Policy Division
Access to Medicines
Questions and Answers
1.Introduction | 2.Trips and Public Health | 3.Drug Procurement | 4.Malaria | 5.HIV/AIDS
What are the key factors affecting access to medicines?
With the World Health Organisation (WHO), DFID believes that affordable pricing, sustainable financing, reliable health and supply systems, and the rational selection and use of drugs are all essential to improve access to medicines. The research and development (R&D) of new products is also critical to ensure access to medicines, particularly over the longer term. In June 2004, the UK Government released a new paper entitled Increasing access to essential medicines in the developing world: UK Government policy and plans (208 kb), which sets out the UK response to this pressing global health issue.
What support has DFID given to health system strengthening?
In line with the approach outlined above, DFID has committed over £1.5 billion since May 1997 to support the strengthening of health and supply systems in developing countries, which will help to build capacity to deliver medicines to the poor and to make effective choices about the selection of drugs. The UK has also pledged £259 million to the Global Fund to fight AIDS, TB and Malaria (GFATM) through to 2007/08. This will help pay for increased coverage of proven interventions for the three diseases and some associated health systems strengthening.
Who is DFID working with to increase access to medicines?
DFID is committed to working with a broad range of stakeholders, including our developing country partners, donor governments, non-governmental organisations (NGOs), the pharmaceutical industry and their investors to improve access to medicines in developing countries. A partnership approach between these stakeholders is essential to making progress.
What has DFID achieved in its work to improve access to medicines?
There have been important international successes over recent years, including the G8 commitments on access to medicines at Evian last year, and the resolution of outstanding issues within the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement (through the TRIPS and Public Health Decision of August 30th 2003, allowing countries with no, or insufficient, pharmaceutical manufacturing capacity to import copies of patented medicines - see below for more detail). In addition, the European Union put in place a Regulation to encourage differential pricing of medicines by tackling the threat of ‘diversion’ where, rather than reaching intended recipients, medicines are re-routed to rich markets. Furthermore, there has been a lot of activity to increase research and development into medicines for diseases disproportionately affecting developing countries. The UK has been central to this. We have also supported the establishment of a time-limited Commission at WHO to look at issues of innovation and intellectual property in health for developing countries.
What is TRIPS and what are the concerns?
The World Trade Organisation (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement) lays down minimum standards for intellectual property protection in WTO Member States. A major concern in developing countries relates to the implications of the extension of intellectual property protection for poor people's access to medicines - most notably, the impact that the implementation of the TRIPS Agreement either has had or will have (when fully implemented) on the price of patented medicines.
What is the Doha Declaration?
In recognition of the gravity of the public health problems afflicting many developing and Least Developed Countries (LDCs) - especially those resulting from HIV/AIDS, TB and other epidemics - the WTO produced a Ministerial Declaration on TRIPS and Public Health (Doha, November 2001). This reaffirmed the flexibilities within the TRIPS Agreement, stating that the Agreement does not, and should not, prevent countries from taking measures to protect public health. In effect it confirmed the status quo, whereby each WTO member has the right to utilise TRIPS-compliant measures, including the issuing of a compulsory licence (CL), in the face of a public health need. The Declaration also extended to 2016 the date by which LDCs need to implement their obligations in the pharmaceutical sector under the TRIPS Agreement.
What about ‘Paragraph 6’ and countries with insufficient or no manufacturing capacity?
Paragraph 6 of the Declaration recognised that, since any medicines produced under a CL had to be predominantly used in the domestic market, countries with no, or insufficient, capacity in the pharmaceutical sector were unable to benefit from CLs. Prior to 2005 this is not a problem since some of the countries producing copies of patented medicines are developing countries that have not fully implemented TRIPS - India, for example. After 2005, most of these developing countries are obliged to implement TRIPS. These countries will be able to continue to make copies of existing patented medicines for export to other countries but they will not be able to copy newly patented medicines that come onto the market after 2005 (and in some cases, post-1995 medicines might be affected as well). The Declaration mandated the TRIPS Council - the WTO body that administers the TRIPS Agreement - to find a solution to enable countries with insufficient or no manufacturing capacities in the pharmaceutical sector to make effective use of the compulsory licensing provisions already present in the TRIPS Agreement. It is on this issue that agreement was reached in Geneva, on August 30th 2003, immediately before the WTO Ministerial in Cancun in September 2003.
What was actually agreed on 30 August 2003?
The TRIPS and Public Health Decision (30 August) lays the legal groundwork to allow poor countries with no, or insufficient, manufacturing capacity in their pharmaceutical sector to import copies of patented medicines. These can be imported, from countries such as India, following the issuing of a compulsory licence in both the importing and exporting country.
The Decision is a significant step. It should help increase supply and availability through market competition, and should also help to reduce the price in poor countries of patented medicines that come onto the market after 2005. The option to use compulsory licensing provides countries with a useful bargaining tool for negotiating prices with suppliers of patented medicines and should encourage the latter to reduce prices.
Some NGOs are saying that the agreement will not help. We disagree - the new provisions should provide a greater incentive for a pharmaceutical company to reduce medicine prices because it knows that a purchasing country, for example Uganda, might be able to issue a compulsory licence to import a cheaper generic copy of the same product, which it could not otherwise do. That would be a lost sale. So it is better for the company to reduce its price to the lowest level possible. If that is still too high, Uganda could still import from India. Either way prices should come down. We are committed to monitoring the longer-term impacts of the agreement on the pharmaceutical market in developing countries and have already commissioned relevant studies.
How have developing countries reacted? Developing countries had signed up to this agreement in December of 2002 and have therefore welcomed the fact that the entire WTO Membership has now come on board. India in particular have issued a statement noting that the Decision "is a landmark because it recognises the primacy of public health needs and the sensitivity of WTO to the problems faced by the poor in the less developed countries." Several developing countries are already preparing to use the flexibilities offered by the Decision.
Will India still continue to produce generic copies of medicines? Will they not be forced into making patents available on the newest medicines which will prevent them being exported? India must offer patents from 2005 on new medicines (or post-1995 drugs for which a notification to patent has been submitted). But the agreement reached still allows India to issue compulsory licences to produce generic copies, including for export if requested. Currently India has a large generic manufacturing industry, and a nascent research-based industry that will benefit from the extension of patent protection under TRIPS in 2005. There will continue to be significant market opportunities for India’s generic industry, manufacturing all generic drugs currently on the market and others as they go off-patent, and manufacturing under compulsory licence.
Does the Agreement mean that AIDS sufferers everywhere will be treated? Unfortunately, the cost of medicines is not the only issue preventing access to medicines. Issues such as being able to reach, diagnose, treat and care for sufferers are as important. And sadly too little money is being spent on this. The UK Government has since 1997 committed £1.5 billion to strengthening healthcare infrastructure in developing countries, but of course more needs to be done - which is why for instance we have increased our annual bilateral spending on HIV/AIDS from £38m in 1997 to £270m in 2002/03 and why we strongly support the Global Fund to fight AIDS, TB and Malaria (GFATM). In July 2004, the UK launched its Strategy for tackling HIV and AIDS and announced a commitment to additional spending of £1.5bn on HIV and AIDS over the next three years.
Was the Agreement not all a bit "too little too late"? No. Although the deadline was missed by over eight months, WTO members were able to resolve this issue before Cancun. It shows that the WTO can make trade rules that are in the interests of developing countries.
Does the UK support the use of generic drugs?
Yes. We support developing countries to select drugs that are affordable, safe, effective, and of appropriate quality. These may be ‘originator’ brands or generic. Obviously, it is very important that all drugs are quality assured. WHO’s pre-qualification process can provide appropriate assurance to developing country regulatory authorities without the capacity to undertake the necessary tests prior to registration.
However, it should not be assumed that generic drugs are necessarily a better option that those produced by research-based companies. Large pharmaceutical companies invest significant sums in the development of new medicines, and their production, distribution and quality control systems are of the highest quality. In some cases, their prices may be lower too. It is therefore vital that these companies are involved in the provision of affordable medicines.
Will the UK fully implement the WTO TRIPS waiver agreed in August 2003 allowing developing countries with insufficient capacity in their pharmaceutical industry to import copies of on-patent medicines? Yes, the UK Government is fully committed to the Doha Declaration on TRIPS and Public Health and to facilitating the implementation of the TRIPS and Public Health Decision reached at the WTO on 30 August 2003. Three strands of work are already underway:
- Working with other WTO Member States via the EU to amend the TRIPS Agreement;
- Amending UK patent legislation in the context of a coherent EU approach;
- Funding research and capacity building to facilitate implementation of the Decision at country level.
Will the UK provide assistance to developing countries to make best use of TRIPS flexibilities in order to facilitate access to medicines? The UK is committed to ensuring countries are well placed to utilise appropriate TRIPS flexibilities, including in relation to their domestic pharmaceutical production. We are taking forward work to look at the technical assistance countries need to implement and use TRIPS appropriately, and to understand the likely impact of the full implementation of the TRIPS Agreement in all remaining countries - except for Least Developed Countries - in 2005. In some countries, such as Ghana, we are already supporting government and other stakeholders to take steps to ensure increased access to medicines for their populations within the context of a changing trade and intellectual property environment.
Does DFID procure drugs?
DFID rarely procures pharmaceutical products directly. Where it does it uses one of its appointed Procurement Agents to ensure effective and efficient procurement and maximise value for money. Development assistance channelled to global health partnerships or international agencies such as WHO may also be used to procure pharmaceutical products. Generally these funds are provided with no or limited earmarking. At country level, DFID increasingly provides resources through direct budget support or sector-wide funding, again with no or limited earmarking. UK Development Assistance has been untied since 1 April 2001. This means that goods or services procured through the Development Assistance programme can be sourced globally - there is no preference for UK domestic sourcing. The UK’s commitments in this area are set out in the 2000 White Paper on International Development.
Who decides which medicines to procure?
We would support the right of developing country governments to decide how and from where to procure pharmaceutical and healthcare products, in line with their own procurement rules and their National Drug Policy. We support WHO’s efforts to promote and assist the development of national Essential Medicines Lists, to support drug procurement and use, and to develop a pre-qualification programme for the assessment of key medicines. This gives developing countries greater assurance over the safety and efficacy of products they wish to procure, and can help support a policy of generic substitution where appropriate in order to limit healthcare costs.
What is the UK stance on pre-qualification of drugs?
Some have raised questions over the standards applied through the WHO pre-qualification process. We believe that WHO is the appropriate body to set international norms and standards for public health. It is likewise appropriate that they should seek to apply internationally agreed standards in the area of drug testing and quality assurance, in order to ‘pre-qualify’ drugs (particularly generics). We do not wish to see a proliferation of such standards and processes, which will prove burdensome to countries and could lead to widespread inconsistencies.
How can the UK assist if a partner government requests procurement support, or their procurement capability is judged to be lacking?
It is widely acknowledged that health procurement systems are weak in many developing countries. Assistance can be offered by the use of DFID's Procurement Agents who can manage the procurement on behalf of either DFID or the partner government. DFID Procurement Agents are familiar with issues and mechanisms related to access to medicines. Alternatively, technical assistance and/or capacity building services may be offered to the partner government to strengthen domestic procurement capacity.
Is DFID committed to combating malaria?
Yes. DFID is dedicated to improving the lives of people at risk or suffering from malaria. Reductions in the incidence of major diseases including malaria form the 6th Millennium Development Goal. DFID contributes at international and country level. For example, DFID is an active member of the global Roll Back Malaria (RBM) Partnership to which we have contributed £48 million over a four and a half year period. RBM provides coordinated support for sustainable action against malaria, which includes providing technical support to Governments on malaria prevention and treatment policies. It promotes the use of insecticide treated nets and recommends accessible, affordable and appropriate medicines.
Has DFID been instrumental in gathering evidence about malaria?
Yes. For example, since 1998, DFID has supported the East African Network for Monitoring Anti-malarial Treatment (EANMAT), which carries out high-quality drug efficacy testing and feeds this information into policy-making. This network has been instrumental in documenting increasing drug resistance - first to Chloroquine and then to Sulphadoxine-Pyrimethamine (SP) - and has supported drug policy review and revision in EANMAT participating countries. We plan to continue to support this project for a further three years.
What about drug resistance and the use of Artemisinin-based Combination Therapy?
Due to the increasing incidence of resistance to drugs such as Chloroquine and SP, WHO advice on effective anti-malarial drugs has changed. Recent advice recommends the use of combination therapies, preferably those containing artemisinin derivatives, where resistance to single therapies has developed. Artemisinin is a naturally occurring substance that has been used in China in the treatment of malaria for a long time. Artemisinin compounds can be used by themselves, but are more useful when combined with other effective anti-malarials as the combination cures malaria faster and also slows the development of drug resistance.
Artemisinin-based Combination Therapies (ACTs) are, like many new treatments, relatively expensive compared to the options they need to replace. This highlights the need for the UK Government to work with others to reduce the cost of drugs. DFID is working with other UK Government departments and external stakeholders to secure greater international commitment to affordable pricing. For example, we worked with G8 colleagues at the 2003 Evian summit to secure commitment to action on this issue.
As an active partner of RBM, DFID works to ensure that the initiative provides sound evidence based support for the effective use of resources, including those available from the Global Fund to fight Aids, Tuberculosis and Malaria (GFATM). RBM is currently reviewing procurement mechanisms for ACTs to identify more cost-effective options, and they are developing a Malaria Medicines and Supplies Services (MMSS) to support the procurement and use of medicines and other health commodities such as bednets. RBM is also developing a ‘road map’ to increase access to ACT in 2004/2005, particularly to address operational bottlenecks at the country level. The accuracy of diagnostic systems for malaria must also be improved particularly in view of the relatively high costs of treatment with ACTs. Internationally, we also need to undertake further testing to address the concerns that exist around the safety of using these drugs - particularly for pregnant women and those of reproductive age.
What about UK support to developing new anti-malarials?
DFID has engaged significantly in partnerships with industry to transform research into drugs. We recently worked with GlaxoSmithKline, the WHO programme on Tropical Disease Research and Liverpool University in the development of a cheap new anti-malarial called LAPDAP. In order to make the best use of LAPDAP, further research to combine it with artemisinin is being undertaken. This is being managed under an umbrella organisation called the Medicines for Malaria Venture (MMV), which DFID also supports. Since its inception in 1999 MMV has demonstrated significant progress towards reaching its objective of 2 new drugs in the next 10 years. UK research institutions such as the Medical Research Council, the Wellcome Trust, and universities such as Oxford, London and Liverpool, have also been critical players in research to understand the malarial parasite and develop appropriate anti-malarials.
What about prevention efforts?
Indeed, use of ACT is not the only anti-malarial strategy that countries must employ. Another cost-effective intervention is the promotion of the use of Insecticide Treated mosquito Nets (ITNs) especially for children under five years and pregnant women. ITNs are known to reduce the incidence of malaria and can therefore prevent illness and death. They are cheap, safe, easy to use and if used properly can last a long time. Increased availability and use of ITNs would greatly reduce the malaria burden in developing countries. The Abuja Declaration of 2000 committed governments to ‘reduce or waive taxes and tariffs (T&T) for nets, and materials, insecticides, anti-malarial drugs and other recommended goods and services that are needed for malaria control strategies’ in order to make these goods and services more affordable to the poor. So far, eighteen developing countries have reduced or eliminated T&T. However, the process of rationalising T&T is extremely complex and RBM has been working to review country experiences in order to learn lessons for the benefit of others.
Effective health systems are absolutely key to the effective prevention and treatment of malaria. Many poor countries still have too little capacity to deliver treatment and care for malaria safely, effectively and on a large scale, regardless of the cost of drugs. That is why, as stated above, we have committed £1.5 billion since 1997 to help developing countries strengthen their health systems.
The new UK Strategy
The UK Government is committed to halting AIDS and reversing the spread of HIV globally. The challenges facing the world were set out in the UK’s Call for Action on HIV/AIDS published in December last year. Taking Action: The UK’s strategy for tackling HIV and AIDS in the developing world was launched on 20 July 2004 by the Prime Minister and sets out how the UK will respond. We will:
- Promote a comprehensive response to tackle prevention, treatment and care as well as addressing the social impacts of AIDS;
- Make sure that the needs of women, young people including orphans are prioritised;
- Focus on human rights and stigma and discrimination;
- Ensure that responses to AIDS are sustainable in the long term as well as responding to immediate needs.
The UK Government will spend at least £1.5 billion over the next three years on AIDS related work in the developing world. The new strategy will give special focus to tackling the impact of AIDS on women, young people and orphans and children made vulnerable by AIDS. Of the £1.5 billion at least £150 million will be dedicated to helping orphans and other children made vulnerable by AIDS, especially in Africa. We have committed £80 million for the United Nations Population Fund (UNFPA) and £36m for the Joint United Nations Programme on HIV/AIDS (UNAIDS) to address the needs of the most vulnerable. We will invest in comprehensive programmes - bringing together action to further HIV prevention, care and treatment and steps to reduce the impact on societies. AIDS is not just about health. The UK Government will promote human rights and take steps to overturn stigma and discrimination which fuel the epidemic and stop people from getting the care and the advice they need. We are doubling our contribution to the Global Fund with an additional £77 million over the next 3 years.
What is being done to increase access to medicines for people living with HIV/AIDS?
The fight against HIV and AIDS requires efforts on many fronts, including in relation to increasing access to medicines for people living with HIV and AIDS, and developing new treatments, vaccines and microbicides.
The UK Government is committed to increasing access to medicines for people in developing countries, not just for HIV and AIDS, but for all priority health needs. As set out above, we are working with a number of stakeholders in order to progress international commitment and action.
For HIV and AIDS, the last 3 to 4 years have seen prices for anti-retrovirals (ARVs) come down by up to 98%. This has been achieved through international action such as the establishment of the Global Fund to Fight AIDS, TB and Malaria, individual company activities, initiatives such as the Accelerating Access Initiative, and competition from generic manufacturers.
We welcome recent reductions in the price of both originator and generic ARVs for the treatment of HIV. These reductions have created new opportunities to allow poor people to benefit from the same life-saving treatment that has been available in affluent countries. We will continue to work with the WHO, the research-based and generic pharmaceutical industries and others to further reduce drug prices and to ensure the continued development and supply of drugs that are appropriate, safe and effective.
We have also provided strong support to research, including more than £17 million to microbicides research and £14 million to the International AIDS Vaccine Initiative.
What is the UK policy for treatment and care for people with AIDS?
The UK supports efforts to provide increased, and eventually universal, access to treatment and care for people with AIDS. We support the WHO and UNAIDS ‘3 by 5’ goal to provide anti-retroviral therapy to 3 million people in developing countries by the end of 2005, of which 2 million will be in Africa. Our view is that at least 50% of these people should be women and children. We have committed an additional £3m to WHO in 2004 to support 3 by 5 activities.
Support for treatment and care reflects a shift in policy for the UK, based on equity considerations, improved effectiveness of treatment programmes in resource-poor settings, significant changes in the costs of treatment, and a greater understanding of the fundamental importance of care and treatment in effective responses to AIDS, including in terms of restoring hope, reinforcing prevention efforts, prolonging life and reducing the numbers of children growing up without carers.
However, increased emphasis on treatment and care does not mean abandoning prevention and impact mitigation. It is vital that comprehensive prevention efforts, voluntary counselling and testing, ARV therapy, treatment and prevention of opportunistic infections (including TB), home based care, palliative care, and impact mitigation are all part of the fight against AIDS.
The UK is directly active on AIDS in nearly 40 countries. Bilateral funding supports the national HIV/AIDS strategies of developing country partners, involving all relevant parts of government. We have successfully worked to push the crisis up the agenda in all international bodies including the UN, the G8 and the EU. We are also working with non-governmental, private and multilateral partners to improve prevention, treatment and care programmes.
Why three million?
The number of three million is based on UNAIDS estimates of the maximum number of people that could be reached with treatment, given current infrastructure, by 2005. It represents a significant scaling up of current effort. Three million is estimated to represent 50% of those people who will be in need of treatment by 2005.
How many people globally are currently on ARVs?
Currently there are 800,000 people worldwide on ARVs. Only 400,000 of these are in developing countries. In Africa, only 1% of people who need ARVs are currently receiving them.
How important are microbicides to tackling HIV and AIDS?
Women-friendly technologies, such as microbicides, will be an essential component of an effective HIV response, enabling woman to take control of their lives. Even an only partially effective microbicide to prevent sexual transmission of HIV could prevent 2.5 million deaths from AIDS every three years. We welcome the fact that five clinical field trials of different microbicide candidates will be launched in 2004. It will be important to complete these trials in order to identify the most effective product.
How is DFID supporting the development of microbicides?
We are providing a grant of £16 million over five years (2001-2006) for the Microbicide Development Programme (MDP), co-ordinated by the Clinical Trials Unit of the Medical Research Council (MRC) and Imperial College. The programme is investigating the effectiveness of promising microbicide products, involving research centres in 5 African countries. DFID support accounts for over half of the projected costs.
We have been in discussion with other donors concerning support to the current generation of phase III trials, including the MDP’s. Discussions have focused on ensuring the completion of trials, how best to utilise the data collected and how to ensure new candidates were being brought into early clinical studies. Our new HIV and AIDS Strategy and the recent UK Government paper on access to medicines set out how we will work, including with other donors, to further the development of technologies to combat HIV and AIDS, including microbicides.
Will the MDG to have halted and begun to reverse the spread of HIV/AIDS by 2015 be achieved in Africa?
The latest analysis in UNAIDS "AIDS epidemic update" (December 2003) concludes that there has been no overall decline in sub-Saharan Africa’s HIV epidemic and that without effective interventions, it will continue to undermine Africa’s development effort. That is why the "UK’s Call for Action on HIV/AIDS" and the recent UK Strategy made explicit our commitment to significantly increase our efforts to address HIV/AIDS and poverty over the coming year and beyond.
However, there are good stories to tell. The experience of Uganda shows that with political will the tide of an epidemic can be turned; Senegal shows us that if properly addressed in its early stages the epidemic can be contained. Other African leaders have shown political commitment to the New Partnerships for African Development (NEPAD) that has tackling HIV and AIDS as a priority.
Is progress being made on donor harmonisation?
Tackling HIV and AIDS requires the concerted effort of the whole international community. The current response is highly fragmented. The involvement of new bodies such as the US President’s Emergency Plan for AIDS Relief, the Global Fund and the Gates Foundation has brought much-needed funding. However, donors as a whole have often failed to work in a coordinated way. Instead many are still demanding separate plans and processes from partner governments.
In Washington recently, a meeting hosted by UNAIDS and co-chaired with the UK and US, agreed the core principles underpinning AIDS programming by donors, under the framework of a country-driven process. The result of the meeting - the "Three Ones" - affirms the need for each country to have:
- One agreed HIV/AIDS Action Framework for each country that drives alignment of all partners.
- One national AIDS authority, with a broad-based multi-sectoral mandate.
- One agreed country-level monitoring and evaluation system.
Further, the United Kingdom and Norway pledged to work together and with others to develop the idea of a "Fourth One" - donors streamlining at country level behind one financial mechanism with a single lead donor.
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