Proposition 52K1828

Proposition de résolution concernant l'accès aux médicaments essentiels dans les pays en développement.

General information ¶

Authors

Open Vld Yolande Avontroodt, Maggie De Block, Hilde Vautmans, Katia della Faille de Leverghem

Submission date

Feb. 18, 2009

Official page

Visit

Status

Adopted

Requirement

Simple

Subjects

medicinal product product quality resolution of parliament industrial counterfeiting development aid developing countries export public health

Voting ¶

Voted to adopt

Groen CD&V Vooruit Ecolo LE PS | SP Open Vld N-VA LDD MR FN VB

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Discussion ¶

Jan. 28, 2010 | Plenary session (Chamber of representatives)

Full source

Mr. Speaker, in the absence of the main author of this resolution, of which I know it is not far away, I will present you a brief report.

This resolution draws our attention to the fact that, on the one hand, Belgium is making significant efforts in development cooperation in the field of health, in particular in the area of essential medicines, and, on the other hand, that these efforts towards the poorest countries can be wiped out in the event of problems with counterfeit medicines.

In some cases, up to 25% of medicines in developing countries are counterfeit. In Cameroon, 70% of malaria medicines are counterfeit.

The problem is therefore ⁇ serious. Ms Vautmans and her other colleagues would like to insert in the resolution arrangement not only the need for increased vigilance, but also the intervention of a European regulation on these issues of medicines intended for third countries, with special vigilance within the framework of Belgium’s development cooperation programmes.

There was a discussion in the committee.

While supporting the objectives of the proposal, Mr. Van den Eynde, for the Vlaams Belang, considered it difficult to maintain vigilance given the lack of control over the manufacture of counterfeit medicines, in particular because they were produced on-site. By the way, as regards the implementation of devices in developing countries, he had doubts about the capacity of these countries to implement such devices.

by Mr. Baeselen intervened to show his interest in the resolution, to say that he had had talks with United on this issue, ⁇ as part of Philippe Douste-Blazy’s visit to the Senate in December 2009, and that he found it interesting to study the possibility of a tax on airline tickets, as does France in the fight against AIDS. He also highlighted the need to focus on access to patent-protected medicines and advanced medicines.

by Mr. Versnick intervened to say that the issue of introducing an additional tax was praiseworthy, but not a good idea in principle and that there were other possibilities for action for public authorities.

I also participated in the discussion and will talk about it personally later.

by Mr. Mark Verhaegen for CD&V thought this was an interesting resolution. He would have liked to have more time to discuss related topics. The author of the resolution thinks these topics are interesting but she wanted a resolution on certain specific points. I think we can go back to a broader discussion later.

This is the main point of this resolution, which was unanimously adopted by the members of the committee.

Personally, I would like to add that I once again congratulate the author of the resolution for his initiative. This moral issue is extremely important. The worst of counterfeits is that of medicines. It kills people who think they have access to effective medicines. In addition, it should also be known that for many families in poor countries, the budget for medicines is extremely important. Some families ruin themselves to get these medicines. When it comes to pure placebos, or even dangerous drugs, it’s a scandal.

Systematically, in our cooperation projects, especially in the areas of health, I think that we need to be very attentive to the issue of access to quality medicines. We need to have devices that allow us to control the quality of the medicines we make available to the public, whether they are provided through cooperation programs and projects or are located in the areas and countries in which we work.

I repeat, it is a real scandal to see families ruin themselves for medications that are not. I have known families whose one member prostitutes to be able to buy medicines to fight tuberculosis, for example. Eventually, they realized that these medications were not.

This issue ⁇ deserves the attention of our Parliament.

First of all, of course, I would like to thank the reporter for his good report and his praiseful contribution to the debate.

Colleagues, drug counterfeiting, I don’t have to tell you, is actually the worst and most immoral form of counterfeiting. It is becoming an ever-growing plague in many countries with dangers to the health and even the lives of many people. Mainly in developing countries, drugs circulate without an active ingredient or even toxic. The drugs, colleagues, which are most fake are those against potentially deadly diseases such as malaria, tuberculosis and HIV-AIDS. The consequences are terrible.

Everyone of you, of course, knows fake goods such as handbags, t-shirts that we, if we go on shipping or travel, buy on local markets at far too low prices. We know that the products are not real. The WTO has rightly launched the struggle against this kind of counterfeiting, but it is of course much worse when it comes to counterfeiting medicines because then it is of course a struggle of life on death. Bringing a fake medicine on the market is really playing with the lives of thousands of people. Hundreds of thousands of people – and that’s what it’s about, don’t think we’re exaggerating here – are deliberately misled. They pay a lot of money for a medicine that they hope can save their child’s life. The distraction – which I don’t have to tell you – they feel when it turns out that the drug doesn’t work because the information is misleading or the ingredients are toxic.

Colleagues, we have seen natural disasters or gas explosions here in Belgium, but also in Haiti in recent weeks. We also know about the tsunami. Great disasters that we can do very little about. But against this plague that affects so many people, we can do something. I therefore call on all of you to read the resolution thoroughly today and then vote with all your heart. I will give you a few figures. The World Health Organization estimates that 200,000 people die annually from malaria because the medicines they take are counterfeit or of poor quality. That’s one-fifth of the total number of people who die from the disease. In China alone, more than 190,000 people per year would die from the effects of these counterfeit medicines. In Cameroon and six other African countries, the World Health Organization says, as much as 70% of the funds, which claim to cure malaria, are counterfeit. In the least developed countries, at least a quarter of medicines are counterfeit, and sometimes more than half.

Colleagues, how much hope is grounded when people who use counterfeit drugs? I find it unacceptable. You remain silent with it, but in me it is cooking. I find this really unacceptable. Who can’t imagine a mother mourning for her dying child while buying medicines with the last penny she had? Imagine what an upheaval that would make if such a case occurred in Belgium or in Europe. Imagine a child dying because the medication does not contain the means read on the label. Can you imagine what a mediaheisa would cause such a thing?

Colleagues, in developing countries this happens every day, without anyone standing on the barricades. That is the reality. We want to give a signal against this. We should not remain on the side line. We must stand up for the rights of poor people who sometimes buy medicines with their last money that then prove to be fake.

We must take action through our development cooperation. With our development cooperation – you know that all, colleague De Croo knows that very well, because he has visited many projects – we very often support capacity building. We help countries build their own structures. With this resolution, we call for the establishment of a control mechanism when building those capacities, enabling the control of those medicines. I think this is absolutely necessary.

I believe that we should also assist governments in regulating and monitoring the quality of medicinal products in their own territory. The services sometimes exist, but are unfortunately susceptible to corruption. We should not allow projects we support in those countries – we give, rightly, a lot of money to support healthcare in developing countries – to use counterfeit medicines. We must ensure that the quality of the medicines used in our projects is always guaranteed.

An additional problem is that a lot of these products are made elsewhere, but the African developing countries reach after a transit within Europe. There too, we have another stick behind the door, by ensuring that we can control the quality so that the medicines never get on the market.

Colleagues, I hope that some people have listened here and are aware of the big problem. Sometimes I feel like someone stands here crying in the desert. This is often felt by people in developing countries. I would like to ask you to once again unanimously approve the resolution with full conviction and to assist the Minister of Development Cooperation so that it is implemented and so that we at least try to halt a part of the trade in counterfeit medicines.

Thank you to those who listened attentively.

Mrs Vautmans, Mr De Croo would like to interrupt you for a moment.

Mr. Speaker, I agree with the unanimity of the House on the initiative of Hilde Vautmans.

However, she took another initiative, which was wider. This is in particular the control of the implementation of resolutions.

We have now become a kind of questioning and resolving Parliament. However, it seems to me essential that, for example, the monitoring of what the government does with the resolutions is followed, and that Parliament receives a report on this. In the other case, of course, it is bidding the mountain up.

Mr. Speaker, it is good that a resolution such as the resolution presented today is being discussed.

I would also like to give a signal. I have already given a signal to the pharmaceutical industry. I would like to send a signal now again, especially to companies participating in actions I once experienced myself that companies gave out expiration products, because they have to process them here, which costs money. They simply gave the products, to distribute them to the population on the spot. I really thought I couldn’t.

Therefore, we must give the above as a signal.

( ... ) The follow-up of resolutions.

The follow-up of the resolution is therefore very important.

Mr. Minister of Justice, Mr. De Croo has asked an important question. All resolutions that we accept here are not here approved with the intention of classifying or storing them.

In one of the coming days, I will call on the government, which you represent here, to give a stand-up and report on how and to what extent the government follows and respects the proposals that the Parliament approves. (Applause of Applause)

I do not doubt your respect, but it will nevertheless also have to be shown in the way the resolutions are implemented.

Mr. Speaker, on the latter point, I would like to draw everyone’s attention to the fact that the House has a committee that continuously follows what happens in the government with the resolutions. In other words, we can take an initiative in this area too. I’ll also bear what you bring forward.

On the present proposal, I would only want to lose the following.

Mrs. Vautmans does not have to worry. She was not the vox clamantis in deserto. At least I listened attentively and I totally agree with her. However, I would like to remind you of what I have stated in the committee. The products referred to, which indeed very often lead to serious abuses, are mostly manufactured in third world countries, over which we have no control, Mrs. Detiège. I dare to refer to what is happening in Southeast Asia.

The [...]

No, I thought you were protesting against my claim.

I can assure you that in Southeast Asia, on all ordinary markets, most of our medicines are found, beautifully replicated.

The [...]

I don’t want to question your professional qualities, but a fellow like me can’t see the difference. So simple is it.

The only thing that makes one suspect it is a fraud is the price. I remember visiting a pharmacy in Phnom Penh — a real, classical pharmacy, a Western pharmacy as it were — where aspirin was sold one by one because that drug, which is not more expensive there than it is with us, on the contrary, is very expensive for the people.

On the market in that city — I even remember the name of that market, the Russian market — one could buy aspirin which was ten times cheaper. It was not aspirin. We were told there in Cambodia that these products mostly come from Vietnam. I did not check this. It does not fit well between Cambodians and Vietnamese. Therefore, I am not sure of the objectivity of what was communicated to me there. In any case, it happens gender often, and even in Africa it happens.

However, this is not a reason for me not to approve the proposal of Ms. Vautmans, on the contrary.

Mr. President, since Mr. Van den Eynde addressed me, I wanted to respond.

Many medicines are produced in these countries. All medicines that arrive in Europe must meet the European criteria, regardless of where they are manufactured. They are normally tested. There are analyses.

The problem arises in the developing countries themselves, where they do not have that capacity. We have to hammer on that.

As for Europe, you also know that the Internet circuit is very difficult to deal with. Therefore, on 5 February, at the Benelux level, we want to jointly examine how this can be addressed internationally. Mr. Van Campenhout is also in this working group.

Mr. Speaker, I did not want to compromise Mrs. Detiège and I fully agree with what she said.

I just wanted to tell Mr. President. Van den Eynde said his argument did not hold the way, as we are increasingly working with governments on local regulations and on quality control capabilities. I myself have been involved in such programs. Checks are carried out in pharmacies – and I know those in Phnom Penh well. This is a mission that is accomplished with the help of the government. This is why we are able to help you create legislation and control bodies that can act in this area.

This problem is extremely serious. Therefore, it would be a very bad signal to pretext the local origin of these drugs to not intervene. First, most of them are produced in Europe and some transit through Belgium. Finally, for those that are produced on site, we are working on control and insurance programs, which absolutely need to be strengthened.

Mr. Speaker, colleagues, our group, of course, supports Mr. Vautmans’ resolution on access to essential medicines in developing countries. In fact, one cannot be opposed to the Belgian government being asked, and I quote, to “support regulation on the quality of medicines, vaccines and other small medical equipment intended for export”, nor to the fact that those medicines “must meet the same quality criteria as those intended for the single European market.”

So-called counterfeit medicines are indeed a major threat to development cooperation. We just heard this in a striking way from colleague Vautmans. They also carry a very large responsibility to policy makers, international aid organisations and NGOs. Such drugs can potentially harm the health of millions of people. The number of medicines purchased annually within the framework of development cooperation for all African countries alone is enormous and represents a very important market. This often involves millions of dollars per country and per year. The purchase price for malaria medicines in a relatively small country, such as African Niger, with just 10 million people and a seasonal form of malaria, fluctuated around $1 million per year in 2007 and 2008. That was then only through funds for one year, from a single donor, the Global Fund to Fight AIDS, Tuberculosis and Malaria.

False medicines carry huge risks. A notorious example in Africa is the fake vaccine against meningitis, which was massively administered in the same Niger as part of a humanitarian gift in 1995, during an epidemic. Not less than 2,500 deaths, mostly children, were the result. So the idea that in the best case, fake drugs simply don’t work because they ⁇ ’t contain the necessary ingredients is not true. A malaria medication that doesn’t work will allow the fever to break through and the disease reaches the deadly stage. A fake AIDS antagonist will allow the patient to no longer be protected and again become vulnerable to fatal infections. A small percentage of the fake medicines are even purely toxic and cause more harm than it would have a therapeutic effect. As early as 2006, a survey of ⁇ cases in the World Health Organization database found that 60% of the counterfeit medicines contained no active ingredient, 17% did not have the correct dose and 16% was actually a wrong medication. Only 7% was an acceptable copy.

I would like to comment on the relevance of this resolution. In terms of content, the text was allowed to weigh a little more, not only because the questions to the Belgian government remain rather vague, as I have also said in the committee, but also because the scope and consequences of the requested appear to be underestimated.

For example, when the questions to the government are asked to advocate in the European context for a regulation on the quality of medicines, vaccines and other medical equipment, it is ignored that a very large part of the medicines, especially the generic medicines used in development cooperation, are currently produced in countries such as India and China, including European companies there. Thus, these medicines do not pass through Europe when purchased for projects in Sub-Saharan Africa and Asia. Therefore, advocating for a European union will not be enough, although it is a good attempt.

The second question states that the policy, which should be based on strengthening the administrative capacity of developing countries, should focus on the expansion of the national control and inspection bodies in terms of the quality of medicines in our partner countries. It should be advocated that they apply the standards of the WMO. This is, of course, a very defensive question, but it completely transcends the reality on the ground. This question covers a huge load. Expanding the control and inspection bodies within our partner countries to the criteria of the World Health Organization and therefore of the international standard is a huge challenge. In fact, it includes the construction and/or renovation of laboratories and scientific institutes, the training and training of laborers and scientists and skilled medical personnel, the avoidance of a brain-train that causes those newly trained people to try their happiness elsewhere, the creation of an efficient administration that provides laborers and medical personnel with a working structure and a decent salary, the training of both doctors and nurses and other staff to judgefully deal with potentially dangerous medicines, the development of facilities and infrastructure for the storage of medicines and medical equipment that benefit a rational use, an internal transport network that ensures that the right medicines arrive at the right place, resisting corruption and political pressure to work with local producers for example for the purchase and import of medicines. All these are huge challenges. However, in various countries of Sub-Saharan Africa, the technical capacity or local know-how, for various reasons, is currently often so low that national laboratories are not able to test even certain basic medicines.

For example, some AIDS inhibitors are so complex and new that only three to four laboratories worldwide are able to perform a closing test.

Finally, it is also requested to ensure that medicines, vaccines and other small medical equipment purchased within the framework of projects or programs supported by the Belgian Development Cooperation meet the generally accepted international quality standards and that the necessary resources are provided for this purpose. This too is, of course, a very noble endeavor of the authors, but also here one must dare to be much more specific. According to the Minister of Development Cooperation, the resources released by our country within the framework of the fight against infectious diseases such as HIV/AIDS and malaria, mainly go to organizations such as UNDP, Unicef, WHO, UNAIDS and The Global Fund to Fight AIDS, Tuberculosis and Malaria. This makes the last paragraph quite unnecessary. These organizations and donors already work with the strictest quality standards. An organization such as UNICEF goes even so far that it works with a limited number of producers who must meet the highest standards in terms of quality and price, and with its own distribution system.

However, we seem to need a greater control – which has already been cited by colleague Van den Eynde – also for medicines and medical equipment purchased through Belgian development aid, but that does not fall within the aforementioned international partner organizations. At this point, it seems to us that there is still some room for a new resolution and for new legislative work. We will be very happy to work with our colleagues from Open VLD. In any case, it is a good attempt.

I agree with the positive news. There was no talk here in the desert. The message is made clear. I do not have much experience from the Justice Department with resolutions made in the matter, so I do not know how colleagues deal with them. Of course, if you provide me with the inventory of the resolutions, which will be delivered with great pleasure to the government and will request that you pay the necessary attention to them.

I feel that Parliament is a little underestimating its own power in regards to the supervision and control of the ministers. I have experience with that. If Parliament wishes to pay attention to this, it has all the means to control the ministers in the implementation, including of the resolutions adopted by Parliament. I will with great pleasure forward the message to the Government and to the competent ministers.

I feel like this is the second time that the Minister of Justice claims not to know the resolutions on justice. I ask the Chairperson of the Committee on Justice to put on the agenda of the committee next week a resolution that I drafted with Mrs De Schamphelaere following our trip to Canada. I will be happy to come and talk to you about my decision.

Hats for the strapers. They are the best forest guards. We will fully monitor this.