level Meeting On HIV, WIPO Event

This week the United Nations meets in New York with the possibility of finding a way to end the HIV crisis that in the past two decades spread like wildfire and disrupted societies in many developing countries, in particular in sub-Saharan Africa.

[Update: Intellectual Property Watch has obtained a copy of the Assembly declaration text, here. The intellectual property rights section is found on page 11.]

The UN General Assembly High-Level Meeting on AIDS, which runs from 8-10 June, will “provide an opportunity to take stock of the progress and challenges of the last 30 years and shape the future AIDS response,” according to the conference website.

“We have reached a critical moment in time,” General Assembly President Joseph Deiss said today at the start of the UN meeting, which brings together some 30 heads of State and government, along with senior officials, representatives of international organizations, civil society and people living with HIV.

“This high-level meeting is a unique opportunity to reiterate our collective commitment and to step up our campaign against AIDS,” he said.

The UN said member states are expected to adopt a “new declaration at the end of the three-day meeting that will reaffirm current commitments and commit to actions which will shape the future of the AIDS response 30 years into the epidemic and 10 years since the Assembly’s Special Session on HIV/AIDS in 2001.”

Achieving universal access to needed HIV treatment is a goal that is within reach, argue advocates for people living with HIV gathering for the High-Level Meeting. The availability of affordable, appropriate medicines is critical to this goal, especially in light of recent evidence that treatment reduces transmission rates by 96 percent.

But the current intellectual property system is not currently delivering such medicines in the poorer markets where it is needed most, some say.

Today, a rally was being held in New York urging leaders to take action to end the crisis, led by Médicins sans Frontières (MSF, Doctors without Borders).

On the sidelines of the recent World Intellectual Property Organization Standing Committee on the Law of Patents (SCP), which took place 16-20 May, a new group – the Medicines Patent Pool – presented its proposed solution to the need for these medicines. The Pool is also expected to be discussed this week at the High-Level Meeting, as Thursday’s events focus on innovation to stop the HIV treatment crisis.

The Medicines Patent Pool will hold an event tomorrow entitled, Market Interventions for Innovations and Access [pdf].

The Medicines Patent Pool is a new mechanism that works within the intellectual property system to increase access to cheaper medicines for the people who most need them, the group says.

“You either find a way to get cheap treatment for HIV, or you’re going to have millions and millions of dead people,” said James Love, director of advocacy group Knowledge Ecology International, speaking at the SCP side event.

If nothing is done to increase access to and innovation for developing country markets, the world risks “creating a market that only reaches the rich,” and poor people who need medicines “either go bankrupt or they die, and probably both,” said Hans Hogerzeil, the outgoing director of Essential Medicines and Pharmaceutical Policies at the World Health Organization.

“Ethically, from a public health point of view, it is simply not justifiable that medicines exist [but] are only there for the rich,” he added. Patents and health was on the agenda of the 16-20 May SCP for the first time (IPW, WIPO, 19 May 2011).

The Medicines Patent Pool is a new initiative that grew out of innovative financing mechanism UNITAID in July of last year (IPW, Public Health, 8 June 2010), in response to concerns about increasing prices on needed medicines due to changing intellectual property regimes, especially in countries such as India, where the majority of the low-cost drugs available in the developing world are made.

“We have made enormous amounts of progress in the last decade. Six million people have access to antiretroviral medicines without which they would die,” said Ellen ’t Hoen, executive director of the Medicines Patent Pool. But “there are a further 10 million that do not have access.”

That number is expected to grow to about 20 million people by 2025, many of whom will need specially adapted treatments – such as formulations appropriate for children – that are not now being developed in spite of the need, ’t Hoen said.

Many newer antiretroviral treatments will not be off patent for over a decade, ’t Hoen said, and with current needs “we don’t have that time to wait.”

The Medicines Patent Pool aims to get around potential patent barriers by creating a “pool” of HIV-related intellectual property negotiated from different patent holders of needed medicines. Once these licences are secured, generic manufacturers can dip into the pool, sub-licensing out the intellectual property they need in order produce a generic version of a particular drug or to conduct research on new versions of the medicines, such as medicines suited for children or simplified, combined treatments that make it easier for people to adhere to treatment in poor settings.

HIV in Children “A Neglected Disease”

Both paediatric formulas and simplified (“fixed dose combination”) treatments are not currently being developed because the market for them is largely in poorer countries that cannot support the kind of monopoly pricing that usually compensates the R&D efforts of the biggest pharmaceutical companies.

“Paediatric HIV has become a neglected disease,” said ’t Hoen. Further, “today there is not a single WHO-recommended fixed-dose combination in which all the patents are owned by one company, so if you want to make one of them you will have to bring the IP together to make that happen.”

Fixed-dose combinations are important as HIV treatment regimens are often extremely complicated. If someone has to take 16 pills a day, explained Hogerzeil, it is much harder for them to adhere to that regimen than if they must take only one or two.

Easier access to needed IP rights, argue the Pool and its supporters, make it easier for product development partnerships and developing-country based generics – to whom those markets are appealing – to do the needed work.

Will Pharma Jump In?

Though some patent holders were initially wary, companies seem to be coming around. The Pool now lists itself as “in negotiations” with 5 patent holders of HIV medicines.

This may be due to the mounting public support for the organisation from high-level political bodies. In May, the Patent Pool became an official part of the World Health Organization’s HIV/AIDS Strategy for 2011-2015, and was endorsed by name in the G8’s Deauville Declaration (IPW, Patent Policy, 27 May 2011).

“We hope to see that more and more patent holders will be cooperating with this foundation,” which is “part of WHO’s mandate,” from the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property [pdf], Zafar Mirza, WHO coordinator of the WHO Department of Public Health, Innovation and Intellectual Property, said at the event.

Support also came from national governments during the WIPO side event, though their positions on IP varied.

The Pool is “a very welcome solution… not a complete solution but playing a part” and “though it will not change everything that is not symmetrical in intellectual property in the world, this is a step in that direction,” said the Shree Baboo Chekitan Servansing, the ambassador of Mauritius, representing the African Union.

“Very soon high drug prices will no longer keep medicines from people who need them most in our countries.” the ambassador added.

The United States, which has been very supportive of the Patent Pool, emphasised the importance of the mechanism operating within the current IP framework and added that the Pool’s “voluntary nature does not pose a threat to anyone’s IP, essential to provide incentives.”

And procurement agencies seem grateful as well for legal certainty in the medicines they purchase. Delays in access to life-saving medicines are a serious problem and sometimes groups like the Global Fund, said Sophie Logez, who manages the Quality Assurance and Data Management Team at the drug purchasing mechanism. IP uncertainty can lead to procurement groups having “to take emergency decisions to avoid disruption” of treatment, which in turn affect a country’s capacity to procure improved formulations, such as adapted medicines for children or fixed-dose combinations, she said.

The desire to avoid bad publicity may also be at work. Johnson & Johnson was a recent target of such publicity after a group of bikini-clad students showed up outside pharmacies in the United Kingdom calling for the company to “jump into the Pool” if they really wanted there to be “no more tears” among children with HIV (a play on a J&J’s tagline for its children’s shampoo). MSF added a press release accusing the company of “turning its back on AIDS patients.” Johnson & Johnson still is not in official negotiations with the Pool though has said in public that it is talking to the group.