Will BRICS countries step up to the challenge of finding new TB medicines?

Will BRICS countries step up to the challenge of finding new TB medicines?

Tuberculosis is a classic poor person’s disease – a limited problem in the United States and Western Europe, but killing hundreds of thousands of people every year in countries like India, China, Indonesia, Nigeria and South Africa. As a disease that mainly affects poor people, TB offers limited incentives for the private sector to invest in researching new medicines to treat it. It is a textbook example of how the current patent system fails to incentivise research in diseases that mostly afflict poor people.

A number of large pharmaceutical companies like Pfizer, Novartis and AstraZeneca have stopped investing in the search for new TB drugs altogether. Those who are still in the game spend comparatively little. Otsuka Pharmaceuticals, by far the biggest industry investor in TB research and development (R&D), put only an estimated $53 million into TB R&D in 2014. The pharmaceutical industry body PhRMA (Pharmaceutical Research and Manufacturers of America) claims that their members invested a total of $51.2 billionin R&D in 2014 – less than 0.2 percent of which went to TB – a disease that killed 1.5-million people in the same year.

Is the gap being filled by governments and donors? According to the Treatment Action Group’s annual report on R&D trends, the world spent just $674 million on TB R&D in 2014. This is only a third of the $2 billionper year target set in the Stop TB Partnership’s Global Plan to Stop TB. The report also shows that the vast majority of funds for TB research still come from the United States
There is some hope in the form of initiatives like the National TB Research Strategy for South Africa. We understand that the focus of this initiative is on shorter term operational research – which is extremely important, but just part of what is needed.

Most importantly though, we haven’t seen the massive injection of funds and the coordinated multi-national push that is needed to truly change the game in TB research. We’ve actually seen the opposite with the paltry amounts invested in R&D by high burden countries. The failure of the BRICS countries (Brazil, Russia, India, China, South Africa) plus Indonesia – which have large TB burdens as well as economies – to come up with a truly ambitious TB R&D plan, and to then fully fund that plan, shows a worrying lack of vision and commitment. As it stands, we won’t see large new TB labs being setup in Delhi or Durban – and we won’t see these labs attracting top researchers from across the world to help us look for new TB treatments. We’ll see no more than incremental advances.
The fact is that across the BRICS our people die of TB, but our governments invest peanuts in finding new treatments for it.

One of the underappreciated lessons from the AIDS response is that highly effective medicines with acceptable side effect profiles could make an important impact on disease despite many healthcare system failings. Even now, while the public healthcare system in South Africa is creaking and stumbling from one crisis to another, HIV-positive people do relatively well as long as we get the right antiretrovirals into their hands. With TB medicines we are far from that point, and much less so with MDR-TB. We must, of course, do all we can to strengthen public healthcare systems, but in a context where sustained success in that regard looks increasingly unlikely, much better medicines might well be our best bet in the longer term.

For years, though, the problem was that there was no clear framework with which to move forward regarding TB R&D. It was unclear how much money which countries should give and for what. As activists we could point at the consistent $1.3 billion R&D short-fall, but who could we point to to make it up? Who should be held accountable? Until recently, how to formulate meaningful questions for donors and governments, and then hold them accountable to, was a serious challenge.


An Apollo Project for TB?

Now we finally we have a revolutionary R&D plan on the table. The plan in question is the so-called ‘3P business plan’ – or the Apollo Project for TB as we’re calling it in this article. The countries that should take responsibility for turning the 3P business plan into a fully-funded reality is the BRICS grouping plus Indonesia – since these are countries with both the high TB burdens and the ability to implement such an ambitious project.

The 3P plan is essentially a plan to create new incentives for TB R&D given that it is not sufficiently being incentivised by the patent system (as explained at the beginning of this article). In contrast, the proposed new way would incentivise research through the so-called 3Ps:

Push refers to classic grant funding. Pull refers to prizes to induce and attract. Pooling refers to the pooling of intellectual property to allow medicines to be affordable and accessible once developed.

The most important P is the middle one, Pull funding. It essentially says to companies or research teams that if you develop a compound that meets certain preset criteria we will pay you a lot of money (a prize). The beauty of this arrangement is that the money is only paid if the criteria are met – so even though amounts will be large, we know what we will get for it and there will be little wastage. More importantly though, without such prizes as incentives many compounds would simply remain stuck in limbo, as is currently the case. Finally, the third P means that once new treatments are developed, there will be no patent barriers keeping prices artificially high – since all the R&D would have already been paid for through the prizes.

The project has been costed at between $1.5 billion and $2 billion over a ten-year period. This cost should be weighed up against the substantial cost of: a) not getting the new medicines we need for TB because of a lack of incentives, and b) the high cost of the few patented medicines that we do get through the traditional patent-based R&D system. Either way, there can be no doubt that given sufficient political will, the BRICS countries plus Indonesia can find the money to fund the 3P project.

The outline above is a very brief and oversimplified summary of the 3P plan, but fortunately the idea has already been teased out and mapped out in detail to the extent that it could be implemented quite quickly, potentially starting in January 2017. (To read the full business plan, you can contact Doctors without Borders.)
If there were to be the political will to make a success of the 3P project, the most likely place it could come from is the BRICS countries. The principles behind 3P have made it into a number of World Health Organisation and UNAIDS publications. The WHO has even given the green light to pilot projects testing prize funds similar to those envisaged in 3P. But the conservatism of the United States and Europe has meant that more ambitious plans – like a proposed R&D treaty – have fallen by the wayside. The perceived threat of projects like 3P to the patent system, though unwarranted, means that ultimately the rich northern countries won’t get behind it.

So, here’s an ambitious plan that could truly revolutionise TB R&D. The BRICS plus Indonesia could go ahead with it whether or not there is any interest from the north. It is structured in such a way that any new treatments coming out of the project would be affordable. It could help coordinate TB R&D across BRICS countries and increase research capacity. Most importantly, it would dramatically increase the chances of finding better treatments for a disease that continues to kill hundreds of thousands of people a year.

Unlike any other proposals on the table, the 3P project holds the promise of being a true game changer in our TB response. The only question is whether the BRICS are up to the challenge to launch an Apollo Project for TB.