At WTO, experts discuss solutions to drugs innovation crisis; IP not in the list

The WTO Public Forum is taking place from 1-3 October (IPW, WTO, 2 October 2014).

Anthony So, director of the Program on Global Health and Technology Access at the Duke University Sanford School of Public Policy, said research and development (R&D) productivity in the pharmaceutical sector has been declining, despite growing inputs.

At the same time, he said, prices of new drugs have been “alarmingly” rising. He illustrated the fact by saying that 11 of the 12 cancer drugs approved in 2012 were priced over US$100,000 per patient per year. According to So, among the top 100 drugs in the US, “the median revenue per patient rose from US$1,258 in 2010 to US$9,396 in 2014.”

Publicly-funded research institutions have long been a large contributor to innovative drugs, he said, for example to “virtually all the important innovative vaccines” that have been introduced over the past 25 years.

On the lack of availability of “priority patents,” he said that some years ago the Malaria Vaccine Initiative had a project to pull together key patents to bring a new malaria vaccine to market. The patent landscape for malaria showed 167 patent families, held by 75 different organisations. Although the Initiative narrowed its search to 39 priority patents, by the time the patent landscape was conducted, nearly half of those priority patents were no longer available for licensing, he said. Many of these patents, he added, were originally held by publicly-funded research organisations.

De-linking the cost of R&D and the price of health products is a key concept, said So. Ways of making de-linkage possible include pull mechanisms, such as advance purchase commitments and prizes. Push mechanisms, such as research grants, might also be used so that universities play a strategic role in de-linkage, he said.

Robert Don, discovery and preclinical director for the Drugs for Neglected Diseases initiative (DNDi), said the organisation was created in 2003, and in the following 10 years delivered six new treatments, and is planning to deliver 11 to 13 more by 2018.

DNDi’s founding partners include MSF, the Indian Council for Medical Research, Kenya Medical Research Institute, and the Oswaldo Cruz Foundation in Brazil.

Don presented the case of ASAQ (he put it in caps in slide) a fixed dose combination of artesunate and amodiaquine for treating malaria. The drug was developed by DNDi with public funds, and the non-patented product was licensed to Sanofi, after the World Health Organization prequalification in 2008 (IPW, Public Health, 14 April 2008).

Government Perspective

Marcela Paiva Veliz, counsellor at the Permanent Mission of Chile, said from a practical health perspective, a number of different stakeholders are important in the process, such as the private sector, universities, patients, and civil society.

Completely dissociating R&D and prices might be difficult at this stage in terms of public policy, she said, but Chile is ready to explore this matter further. Access to essential medicines is “more or less covered” through public and private funding in Chile, she said.

On the international scene, the delegate underlined two initiatives: the Medicines Patent Pool, which she said was an interesting new initiative, supported by Chile which was looking forward to MPP moving to other diseases. The MPP currently covers HIV AIDS medicines.

She also cited the PAHO (Pan American Health Organization) Revolving Fund for Vaccine Procurement. She underlined the necessity to have a balanced approach to international regulation and the use of trade flexibilities.

Current IP Paradigm Obstructs Scientific Progress Says UAEM

Lukas Fendel, executive director of UAEM Europe, said UAEM is a group of international students, young researchers, and emerging global health leaders who believe that universities are “uniquely positioned to make a difference in the global R&D crisis.”

“We are currently stuck with an innovation infrastructure that attempts to incentivise R&D mainly by granting IP rights,” he said, which results in an innovation crisis. “There is a misalignment of R&D with the actual health needs of big populations,” he added, particularly relevant to neglected diseases.

The innovation issue runs parallel to the access issue, said Fendel. Drugs are priced out of reach for the population of low and middle-income countries for infectious diseases but also chronic diseases.

“IP-centred innovation eco-systems obstruct scientific progress and innovation,” according to Fendel. The patent landscape gets ever more complex and expensive to navigate, which leads to duplication of efforts among scientists, researchers, industry and the public sector, and results in corporate secrecy, strategic patenting and patent thickets.

University and public research institutions are well positioned to address the access and innovation crisis, he said, as they are “truly innovation hubs” and have a mission to promote public welfare through creation and dissemination of knowledge. They “should strive to establish a new campus drug culture, and should be active stewards of knowledge creation and dissemination in the public interest,” he said. In particular, this should be through the creation of internal policies for global access licensing and other socially responsible licensing mechanisms.

Universities should also “fervently” support open source drug discovery mechanisms, he said, and take part in existing ones. They “should teach critical approaches in economics rather than indoctrinate students with the neo-liberal consensus on how IP should be managed and treated.”

During the Q&A session, So remarked that universities sometimes hold fast to their IP “as the last piece of gold” due to the “lottery ticket” effect created by the current innovation system. Some 30 years after the Bayh-Dole Act, he said, less than 5 percent of research revenue comes from licensing revenues in the United States, he said.

Open Source Dividend as a Solution

James Love, director of Knowledge Ecology International, advocated openness in upstream research. Society does not reward the sharing of information, he said, and provides incentives through patents and trade secret to make research closed.

An open source dividend is a proposal to fix that problem, said Love. He explained that companies selling registered drugs would have to set aside a small percentage of the sale price into a fund to pay for the open source dividend.

Taking as example a drug from Roche with sales of US$500 million per month, one percent of the sales would represent US$ 60 million a year.

Then when a product is put into the market, a jury of experts would be appointed to examine evidence determining what type of research was used by the company to develop this product, such as academic papers, databases and open libraries.

The impact would be a new financial incentive to open source medical research and would encourage third party use, allowing greater access to knowledge data, materials and technology. There would be fewer patent thickets, and it would be less expensive to acquire rights to use knowledge data, materials and technology, Love said.

Other solutions include expanding access to government funded research, and placing research paper in open archives, he said.

Source: Intellectual Property Watch