WHA 68: Experts discuss delinking drug R&D costs from pricing to make them affordable

The World Health Assembly is taking place from 18-26 May.

A 20 May event held at UNAIDS looked at the model used by the research-based pharmaceutical industry to recover R&D costs by charging high prices for the resulting medicines by utilising patents on them. But in recent months and years, prices have hit a point where there is more pushback from consumers and policymakers.

Some are looking into ways to delink the R&D investment from pricing by finding other ways to finance the R&D in a way that does not make the drugs inaccessible to so many people.

On the panel, James Love, president of Knowledge Ecology International (KEI), said there are different types of delinkage models, and there is interest in feasibility studies on the issue. He suggested studies should ask how much is spent under current system, and how much of the revenue will be reinvested in R&D (for instance, if consumers spend $1000 per pill for a hepatitis C medicine, which is currently the price in the United States, how much will they getting back).

The studies also should ask how much money is needed to bring about the desired level of R&D spending, how access and health outcomes would compare under delinkage and the current system, how innovation outcomes would be different, how much the delinkage system would cost, and where the money will come from, he said.

It would be best if the government does the studies so they will be taken most seriously. Their prediction is that a comparison will show delinkage is a better approach.

New Diagnostics Platform

Francis Moussy of the World Health Organization Essential Medicines and Health Products Department, Health Systems and Innovation Cluster, said “the good news” is that there are many new diagnostics being developed. But, he said, LMICs (lower middle income countries) will further struggle to procure and maintain all the different diagnostic tools needed.

He gave two examples of practical steps for facilitating development of needed point-of-care diagnostics. The first is diagnostic interoperability standards and new business models for multipurpose diagnostic platforms for LMICs. The second is a £10 million Longitude Prize for antimicrobial resistance (AMR) diagnostics.

We propose a new approach for diagnostics in local healthcare centres in LMICs, which need to be able to obtain new diagnostics being developed to overcome problems in the field such as no electricity, refrigeration or trained medical staff.

WHO has proposed a “low-cost, robust and open” point-of-care diagnostics platform, he said. It will combine all the various diagnostics that are potentially available to health centres wirelessly on a reader/transmitter with cartridges for multiple diseases and health conditions.

WHO organising a global consultation on diagnostic interoperability standards on 11-12 June in Geneva, as the first step toward the development of the new platform, Moussy said.

He said proposed further work is, in July, to create a working group to identify each interoperability standard needed, create a working group to consider new business models for developing and implementing the new diagnostic platforms, and create a consortium including diagnostic companies and other stakeholders to develop the new diagnostic platforms.

On the Longitude Prize, he said in 1714 a successful contest was held to measure longitude at sea. In 2014, the public voted for resistance to antibiotics as a new prize challenge. To win you must develop a point-of-care diagnostic test that identifies whether antibiotics needed, and which ones if so. It must be needed, accurate, affordable, rapid, easy to use, scalable and other criteria.

The prize has a 5-year timeline. The winner will be awarded £8million, with £2million to help with development of the diagnostics. The winner can be declared any time up to 2019. Entries are assessed every 4 months. So far there are 60 competing teams, from every continent, for the first entry deadline of 31 May.

A representative of Drugs for Neglected Diseases initiative (DNDi) said the group has developed several new treatments but faces a number of challenges for providing sustainable R&D. These include: intellectual property and open innovation platforms, overcoming regulatory barriers, sustainable financing and new incentives for R&D.

She said DNDi tries to delinking the costs of R&D from price of products by setting a maximum price based on what patients can afford through contractual commitments. DNDi is not financed by intellectual property revenue, and enters into no partnerships without overcoming IP barriers. And example is ASAQ, which was not patented.

TDR’s Pooled Fund

Another speaker was Robert Terry, manager for knowledge management at TDR, the Special Programme for Research and Training in Tropical Diseases, a collaboration hosted by WHO, which it sponsors it along with UNICEF, the UN Development Programme, and the World Bank.

Terry gave some history of TDR’s involvement in delinkage and pooled funds for neglected disease research. He discussed areas of work now, such as the Global R&D Observatory established last year by WHO member states. For that, he said, “We still need to understand who’s funding what where and how.”

TDR also is looking at financing R&D in different ways. TDR was given the task of developing a pooled fund, which it is now working on. Terry said he thinks prizes are an excellent approach, but may have some difficulties.

The group is looking at the business plan for implementing the pooled fund, considering options with different amounts, such as $10 million, $50 million, or $100 million. They are looking back at old papers previously developed, he said.

The group also has been commissioned to do a study on new ideas for putting forward products, managing conflict of interest.

He said there is no one place to see everything that’s out there. They will map where the priorities are to be worked on. He noted that he spoke at an event organised by the World Intellectual Property Organization. Terry also made the remark that “We hear about market failure but don’t hear about public sector failure.”

He highlighted new funds coming in from countries like Brazil, India, South Africa, and possibly China.

MSF 3P Project for TB

Katy Athersuch of Médecins Sans Frontières (MSF, Doctors without Borders), talked about the public health group’s 3P Project against tuberculosis.

The 3P (Pull Pool Push) Project aims at developing “affordable, effective new drug regimens to treat tuberculosis, an ancient disease that still kills 1.5 million people a year,” according to MSF’s 3P Project website.

New treatments are urgently needed, particularly for drug-resistant forms of the disease, MSF says. Current drug regimens are “lengthy, toxic, expensive and only about 50% effective.”

The 3P Project “uses an open collaborative approach to conduct drug research and development (R&D), and uses novel approaches to finance and coordinate the process,” it says.

Athersuch said “Pull Pool Push” works like this: They pull in new developer, stock up the pipeline, then pool compounds so anyone in the pool can use them. Then they have to wait for each drug to work its way through the pipeline. And then they push through the most promising, test combinations.

Under this approach, sales price is delinked from cost of developing the drug, she said, adding that this “will transform way we develop drugs.”

Annual global research funding for TB is not meeting goals, Athersuch said. What the health community is “would really love to see” is a combination treatment that would work for everyone, without the severe side effects.

For tuberculosis, there needs to be new R&D, and new ways to re-engage with investors, she said.

Wouter Deelder, a consultant with Dalberg in Geneva, said there is a “very sparse pipeline”, with severe gaps, and that companies lack incentives. The TB market might be a good way to look at some of these other diseases, he said.

A plan might accommodate new actors, design a pool, offer a prize relatively early in the pipeline, hand off those compounds where available for developers, then finance it by push funding, he said. MSF is trying to build coalition to move this forward, make it a test case, he added.

In questions and answers, health foundation PATH raised a question of how to deal with regulatory barriers.

Peter Beyer of the WHO said the MSF TB model is interesting, and noted that at this World Health Assembly there is an antimicrobial resistance action plan. He asked who would own the molecules. He also said he would be interested to work on WHO side on this.

An MSF representative in the audience said the group does not equate this effort with deregulation. The question, he said, is more how do we strengthen regulation at country level.

Event moderator Martin Khor of the intergovernmental South Centre said there might be a need for a global fund for R&D. He closed with a challenge to WHO: “You are the leader of the global health community, whether we like it or not, so please come up with solutions.”

Source: Intellectual Property Watch