I-MAK

Continuing the previous post on this topic, the report of the All-Party Parliamentary Group (APPG) on Aids called 'The Treatment Timebomb' was released yesterday. A copy can be downloaded here.

The key messages from the Report were highlighted in the Guardian article, but some other interesting highlights are:

• The idea of creating a patent pool is to mimic the situation in India before the new product patent regime kicked in.
• GSK in its written evidence to the APPG believes that HIV is not a neglected disease and to improve access they have given out extensive voluntary licenses (including the royalty free license to the South African company Aspen to produce abacavir, which was coincidently announced yesterday - see report here). As a result GSK does not see the need for patent pools on HIV medicines.
• The Report also encourages the Gilead model of voluntary licensing of tenofovir to 11 Indian companies - but recognises that despite voluntary licenses being in place for several years there are still signiifcant research gaps.
• Patents are an important incentive for R&D, but do not drive investment into HIV medicines specifically needed by developing countries. Indeed, patents can sometimes hinder such research.
• WIPO should be held accountable for the new development agenda and asked to demonstrate examples of how it is supporting developing countries implement TRIPS flexibilities.
• The UK government should use its influence within the EC to halt TRIPS plus trade agreements that are currently being negotiated, as well as pushing for a reviews of the EC custom regulations that have recently allowed originator companies to seize generic medicines in transit to countries where there are no patents in force on the product or under the guise of counterfeiting.
• Most fixed-dose combinations (FDC) of ARVs come from the generic sector in response to market demand and not patent incentives.
• Patents can create barriers to new FDC's given the cost and complexity with three different patent holders. Also, overly broad rights result in patent thickets.
• Patent pools have the advantage of creating much larger fields of competition, coming close to a free market, whilst preserving benefits for originator markets.
• Generic competition has been central in reducing the price of ARVs.
• Any investment in anti-retroviral treatments should go hand in hand with investment in common serious co-infections or opportunistic infectons, such as turberculosis and hepatitis-C, which are usually responsible for most of the deaths of people living with HIV/Aids.
• Where the generic purchase of 2nd-line ARVs is not possible because of patents, prices can be upto 17 times the price of first line drugs.
• It took political activism almost a decade ago to make life saving medicines available to the poor. Political activism is needed once more to ensure the next generation of drugs is available to the world's poorest in the future.

A few comments/thoughts on some of the points above:

GSK's comments on voluntary licensing and the lauding of Gilead's licenses to Indian generics needs to be put in context.

I wrote a research piece for Oxfam in 2007 on the role of voluntary licenses, available here. One of the things I noticed during the research was that a number of the companies that took licenses never actually brought any product to market. Indeed, as of April 2008 (almost two years after the licenses were entered into), only 1 of the 11 licensees for tenofovir had a product on the market, with a possible two more companies that were almost ready to launch at that time. The fact that Gilead claimed to have given a royalty free technology transfer was misleading as many of the generic companies that had entered into the license told us that the technology transfer was nothing more than what was publicly available in the patent specification. To read an analysis of Gilead's example licence agreement, see here.

Therefore, for GSK to claim that voluntary licenses take care of the HIV market needs or that the Gilead model should be encouraged is a tad misleading without looking at the full picture. For voluntary licensing to work more transparency and regulation around such licenses needs to happen.

With respect to patent pools, while they offer a possible solution, a number of questions remain on how the system will work.

For example, one wonders whether companies will be willing to give the crown jewels in their ARV patent portfolios to the pool e.g. Abbott and ritonavir? Will companies pool patents for opportunistic infections like hepatitis-c as recommended in the Report? Who will ensure that the pooled patents are merited patents so as to prevent originator companies earning rent where there should be none? What will the patentability standard be? Will the patent pool system detract from developing countries using TRIPS flexibilities - such as implementing tougher standards of patentability? What will the royalty rates be? If royalty rates are too high that generic companies won't cooperate, we could end up in a blame game and stalemate.

In sum, there's nothing particularly new coming out of this report that those involved in the debate didn't already know or haven't been saying for the past 4-5 years. To say that political activism is needed once more to ensure the next generation of drugs is available to the worlds poor does a bit of a disservice to those that have continued to work on these issues for the past 5-10 years. If it takes a single government body  this long to validate the ongoing problems with the patent system and access to medicines, one wonders how long it will take other governments. Still, it is good to see a developed country government body make inquiries and bring attention to the problems of access to ARVs and related illnesess.

On a separate but related note, for those of you who are not familiar with patent pools, the StopAIDSCampaign have launched this very useful animation explaining how they work:

According to a story in yesterday's Guardian newspaper, the All-Party Parliamentary Group On Aids is set to release its report this week detailing the need for pharmaceutical companies to pool their patents on HIV medicines to counter the "treatment timebomb".

The parliamentary group's report is said to indicate that by 2030, 50 million people will need new HIV drugs, which are currently too expensive, to keep them alive. The report also highlights that only a third of those in need of medicines are receiving treatment, but going forward there is a need to ensure access to the next generation of drugs. By suggesting companies holding patents on HIV drugs pool them for the international drug purchasing facility Unitaid - generic companies will be able to make lower cost versions and new combinations in a single pill of the new generation of treatments.

It will be interesting to see whether GSK and others who have agreed to pool patents on some neglected diseases, but not HIV drugs, for least developed countries will make a u-turn?

Will Abbott Laboratories and Bristol Myers Squibb (BMS)/Novartis be willing to pool their respective patents on the second line drugs ritonavir and atazanavir to allow for a fixed-dose combination of the two - which according to reports here and here, is believed to be considerably cheaper to produce and has similar antiviral efficacy to Abbott's ritonavir/lopinavir (Kaletra) combination. To do so would mean Abbott losing  market share and profits from Kaletra - something that Abbott has aggressively avoided by hiking up the price of ritonavir by 400% to avoid competition from other companies protease inhibitor compounds, notably atazanavir (see Wall Street Journal report).