HIV Treatment: Low and Middle- income Countries

Jim Sheridan Excerpts

Wednesday 11th March 2015 Westminster Hall

[Pamela Nash]

I thank the hon. Gentleman for that intervention. He is an active member of the all-party group, and I appreciate his support in the work that we do.

I want to move on to the barriers to accessing treatment, which we have drawn attention to in our report. Various barriers were obvious to us at the beginning of our inquiry, but the impact of many came as a surprise. Barriers include the continued high cost of second and third-line treatments. The cost of first-line treatments has come down considerably, particularly due to the fantastic impact of the medicines patent pool. Indeed, the full impact that that will have is yet to come to fruition. However, second and third-line treatments remain very expensive for the poorest people living with HIV.

In our inquiry, we also found that there is completely inadequate access to the most effective testing and diagnostic tools, especially viral load testing. We found that continued weak and unsupported health systems in low and middle-income countries were having a direct impact on people living with HIV. Poor supply chain management is having an impact, although it is avoidable with technical support. Lack of investment in research and development is still having an impact. We found that particularly in lower priority areas and in less profitable treatment areas such as paediatric medicines.

In many countries there is still no political prioritisation of key populations most at risk, unlike here in the UK with our development work. We still see men who have sex with men, sex workers, injecting drug users and transgender people not getting the prioritisation that they need. They are being left behind, even in countries that are otherwise doing well in creating access to medicine. We also continue to see severe stigma and discrimination with respect to all people who live with HIV. That stops people accessing not only treatment, but advice on prevention and testing. That is causing people to contract HIV; it is not just affecting their treatment.

Sharp reductions in support—financial, technical and otherwise—to countries becoming classified as middle income are having a direct impact on the treatment of people living with HIV. To be clear, that is a much bigger debate in international development, but it is a clear example of the impact that is happening.

I will discuss some of those barriers in more depth, but I will start with the cost of treatment. Treatment prices remain one of the biggest barriers to accessing ARV treatment. From my experience in the all-party group and otherwise, the justification that we have often heard for high prices of medications has been the extremely high cost of research and development. Although that is a considerable cost and investment for many pharmaceutical companies, it was enlightening to hear, in one oral evidence session for the report, a pharmaceutical company representative admit that it is not the case that that determines the price. He was clear in saying that the price of treatments is primarily driven by licensing costs and decisions by pharmaceutical companies about what the market will bear.

Intellectual property rights grant exclusive rights to manufacture drugs without competition, and that lack of competition leads to high prices. That said, there is a globally accepted principle that IP rights and patents do not interfere with public health. That was not always the case, however, and in my experience threats to that principle have been overcome only by huge public campaigns.

Governments can bypass IP rights if there is a public health need by imposing compulsory licences. Alternatively, innovator drug companies can agree voluntary licences. Both those ways allow generic pharmaceutical companies to produce quality-assured generic treatments. We saw that first hand during our inquiry, when we visited India and South Africa. We visited generic companies and saw the work that they were doing, and we went to clinics to see the people who were being treated with those drugs, who otherwise would not be receiving any medication. We now have affordable first-line treatments that are available as a result of the voluntary licences, and that has been instrumental in increasing access to treatment.

We now have a price for first-line treatments of around $100 per person per year, whereas 10 years ago it was $10,000 per person per year, so there has been a huge drop in price. Unfortunately, however, if a patient’s first-line treatment is failing and second and third-line treatments are required, the cost of those treatments still remains high.

[Jim Sheridan (Paisley and Renfrewshire North) (Lab)]

I genuinely congratulate my hon. Friend on securing this extremely important debate. Will she expand on the role of the pharmaceutical industry? On page 21, the report mentions that

“a leaked document outlining a lobbying plan for the Innovative Pharmaceutical Association South Africa (IPASA)—the representative body for pharmaceutical companies in South Africa—highlighted the industry’s plans to delay reforms.”

What does that mean?

[Pamela Nash]

We met the South African Government and lobby groups in South Africa on that issue. There was a war between the pharmaceutical companies and Médecins sans Frontières and other smaller groups about this, and it was part of a wider campaign from some pharmaceutical companies to prevent any legislation that might reduce their power to have higher prices. That included such things as “evergreening”, which we have seen in other countries, when patents are granted for a drug because there is a slight change in its chemical composition. Drugs are designed to have a new patent and therefore get round some of the existing patent legislation.

There has been a lot of experience of those companies trying to dodge that, but there are good examples of companies such as Gilead, which have been willing to be at the forefront of being part of voluntary licences and of the medicines patent pool. I do not want to stand here and paint the pharmaceutical companies as the bad guys, because without them we would not have those drugs, but we want to encourage responsible behaviour from them and ensure that they realise what a fantastic contribution they can make to the public health of the world and of people living with HIV.

As I said before the intervention from my hon. Friend the Member for Paisley and Renfrewshire North (Jim Sheridan), there is still a clear problem with second and third-line medication being much more expensive than first-line treatment. In relation to the points that my hon. Friend made, issues have been raised about free trade agreements, in the inquiry and since with the all-party group.

The Transatlantic Trade and Investment Partnership will certainly not be a stranger to the inboxes of most Members in Westminster Hall today. TTIP and the Asia-Pacific Trans-Pacific Partnership—free trade agreements that are under negotiation—seem to pose the risk of introducing additional property rights restrictions or extending patent exclusivity. Although TTIP and TPP do not have a direct impact on the low and middle-income countries that we are discussing, an impact will be felt by them. There is a reasonable fear that the precedent set by those trade agreements will have an impact and shape future agreements.

Any introduction of more onerous patent rules would hinder the ability of generic manufacturers to operate and reduce competition and drive prices back up. That would be disastrous for access to treatment, and our Government must do all they can to protect global public health within these and future agreements. I would be grateful if the Minister clarified today whether the Department for International Development shares any of those concerns and if he put on record his Department’s formal input into free trade agreements. I appreciate that some of that is private, but I am asking how the Department does that and whether he feels that has an impact on the Government’s view as they go into these negotiations.

I shall move on to middle-income countries. During the inquiry, I was particularly struck, more than ever before in my involvement in international development, by the squeeze on middle-income countries and particularly by the impact on the poorest people living in those countries. As I said, this is part of a much bigger debate in international development—it is not confined to HIV—but access to medicine is a clear example of where we might be going wrong.

In providing HIV treatment, middle-income countries in particular are facing a crisis of increased prices combined with reduced financial support. Many of those countries are excluded from the licensing deals that I just mentioned for first-line treatments that allow generic production and supply, forcing them to purchase from innovator pharmaceutical companies at market prices. Those prices are prohibitive and inconsistent. For example, prices for second-line drugs in Argentina are $2,570 per person per year, and the price in Mexico is similar. That is over 12 times the price that South Africa pays at $204 per person per year, which is double the price that I mentioned earlier of $100, which is available for first-line drugs in many low-income countries.

At the same time as they face increased prices, many middle-income countries are having their official development assistance withdrawn from bilateral and multilateral donors. As far as I can see, that has been this Government’s policy, not only in bilateral support, but in using the UK’s influence on the expenditure of multilateral donors to which we contribute, such as the global fund. In addition, we are, in my view, using outdated country classifications and pushing more and more countries prematurely into middle-income status.

When those factors combine, national Governments in middle-income countries are unable to provide services, leading to a treatment crisis. Classification of countries must move away from the current gross national income to a more nuanced analysis. Further support needs to be given to countries, as they graduate through classifications. Decisions about the provision of aid need to be based on need, not just country classifications, although it is completely correct that resources should be prioritised to those who need them most.

Of course, we should expect countries to take on an ever-increasing responsibility for their own development as they become wealthier, but we should not assume that a country with a label of middle-income status has the resources or the technical capacity to cope with aid being withdrawn. The inequality within middle-income countries must be kept in mind. Increasing GNI does not instantly equate to improved living standards or fantastic new health systems, particularly for the poorest and hardest to reach. In relation to access to treatment, funding decisions should be based solely on evidence.

As bilateral donors such as us are withdrawing funding from middle-income countries, so the burden falls on multilateral donors to plug the gaps until countries in transition can fund their services from domestic resources. However, we have seen multilateral organisations following the lead of bilateral donors and reducing support for middle-income countries.

I repeat to the Minister that we should not underestimate the influence that the UK has globally. I say that not with a conceited British ego, but from the experience of speaking to multilateral donors and the people who run those organisations and to people from donor countries and from countries that benefit. When we speak to them, they beg us to bring to DFID the view that this is a huge problem. If a solution to it is to be found, it will require political leadership from the British Government and DFID and a concerted effort to make this issue a priority to ensure that it receives the necessary political attention. Will the Minister tell us whether that is recognised by the Government and whether there is any change in the Government’s thinking on how we look at middle-income countries and their support, particularly on this issue but also more generally?

As I said, the current models of research and development are not delivering all the treatments necessary to meet public health needs. R and D is not prioritised based on need; it is prioritised according to the most profitable products. In our report, we found that there is a gap in relation to treatment for many HIV co-infections, paediatric treatment and diagnostics for small children. Existing models for R and D rely on pharmaceutical companies securing patents that grant exclusive rights to sell the drugs that they develop. If a potential market does not exist, there is currently no incentive to develop products. The need for market advantage reduces collaboration between researchers and increases delays in research into potential vaccines and cures and more effective treatment regimes.

At this point, I want to highlight the fact that in the report we note the disappointment in the UK Government for withdrawing 80% of the funding for the International AIDS Vaccine Initiative and research into an HIV vaccine. Will the Government reconsider that? If not, can the Minister explain why not?

On treatment, a key recommendation in the report is for DFID to play a role in developing new R and D models that are delinked from profits, based on open data sharing and reward people for the development of new clinical technologies, rather than exclusive sales rights being granted. We have recent examples of where what I have described could be a continued problem and where the solution that we have proposed could work. The Ebola crisis is a good example of the failings of the current global model, whereby a vaccine is developed only after a crisis has developed because there was no market incentive to develop one before. Médecins sans Frontières estimates that a vaccine for Ebola will emerge not from a private laboratory, but from publicly funded research.

Models for encouraging innovation in relation to HIV and neglected diseases can broadly be divided into push and pull mechanisms. Push mechanisms reduce the risks and costs of investment in R and D. They include direct funding of research and tax credits, both of which have already been used by the UK Government. The main drawback to push mechanisms, such as direct funding, is that they require funders to make a judgment about which research bodies are most likely to achieve the needed results. Clearly, more research is needed into who would be the best people to make that judgment.

Pull mechanisms, in contrast, create an extra incentive to achieve the result, such as a new medicine, with the benefit delivered only on achievement. Examples of such mechanisms include prizes for the first researchers to come up with a specified innovation, advance market commitments or tax credits on the sale of a certain product that has yet to be developed. There are examples of that already.

We have seen success in delinking R and D costs in relation to the meningitis A vaccine initiative. That developed an adapted meningitis A vaccine through collaborative research, which included the National Institutes of Health and the Serum Institute of India, a private vaccines company. The cost of the vaccine is approximately 50 cents a dose. Furthermore, delinked models of R and D are under consideration for the development of new antibiotics, particularly because there are no incentives for industry to develop products that are meant to be both affordable and conserved or tightly managed.

Our research findings show that the Government could be doing much more to explore the benefits of alternative research models, and I urge them to commission a paper analysing the costs and benefits of alternative R and D models. I ask the Minister whether the Department is considering that. It was a key recommendation of the “Access Denied” report and was previously communicated to the Department.

I want to touch on another finding of the report—the lack of access to viral load testing. We need effective diagnostic tools if we are to provide quality care, but we are seeing very limited investment in that area of research and provision. Viral load testing is the gold standard of diagnostic testing, with increases in viral load indicating treatment failure. If any of us in this Chamber were living with HIV in the UK, we would be undergoing regular viral load testing to ensure the effectiveness of our treatment. The idea is that if the treatment is not effective, people are moved on to second-line or third-line treatment as soon as possible.

In low and middle-income countries, however, viral load testing is limited, which leads to lower standards of care and delays in identifying treatment failure. There have been recent moves to reduce prices, but the tests are carried out only in specialist centres with limited capacity. When I was in India, we went to a clinic and saw the situation at first hand. There was very limited capacity to provide viral load testing. When someone was suspected of having a treatment failure, they had to go in front of a board. There were layers and layers of bureaucracy for such a person. The only justification that I can give is that people there just did not have the capacity and were trying to limit the number of individuals going for viral load testing because they could not afford to send any more. When we met representatives of organisations that were lobbying the Government and, indeed, us on this issue, they told us horrific stories of people who had died waiting to get a test to know whether their treatment was failing. That is something that we do not need to live with in this country, and we have the technology to stop it happening. I feel that we have a responsibility to try to increase the capacity for viral load testing across the world as soon as possible.

Even as the tests are becoming more affordable, there remains a challenge to ensure that these systems are in place. There is a need to develop affordable, accurate point-of-care testing to increase available testing and to reduce delays. That would avoid the need for patients to travel hundreds of miles to testing centres far from their homes and would significantly improve the quality of care received by patients.

Diagnostics are just one area where we see a disparity in treatment between rich and poor countries. We also see that across the spectrum of clinical settings. Distribution networks and health systems in low and middle-income countries are far behind where they need to be. Supply chains are vulnerable to a number of issues, resulting in poor access to treatments. Those challenges include significant delays in registering new drugs, poor demand forecasting and ordering, inadequate storage facilities, stock-outs, corruption and poor patient record management. I would be grateful if the Minister outlined what his Department is doing to address those issues and to support health system strengthening to improve access to treatment, particularly in terms of what we can do to encourage investment in making viral load testing cheaper and more accessible to low and middle-income countries.

The final issue that I will consider is that key populations are being left behind. That has been much debated in the main Chamber and in this room by the all-party group on HIV and AIDS and by our friends among other all-party groups. In addition to the practical, scientific and economic barriers that have been outlined, there are definite social barriers to treatment. The UNAIDS report on the global AIDS epidemic demonstrates that key populations are being left behind when it comes to access to treatment across the globe. The problem is not confined to low, middle or upper-middle-income countries, but it is particularly acute in some upper-middle-income countries—such as former Soviet Union states and countries in central Asia—because HIV epidemics are growing rapidly among key populations.

As MSF pointed out in its submission to our inquiry, the problem of pricing in such countries is compounded by the fact that the epidemics are not generalised but concentrated in marginalised populations. For the avoidance of doubt, I am talking about injecting drug users, sex workers, men who have sex with men, and the transgender population. As I outlined earlier, many global funders actively restrict funding to such countries. That inevitably creates barriers to access for the most vulnerable groups, because there is no political will in those countries to help the key populations that are most affected.

The UNAIDS report highlighted the barriers to treatment created by punitive and discriminatory legislation in many countries:

“As of 2013, 63 countries have in at least one jurisdiction, specific provisions that allow for the persecution of HIV nondisclosure, exposure and/or transmission. Criminalisation of key populations also remains widespread, and 60% of countries report having laws, regulations or policies which present obstacles to effective HIV prevention, treatment, care and support for key populations and vulnerable groups.”

Stigma and discrimination must be challenged wherever they are encountered, whether at a community or a state-wide level. If we do not remove social barriers to accessing testing and treatment, scientific advances will be ineffective. The thing I find most painful about this section of the report is that the position of key populations is not improving but getting worse. There have been many debates in this Chamber about the situation in Uganda and the change in its laws, and there has been much interest in what has happened in Russia. There is cross-party support in the House for fighting discrimination, and I am proud of our country’s record of working to do so. I hope that that will continue.

In conclusion, I am grateful to have had the opportunity to debate this important subject. Hon. Members may think that I have gone on a bit, but I could speak for hours about the detail of the report. It was born out of the huge impact of the report on access to medicines that our predecessor group published in 2009, which I have seen on shelves across the world in countries that I have had the privilege of visiting as chair of the all-party group. A huge amount of progress has been made in the past five years, and a great deal has changed, so I felt that it was time to look at these issues again. As I said at the start of my remarks, despite that progress, so much more can be done. We need to ensure that that happens by working together to tackle the barriers that are outlined in the report.