Increasing Access to Essential Drugs in a Globalised Economy – Working towards solutions
25-26 November, 1999
Amsterdam, The Netherlands
Strategies for increasing access to essential drugs
The need for global commitment
Ladies and gentlemen,
Minister Herfkens is in Indonesia at the moment. She is sorry that she cannot deliver this speech herself, since its subject is close to her heart.
Introduction
Equal rights to a healthy life.
Isn't this one of the cornerstones of a humane society? Good health is something that no one can guarantee or lay claim to. Illness can strike any of us at any time. But good health care is another story. Though that too has its limits, since some treatments are extremely expensive - as are some drugs. Governments can and must draw the line somewhere. But within that line, everyone should have an equal right to treatment. Yet in many countries this right is far from guaranteed. In fact, taking the world as a whole, we are light years away from such a guarantee. Thirty per cent of the world's population does not even have access to the hundred most essential drugs. We are talking here about something as basic as antibiotics for children suffering from pneumonia. This is unacceptable, and it has to change.
What we need first are clear analyses and sound strategies. But what we need most of all is commitment from all those involved: governments in both poor and wealthy countries, international organisations, the pharmaceutical industry and civil society. We are counting on this conference to help achieve the strategies and commitment we need. But first I should like to give you our diagnosis - and prescribe our treatment.
Global contrasts
Even in wealthy countries like the Netherlands, the right to medicines is the subject of continual political debate. And this debate is often highly charged. Insurance companies are under pressure to pay for every treatment on offer. Government attempts to curb spending on medicines meet with considerable opposition. A decision for instance to remove some drugs intended for the treatment of migraine from health insurance packages gave rise to a public outcry.
Many members of the Dutch public haven't the faintest idea what drugs cost. They pay the compulsory charge, and their insurance covers the rest. Every year, the Netherlands spends 8.2 billion guilders on prescription drugs - not including the drugs prescribed in hospitals. This is about 500 guilders a head for every member of the public. And this figure is low compared to some other European countries.
The Dutch regard insurance cover for drugs - and certainly not just the most essential ones - as a right for which they have fought long and hard. And to a great extent the welfare state is willing to concede this right.
This contrasts sharply with the situation in developing countries. Many of the illnesses suffered by the poorest people in these countries could be prevented, treated or even cured with simple pharmaceutical products, such as vaccines and drugs. But according to World Health Organisation estimates, more than half of these people have no access even to the most basic of these products.
What do we mean by access?
Clearly, it means more than having these products on sale at the local store, pharmacy or market. It also means having the right drugs prescribed, in the right dosage, and with instructions on their use. And it is not enough that they are merely on sale. People must be able to afford them. If all this adds up to access, then many people have none. Even if there is a trained doctor near by, a visit often costs too much. Drugs are often sold over the counter, without a prescription.
People often take the wrong medicines, in the wrong dosage, or swallow pills they do no need. There is too little reliable, independent information. Many developing countries have no social insurance system, and people have to pay for the treatment they receive from their own pockets. Poor people are no different from the rich. They too are willing to pay the price of a cure. And they end up spending a large proportion of their income on drugs, which often cost more in developing countries than in the industrialised world.
So poor access places a huge burden on the poor, who often have to take out loans to pay for a useless cocktail of placebos and vitamin pills that are not going to cure them anyway.
There is another, less obvious contrast between rich and poor countries. I have just talked about the drugs that are now available. But what about those that have still to be developed, the cures that are now being sought? Medical research mainly addresses the needs of the wealthy, seeking cures for the illnesses that afflict them. Please do not get me wrong here, it is not my intention to criticise researchers working on a cure for illnesses like Alzheimer's or Parkinson's disease. But in developing countries, malaria and tuberculosis are real killer diseases. Malaria claimed more than one million lives last year, and tuberculosis more than one and a half million. And the incidence of both diseases is on the rise. Because of inexpert use of drugs, the diseases have become resistant to the most commonly used cures. And new treatments are either non-existent or too expensive. In the meantime, research falls far short of need. Malaria accounts for three per cent of illness in the world. Yet only 0.1 per cent of the world's research funds are spent on attempts to find a cure. There is, evidently, too little profit to be gained from the three hundred million inaccessible, impoverished people who have fallen victim to this disease.
According to WHO estimates, fifty-six billion dollars a year are spent on research into medicines. Less than ten per cent of this sum is spent on illnesses that afflict more than ninety per cent of the world's population. The situation is slightly different in the case of HIV and AIDS. Even though the vast majority of victims are in developing countries, HIV and AIDS are a problem in wealthy countries too. But this is no great help. The therapies that have been developed so far are of little or no use to developing countries..
The diagnosis
You need a good diagnosis before you can prescribe treatment. So why is access to essential drugs so poor? There are three basic problems.
The first of these will already be obvious: poverty. Or, in economic terms, lack of money-backed demand. Poor people have too little money to buy drugs, and are therefore not an interesting market for new drugs. They lack knowledge and empowerment. And this makes them an easy prey for unscrupulous doctors and for the marketing strategies of the pharmaceutical industry.
The second problem is that poor people often live in poor countries. If a country is poor, it is unlikely to have enough well-trained doctors. Information provision, infrastructure and organisation will fall hopelessly short. What is more, many governments pursue inadequate health care policies. In some countries they pour money into hospitals, leaving basic health care services short of funds. Unless governments get their priorities right, the prospects for gaining access to essential drugs are bleak indeed for many poor people.
The third and final obstacle is the cost of drugs. The World Health Organisation has compiled a list of three hundred and six drugs which together could more or less cure ninety-five per cent of known illnesses. The patent on an estimated 85 to 90 per cent of these drugs has expired. And this means that they need not be so expensive.
Things are different as soon as patents come into play, since they can push prices up. The patented HIV therapy AZT, for instance, costs fifteen thousand dollars a year per patient. A similar unpatented drug would cost just three thousand dollars. And with the conclusion of the agreement on Trade Related Aspects of Intellectual Property Rights (or TRIPs) in 1994, it is likely that prices will rise even further in the next few years. The agreement obliges its signatories to observe certain minimum standards with regard to intellectual property rights.
The challenge
The challenge now confronting us is clear:
- poor people must have access to affordable essential drugs;
- more research is needed into the illnesses afflicting the poor;
- the medicines this research produces must be available to those who need them.
Meeting this challenge will literally make the difference between life or death for millions of men, women and children.
The cornerstone of any credible development policy should be tangible improvements to health. Any investment in health pays off - with interest. For it is not just the individual that benefits. Society too stands to gain, for healthy people are better able to compete on the world market.
I am glad to say that the picture is not entirely bleak.
One outstanding example. Until recently river blindness was a curse that afflicted many Malinese. One person in fifteen was infected, and many turned blind, often at an early age. "Marry young, so you can at least see your wife" - that is what they used to say in Mali. The all too familiar picture of blind people on the street or in the bus, being guided by a young child, will gradually belong to the past. The programme the World Health Organisation and the World Bank is now conducting is a textbook example of cooperation between the public and private sector. The manufacturer is supplying the crucial drug free of charge. For many years, the Netherlands has been one of the programme's major donors, and this year it has agreed to release another ten million guilders to stamp out river blindness once and for all.
I wish things always went so well. What was the secret of our success in dealing with river blindness? What treatment fits my diagnosis?
What approach should we adopt?
Effectiveness and efficiency are the watchwords.
In the past, discussions often lapsed into endless ideological debate, with left and right pointing the accusing finger at each other. This got us nowhere. Pharmaceutical multinationals are not by definition evil. And the free market is not by definition good. The important thing is to get the right medicines to the right people at the right price. It doesn't matter whether we turn left or right. We have to avoid wearing ideological blinkers. We must judge measures and strategies on their merits. That sometimes means leaving things to the market. But it also means that we have to be prepared to intervene if the market mechanism fails.Consumers have the right to proper information, and their voice must be heard. The pharmaceutical industry is a crucial partner, but that does not mean we should give it carte blanche.
Let's call it the Ghandi test. Ghandi believed that every new technology should be judged by its impact on the poorest people. And that also applies to strategies on drugs.We believe that in our efforts to increase access to essential drugs we should be pursuing a triple strategy that stems directly from the diagnosis.
- First, the public and private sectors should work together on research into and the distribution of medicines and vaccines, as in the river blindness programme.
- Second, we should support efforts to improve health care services in developing countries.
- Third, we should assess international trade agreements on their merits, and relax or tighten them where necessary.
I should now like to take a look at each of these points in turn.
1. Public-private cooperation
For the private sector, investing in research into the diseases of the poor poses a risk, since it is unlikely that the returns will be high. This is where the market fails: socially desirable research cannot get off the ground.
A number of ideas have been mooted recently on how public funds can be used to give private initiative a push in the right direction. If the market cannot guarantee a profit, and the risks are too high, why can't the public sector bear some of the risk by, for instance, guaranteeing sales of certain vaccines? Interaction of this kind is very promising, provided tasks are allocated properly. Research projects set up without private funding are usually too marginal and too ineffective, since their budgets can never match the immense sums the major companies are able to spend. The Global Alliance for Vaccines and Immunisation (or GAVI) - the initiative launched by the World Bank last year - promises to get off to a roaring start. This new fund should serve as an incentive to the pharmaceutical industry since it guarantees a market for vaccines that are of particular importance to developing countries. Apart from international organisations and bilateral donors, its backers also include the Gates and Rockefeller Foundations. A total of a billion dollars is believed to have been pledged to GAVI which also includes an international fund for children's vaccines. And there are more initiatives like GAVI, such as the Special Programme for Research & Training in Tropical Diseases (TDR) and the Medicines for Malaria Venture (MMV). The Netherlands will be allocating substantial funds to these initiatives this year and next.
2. Improving health care services
The Netherlands is helping to strengthen the health care sector in twelve countries. Increasingly, it is adopting a sectoral approach, abandoning the policy of running isolated projects. The health care policies of the recipient governments form the basis.
Three principles are at the heart of the sectoral approach: ownership, donor coordination and coherence. In most cases, capacity building is crucial if countries are to pursue successful health care policies. The same applies to policies aimed at increasing access to drugs. Governments have a number of key tasks. Among them are:
- compile a list of medicines needed to treat the diseases prevalent in their country, that they can actually afford;
- ensure these medicines are purchased and distributed;
- promote rational use by health care workers and their patients;
- and monitor the quality of the medicines supplied.
Essential drugs programmes are an integral - and highly important - part of health care policy. The availability of these drugs has a considerable impact on the take-up of health care services. Fortunately, the Netherlands is not the only country to adopt this approach. More and more donors and international organisations are following the same line. The main thing is to act on the problems identified by the recipient governments themselves.
Specialised UN agencies can provide support in certain areas. Where essential drugs are concerned, the World Health Organisation is a major partner for many governments.
Vaccines are a special case. Investing in vaccines pays off. Every dollar spent on effective vaccination means sixteen dollars saved on medical costs. Yet vaccination coverage has levelled off and even decreased in recent years. It is a disgrace that new vaccines against hepatitis B for instance have hardly made an impact on vaccination programmes.
3. International rules and agreements
I come to my third point: assess the agreement on intellectual property rights, the TRIPs. The agreement, made in 1994, now is part of the framework of the World Trade Organisation (WTO). In early December, members will meet in Seattle to discuss implementation of the entire package of measures agreed in 1994. This covers far more than TRIPs alone. For the debate on access to drugs, however, TRIPs are the main concern.
There is one main reason for protecting intellectual property rights.
It is a well-known fact that about eighty percent of all research into new medicines fails to yield workable results. New treatments that make it to the finishing line have to undergo expensive and exhaustive tests. So it is not so much the manufacture of medicines that costs money, but the work that goes into developing and testing them. This money has to be recouped - hence patents.
Under the TRIPs, title-holders will get the sole rights to their product for a period of twenty years. Decent patent laws are the reward for years of research, and act as an incentive to seek new, more effective medicines. But this advantage comes at a price.
Patents can push the prices of new medicines up. For the title-holder has a monopoly and can ask what he wants - within certain bounds, of course. Rich countries can afford to pay. Poor countries are not so fortunate, however. What we need to do is strike a balance between protecting intellectual property rights and protecting the interests of health - a balance, in short between the interests of the producers and those of consumers. It is, after all, unthinkable that an AIDS victim should have to wait twenty years for treatment, until the patent expires. If this is what TRIPs leads to, then we are on the wrong path.
Developing countries believe that they have little to gain from the TRIPs agreement. The vast majority of patents - an estimated ninety-five per cent - are in the hands of people in the industrialised world. The higher price people in developing countries will have to pay because of these patents will in effect mean an income transfer from poor to rich. What is more, the need to draw up a completely new body of legislation is both expensive and time-consuming for these countries. The pro-TRIPs lobby, on the other hand, argues that poor countries also stand to gain by this agreement. It will encourage local pharmaceutical companies to do more research into local diseases. Moreover, a system of patents and licences would stimulate technology transfer, and investment in developing countries.
So far, precious few of these benefits have been reaped. But the disadvantages are already being felt. I therefore believe that some parts of the TRIPs Agreement deserve scrutiny.
First, we should come out firmly in favour of compulsory licences, enabling governments to issue licences to national producers without the permission of the title-holder. Such a measure could lead to a seventy-five per cent drop in prices.
South Africa recently adopted a law that allows compulsory licensing. And it found itself under attack from a number of wealthy countries. Fortunately, South Africa won the first battle. Medicines to treat AIDS victims can now be produced locally.
We cannot accept the kind of bilateral dealings in which one county puts pressure on another to enforce certain laws, or refrain from enforcing them. The United States, for instance, has recently concluded bilateral agreements with both Albania and Sri Lanka curtailing their right to introduce compulsory licensing. What the Netherlands wants is an open, transparent, multilateral system. And that applies to TRIPs too.
The second point has to do with permitting parallel imports.
The prices of medicines can vary widely from one country to another. Every country has the right to go in search of the cheapest supplier of a certain medicine. In an effort to protect its own interests, the pharmaceutical industry would like to see imports of this kind banned. I am against introducing such a ban.
Thirdly, we need to allow developing countries enough time to comply with the TRIPs agreement. The current deadlines are unrealistic and unbalanced. Developing countries have to be given the chance to set up a system op property rights that suits their own development process. I wholeheartedly support the proposal to tighten up agreements on technology transfer to developing countries.
Many more proposals have been tabled on ways of tightening up or relaxing the TRIPs agreement. The organisers of today's conference have published an open letter in which they list a whole series of proposals, such as exempting essential drugs from patents.
It is too early to give a final judgement on these proposals, some of which still have to be worked out in detail. There are surprisingly few hard facts regarding the effects of patents on prices, on research and development spending and on foreign investment.
This Spring, in its Revised Drugs Strategy, the Assembly gave WHO the mandate to monitor the effects of international trade agreements on health care. We were delighted with this decision. WHO must draw up a research agenda together with the WTO and the World Bank. It is impossible to overestimate the importance of research and monitoring.
Together with her fellow ministers for trade and health care, the minister for development cooperation will ensure that the Dutch government does all in its power to find solutions to the problems associated with TRIPs.
Conclusion
In my view, lack of access to essential drugs is such a complex social disease that no one single treatment will cure it.
My prescription is as follows:
- improve health care in developing countries;
- use public/private cooperation to develop and distribute medicines;
- introduce international laws that strike a better balance between private and public interests.
Discussion and research will be needed before we can decide precisely what the dosages should be. At every step, we must ask ourselves what impact this will have on someone who earns less than a dollar a day. I hope that this conference will give us some answers.