Proposition 51K1348

Projet de loi modifiant la loi du 28 mars 1984 sur les brevets d'invention, en ce qui concerne la brevetabilité des inventions biotechnologiques.

General information ¶

Submitted by

PS | SP MR Open Vld Vooruit Purple Ⅰ

Submission date

Sept. 21, 2004

Official page

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Status

Adopted

Requirement

Simple

Subjects

EC Directive bio-ethics biotechnology intellectual property patent law invention

Voting ¶

Voted to adopt

CD&V Vooruit PS | SP Open Vld N-VA MR FN VB

Voted to reject

Ecolo

Abstained from voting

LE

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Discussion ¶

March 10, 2005 | Plenary session (Chamber of representatives)

Full source

Mr. President, Mr. Minister, colleagues, the committee discussed the bill and the attached bill by Mr. Monfils during the meetings of 23 November 2004 and 1 March 2005.

On 23 November, a series of hearings were held with a number of stakeholders, including Belgo Biotech, Pharma.be, the Centre de Génétique Humaine of the UCL, the Flemish League Against Cancer, the Center for Intellectual Rights of the KUL and the R&D section of the KUL. A consultation was also requested from the Public Health Committee.

What is the design about? The proposal aims to transpose Directive 48/44/EC of the European Parliament on the legal protection of biotechnological inventions and to align the Belgian Patent Act of 28 March 1984 with it.

Everyone knows that biotechnology is one of the most important key sectors for the 21st century. It is important for the field of human and animal pharmacy, especially vaccines, enzymes, and agro-nutrition. Biotechnological inventions are inventions concerning a product consisting of or containing biological material, or concerning a process by which biological material is obtained, processed or used. These are, of course, high-risk investments and it is therefore appropriate that there is protection under patent law in order to encourage investments in research and development and to preserve the competitive position of the European Community.

The debate on this directive has taken place in Europe for more than 10 years. With us in the committee it was a little shorter.

The aim is, of course, to seek a balance between the protection of the inventions, on the one hand, and the view that every living material is part of the human heritage, on the other. It is therefore important to ensure innovation and scientific research, but also to ensure that the intangible ethical rules and principles are respected. In fact, the Directive contains provisions concerning respect for principles guaranteeing the integrity and dignity of the person. Therefore, according to the draft, not patentable are: the methods for cloning humans, the methods for modifying the germinal genetic identity of humans, the use of human embryos for industrial or commercial purposes, and the methods for modifying the genetic identity of animals suitable to cause them to suffer without significant medical benefit. This list is of course not limiting.

Likewise, plant and animal varieties shall not be patented and an invention relating to plants or animals shall be patented only if the technical feasibility of that invention is not limited to a particular plant or animal breed.

Patents are not new. One of the first patents granted happened to Louis Pasteur for pure yeast. This has been going on for a while now. The first patent dates from 1873. The protection of biotechnological inventions is therefore not new. However, in recent years, this practice has become increasingly important thanks to the spectacular progress in the development of new techniques for gene manipulation in the pharmaceutical industry.

Following several discussions with the public and interested sectors, the Council of Ministers applied the following principles in transposing the Directive.

First, the submission of patentability to the principle of the non-property nature of the human body.

Second, the clarification of patentability of parts of the human body.

Third, the indication in the patent application of the geographical origin of the biological material of plant or animal origin. Fourth, the possibility of granting a compulsory license in the interest of public health.

It is important to note that Belgium has already been convicted for failing to fulfill its obligation to transpose this Directive.

A lot of hearings were held. I will give a short summary because some elements come back in the general discussion.

The hearings gave the word to representatives of BelgoBiotech and Pharma.be who expressed concerns about the need to indicate the geographical origin if known. They also expressed concerns regarding the research exemption that allows research with and on the patented invention for scientific purposes and on the granting of compulsory licenses in the interest of public health. Both BelgoBiotech and Pharma.be emphasized the importance of the pharmaceutical sector in general and the biotech sector in particular for our country.

As part of the hearings, Professor Verellen spoke on behalf of the centers for human heritage in our country. He emphasized the importance of genetic testing in people belonging to a family often affected by the same disease and for the detection of risk cases so that the necessary prevention can be done. Professor Verellen saw compulsory licensing as a golden middleway between granting patents and diagnostic requirements.

As part of the hearings, Professor Matthijs spoke on behalf of the Flemish League against Cancer. He stood silent on the Myriad affair where patent legislation provided a monopoly on genetic testing for breast cancer in which the patient became the victim. He held a fierce plea for the compulsory licensing procedure as provided by law.

As part of the hearings, the committee heard Professor Van Overwalle of the KUL who called for a clarification of the research exemptions in the law and a refinement of the system of compulsory licenses. Basically, she believed that the legislature had achieved a good balance between the interests of inventors and investors on the one hand and the interests of indigenous peoples, patients, consumers and researchers on the other.

Finally, Professor Debackere of the KUL called for a revision of the research exemption and a refinement of the compulsory licensing procedure to counter abuse.

In the general discussion, a number of elements were discussed, of which I briefly wish to emphasize the main because they were at the heart of the discussion in the Committee on Business.

First, the explicit consent of the donor is not included in the law. Several members have intervened on this point. According to the Minister, this is an important data but this point needs to be regulated in the Law on Patient Rights.

A second element that focused on the general discussion was the patentability of an ex vivo gene.

This discussion was finally resolved after ten years at European level by making a distinction between the patentability of an ex vivo gene and the non-patentability in vivo.

A third element of discussion was the famous research exemption. There was a plea for clarification of that term in the narrow or broad sense. Finally, the Minister confirmed that the interpretation must indeed be made in a broad sense, thus that it applies to acts with purely scientific purposes as well as to acts with mixed scientific-commercial research. These are acts both on and with the patented invention.

A fourth element that was important in the discussion was the mention of the geographical origin, if known. It was clarified that this is a formal requirement and not an additional investigation obligation, taking into account the TRIPs Agreements and the Rio Convention.

The fifth element was of course the big debate around the compulsory license itself. This was also clarified after discussion through an amendment. Finally, it was clarified that it is a special regime; that it is based on Articles 30 and 8 of the TRIPs Convention and the Ministerial Declaration of Doha of 2001; that it is done in the interest of public health, for example when products, processes or diagnostic methods are not sufficiently available or are of insufficient quality or are offered at overpriced prices.

It was also clarified that the right of initiation belongs to anyone who has the necessary resources to carry out manufacture or application in Belgium.

It was clarified that the advisory authority for the assessment of the validity of the compulsory license was entrusted to the Bioethics Advisory Committee, which for that purpose is an independent body capable of formulating an expert opinion. The patent holder will be informed of the license application and deadlines will be attached to the entire procedure. After all, it is individual licenses and the license will be granted by the King by a decision consulted in the Council of Ministers that will grant the license and will determine certain conditions related to remuneration, duration and scope and that will also include the time of the procedure of award.

It will also be possible to appeal to the court against the compulsory license.

In addition, the accelerated procedure is also integrated, possibly in the event of a public health crisis.

Finally, measures were also registered to prevent abuse of the compulsory license.

A very final element was then the discussion on the production of medicinal products under compulsory licensing for export to countries with public health problems that have no or insufficient production capacity in the pharmaceutical sector. In this regard, the Minister announced that there is a European regulation in the pipeline that becomes immediately applicable in Belgian law. Two-week meetings are currently held at European level. There is also an accelerated procedure.

Mr. Speaker, Mr. Minister, these were the main elements of the discussion.

After a thorough and substantially very interesting discussion in our committee, the present draft was unanimously adopted by all members of the committee.

The following problem arises now.

For technical reasons, it is advisable to suspend it after 19.15. The catering is not finished yet. If that can involve a summary of the discussion, without weighing on any time span, I would now like to start with the general discussion, hoping to close the afternoon meeting around 19.30 and to begin 45 minutes later with the evening meeting.

This applies to everyone.

I had a problem with mr. Duquesne in time.

As stated in the bill at the beginning, the biotechnology sector is one of the key sectors for the economy of the twenty-first century. For Belgium, it is ⁇ one of the key sectors for achieving the Lisbon targets. Biotechnology is also no longer to be burned away from our daily lives: transgenic tomato puree, pigs as organ banks, medicines from rabbits, and so on.

Biotechnology uses living organisms. The patent law should provide protection for biotechnology results. Patent law of biotechnological inventions was and is the subject of discussion. Among them is the discussion of genetic patents.

It was important to design an appropriate legal framework for biotechnological inventions. Europe has been around ten years. The long debates and strength measurements were finally settled in 1998 by a European directive. Belgium abstained in the vote on the directive. The Directive had to be transposed into Belgian legislation at the end of July 2000. Since this has not happened, Belgium was condemned by Europe and we now have coercive fines over our heads.

Mr. Minister, now some correction to the bill in this plenary session may not be liked by you, given the urgency.

Minister Verwilghen’s bill is not the first bill. As a member of Parliament, I had the opportunity to participate in its entire development. It began with the then Minister of Economy, Elio Di Rupo, who provided for a first preliminary draft law. The first preliminary draft law came to light on 29 October 1998. Following a government change, Minister Rudy Demotte was given the responsibility. He organized a large-scale public debate on the patenting of biotechnological inventions. However, Minister Demotte forgot to allow legislative work to follow up. With Minister Picqué, a second bill was drawn up. A lot of advice was asked. However, due to the opposite nature of the many opinions, the bill was left by Minister Picqué but for what it was. Minister Moerman took the thread again, but was succeeded after one year by Minister Verwilghen who continued the work.

Minister Verwilghen’s bill is a fairly faithful transposition of the European directive, although we would like to emphasize that the European directive itself still leads to fierce controversy today, among other things about the difference between discovery and invention in the field of human genetic technology. The draft law deviates from the European directive on two points: one, the examination exception, article 11 of the draft and two, the compulsory license, article 13 of the draft. The debate was mainly on the derogations from the EC Directive.

What is the Research Exception? It follows that the rights arising from a patent do not extend to acts performed on and/or with the object of the patented inventions for scientific purposes. Both the biotechnology companies, the pharmaceutical industry and the research institutions considered this provision too broad. Especially the terminology "scientific research" was in their eyes much too wide. What is Scientific Research? Is it pure scientific research? Is the scientific research that ultimately ends up in commercial exploitation? Their

CD&V wanted to remove this article and we wanted to fix this through other legislative work. The Minister then made a statement with clarifications regarding Article 11, and we could eventually agree to that. The term "for scientific purposes" is indeed subject to multiple interpretations. It is not clear whether research conducted in commercial companies or only research conducted in academic institutions falls under the research exemption. From the text of the draft law, nor from the memory of explanation, it can be deduced whether a narrow interpretation, purely scientific research aimed at increasing understanding and testing a hypothesis and so on, or a broad interpretation, mixed scientific research aimed at developing new applications, improved therapeutic effect, more efficient production method, and so on, of the notion of scientific commercial research is intended.

Furthermore, the proposed provision leads to a restriction of patent protection which, according to Biotec and the VIB, will result in inventors keeping their invention secret rather than making it public through a patent application. After all, today the research exemption in most cases is interpreted narrowly. Acts performed on the object of the invention may be, for example, acts for the purpose of testing, but acts with the object of the invention, therefore where the patented invention is used as a means of research, cannot. In practice, however, there is a dough situation in which patent holders will not pursue academic research exemptions or only in exceptional cases. The draft law now regularizes this dog situation, but this in practice threatens to result in inventors keeping their invention secret more often.

Colleagues, in the end, the statement of the minister has put the points on the i and is actually, instead of the clarification in the Memory of Explanation and instead of in the law, now clearly stated what should ultimately be understood under Article 11.

Then the mandatory license. Here we enter the area of the delicate relationship between patents and public health. The Belgian legislature aims to prevent patents on biological material of human origin from hindering access to good and efficient health care. That provision was undoubtedly motivated by the Myriad Genetics case, in which that company acquired, by means of patents on certain breast cancer genes, an exclusive right to screen these genes for anomalies and demanded high fees for this. Their

During the hearings, we learned that some fear that the compulsory license will lead to abuse and that the procedure will degenerate in an arena where companies will compete with each other. One of the abuses could indeed be that one company attacks the devil on another in the struggle for the patent. Others were strong supporters of the compulsory license, but called for an improvement and refinement of the law. We also submitted an amendment to refine the whole. The Minister also submitted an amendment by a majority, which refined the procedure for initiating the application for a compulsory license.

It should be clear that we are for the introduction of a compulsory license in the framework of Public Health. Abuse must be prevented. Therefore, in our amendment we have incorporated thresholds for the granting, withdrawal and modification of the compulsory license granted pursuant to a decision adopted after consultation in the Council of Ministers on the proposal of the Ministers of Economy, Public Health and Social Affairs. In our amendment, we have added the Minister of Social Affairs, as the question of budgetary costs of the essential refunds accompanied by a compulsory license, such as in the case of genetic testing, must also be taken into account.

In our amendment we defended a committee of experts instead of the Committee on Bioethics, not that we have questions about the competence of the Committee on Bioethics, but we believe that in addition to experts on ethical aspects, there are also experts on intellectual property rights, Public Health, Economy and Trade when asking for the granting of a compulsory license.

In our amendment, we also provided for a vocational possibility. As previously stated, the Minister himself, through the majority, submitted an amendment to Article 13, which included most of our amendment. Thresholds were built in, so that it could not be taken too quickly for a compulsory license.

We agree, but we regret that the applicant for a compulsory license does not have to prove that he has already sat at the table with the patent holder or that he has attempted to consult with the patent holder. Therefore, there are still risks of abuse. Minister, we regret this. On the one hand, we increase thresholds, but on the other hand, it is a threshold-lowering measure. We supported the need to first demonstrate that there had been consultation between the applicant for a compulsory license and the patent holder.

The Conclusion . The draft law seeks to find a delicate balance between the interests of inventors-investors, who demand effective protection of their invention, the interests of consumers and patients, who want accessible health care, and the interests of researchers, who demand a fair opportunity for research. Although not everyone will be satisfied, we will approve this bill.

Mr. Speaker, dear colleagues, I would like to thank and congratulate the rapporteur for his excellent work, especially since this is an extremely technical and, it must be said, very little media subject.

Mr. Speaker, as you said in your preface, some debates do not always receive, from the opinion leaders, all the attention they deserve.

Recognize some experience in the head of the President!

A few days ago, you actually said what it was! I congratulate you!

The text that is presented to us today is extremely important. I will briefly cite a few figures dating from about ten years ago. Already in 1996, the field of biotechnology was 6.5 billion euros in the United States but it was 650 million in Europe, or ten times less. Income was 10 billion euros in the United States and 1 billion in Europe. The biotechnology product market was 100-150 billion euros from 2002-2003, with a quarter for medicines. And on the grey matter side, there are ten times more researchers in the United States than in our country.

The problem is not only economic. The problem is with what medicines we will treat ourselves in two, three or four years. Will it only be with medicines from Japan or the United States or will Europe still have the control over its own health?

Those who say “patents, economic choices” are completely wrong. It is a public health problem, it is our health, to us Europeans, which is fundamental, independent of, of course, economic development and high-level research.

This is the reason why the directive was approved, in 1998, after much work with a massive vote: 380 for, 110 against, 15 abstentions, or 75% of "yes". It’s better than our fateful two-thirds that have taken care of us for decades!

I will not epilogue on the definitions, and in particular on Articles 3 and 5 of the Directive, because we do not have time to do so. I would simply say that it is there and that it is imperative. For years, we have been discussing the definition and what is patented. Of course, it is necessary to comply with the directive.

Our project translates this. As always, we want to be more Catholic than the Pope. As always, we want to go beyond the directive, as we did in the ban on tobacco advertising and the Francorchamps problem, as we did, Mr. Minister, in the field of copyright in relation to computers!

In fact, without Article 13, Mr. Minister, your project, you would have had it not in 48 minutes but in two or three meetings. But there was Article 13, which was not covered by the directive. What does Article 13 say? “In the interest of public health, the Minister can completely change the patent system and therefore can take a number of derogatory measures, in the interest of public health or in the event of a public health crisis.” There is no definition of what “public health interest” is. It does not define what the “public health crisis” is. It is also not said that it is necessary to first seek the opinion of the patent holder regarding its possible industrial exploitation. Nor is there any guarantee regarding the company that would eventually commit to exploiting the patent, since it must have the loyal intention to obtain the means. I like to tell you that in business as well as in politics, the loyal intention of obtaining the means of something is never but a chocolate guarantee.

Finally, the guards are few: the Council of Ministers and the Bioethics Committee. The problem is that the directive did not say anything about all this. It simply contented itself, in a single article, to deal with the right to obtain vegetable, which is really only a detail, because it is about obtaining the possibility of exploiting a patent in the first line when one is in the second line.

The TRIPS Agreement on Intellectual Property Rights allows exceptions to patent rights, but under very specific conditions. There must be an application before use, there must be circumstances of extreme urgency, in short, a whole series of elements that make that only in extremely special cases, the traditional system can be challenged, i.e. patent holder, applicant for use of the patent.

Thus, in some cases, public authorities can do so, but in the present case, all these restrictions have obviously not been taken into account in the original text. After mature reflection and long deliberations, the minister still agreed to amend Article 13 on a single point. I am happy to acknowledge that an effort has been made. There are deadlines and the holder of the patent must be informed. This is not to negotiate with him or ask him if he does not agree to give up his patent. It also speaks of the obligation to set a reasonable remuneration.

I recall that the minister referred to the French law, but that the latter is much stricter, because it speaks of the interest of public health, but defined by a whole series of conditions and because, in order to decide on a mandatory license, one must first question the interested party, hear his refusal, wait for a certain time. Only then can the patent be placed on the market.

Finally, Article 13 allows the minister, who became a co-contractor, to question the right of patents and say: "If you do not pass my conditions, I remove you the possibility of exploiting the patent and I give it to whom I want." Unquestionably, this is a considerable extension that I do not like very much. I will quickly address another problem on which, this time, Mr. Minister, we agree: the problem of the distinction between somatic therapy and germinal therapy. The European Directive does not accept research in germinal therapy. Everyone considers that this is a case that dates back more than a decade ago, that things have evolved, that now it is possible to conduct research to combat genetic diseases related to offspring. Indeed, if there is no question of accepting germinal therapy of improvement, like the blonde with blue eyes; on the contrary, it is quite acceptable to correct genetic diseases concerning the offspring.

We discussed this and the Minister agreed to ask the question to the European Commission to see to what extent it could accept this interpretation, this dichotomy: no to improvement therapy, yes to correction therapy.

I speak of it all the more easily as I found, not later than yesterday, in a vote at the UN on human cloning, that Belgium has very justly issued comments on the subject, submitted amendments to allow non-reproductive but therapeutic cloning, that it has almost seen its amendment accepted, that it voted against the resolution, which for me is unacceptable. We are also in good company since France, Great Britain, Luxembourg, all the scientifically advanced countries voted against accusing this resolution of being a madness. This resolution is not binding, as you know, and I congratulate the government representative who really translated the position of parliamentarians, the law that was voted and the position that was determined in this hall.

In conclusion, Mr. Speaker, we are late: we need to vote on this directive. I regret somewhat the white-seeking given to the minister in patent law: it is contrary to the spirit of the directive and it is contrary to the TRIPS agreements. Even amended, the text may allow abuses; it may set the milestones for a risk of ideological debates about the meaning of the patent, which I would obviously not want.

Mr. Minister, you will agree with me: it is necessary to avoid any decisive measure leading to the closure of ⁇ and the leakage of the brains that would estimate that the Belgian system is a source of economic uncertainty. Biotechnology is a future industry. We have extremely brilliant researchers; let’s not waste our chances.

That is why, even if you speak concisely, I will wait for you to reassure us on this point.

Mr. Speaker, Mr. Minister, the reporter, Mrs. Creyf and Mr. Monfils have already delivered substantial speeches. I will not fall into repetition and leave room for the next speakers. I will be short.

The draft law implies the faithful transposition of a European directive. Therefore, it does not affect the provisions of other already existing treaties. However, it goes beyond the mere transposition of the Directive.

Biotechnological inventions are generally patented. However, the draft provides for an exclusion. The rights arising from a patent shall not extend to acts performed for scientific purposes. Scientific objectives should be seen in a broad sense. The previous speakers spoke extensively about this.

For the sake of public health, compulsory licenses may be granted. We are pleased that a new Article 31bis, on which we have collaborated, will provide some legal certainty, both for industry and for public health.

The draft law had to make a difficult exercise. It was to reconcile the importance of patents for business with ethical considerations regarding the patentability of living material. This has also succeeded.

Of course, the interests of scientific research must also be taken into account. In itself, patentability is responsible. It really has to be about inventions. They must be new and non-evident. They must therefore meet strict criteria.

With the ethical considerations, this draft takes into account inventions that are contrary to public order and good morals. There are also other exceptions. For the benefit of public health, compulsory licenses are possible.

The Conclusion . At the same time, the bill provides a legally secure framework for the patentability of biotechnological inventions and does not compromise the ethical principles in which this system should be embedded. It is a middle-of-the-road solution. That is why our group will also support it.

Mr. Speaker, I will be very brief on this matter. Monfils has already highlighted a number of things.

From a general point of view, some articles of the directive pose problems for us. Ms Gerkens has also submitted an amendment.

The definitions in Article 4 may raise questions. According to the new article 4, §6, "a isolated element of the human body or otherwise produced by a technical process, including the partial sequence of a gene, may constitute a patentable invention even if the structure of that element is identical to that of a natural element."

Furthermore, I would like to recall that Belgium has already been convicted by the Court of Justice for not transposing this Directive. In my opinion, our country must play the game of the European Union and transpose the text correctly and as faithfully as possible. This is an obligation of international law from which we cannot derogate.

In addition, as Mr. As Monfils said recently, some articles go beyond the simple transposition of the text. I would like to return to two articles.

Article 11 refers to a new concept of exceptions for scientific purposes. I fear that this new notion, advanced in the text, gives rise to new interpretations. Why have we not kept the notion of "act performed on experimental basis" which relates to the subject of the patented invention? It seems to me that it would have been better to keep the notion as it appeared in the previous text.

Another note concerns Article 13 and the new procedure incorporated in Article 31a. I am afraid that this procedure does not provide sufficient guarantees for the granting of mandatory licenses. by Mr. Monfils spoke of the concept of public health that could give rise to a number of interpretations. I fear that proceedings are initiated for purely abusive purposes. But I hope that this will not be the case. It is still true that Article 13, as inserted in the project and as it modifies the current system, risks to have disastrous consequences.

It is primarily because of our comments on these articles that we will abstain from voting on this draft.

Mr. Speaker, Mr. Minister, colleagues, we have actually always said, from the beginning of the discussion of this draft, that we actually fundamentally agreed with one of the speakers during the hearing, namely with Mr. Gert Matthijs — who spoke on behalf of the Flemish League against Cancer — at the time when he said that he actually had a principled objection to the idea that patents were possible on genes and genetic tests. His premise was that a gene is not an invention and that the relationship between a defect in a gene and an inherited disorder is actually a given from nature. This led to his reasoning that patents on genes and on genetic testing are actually an irresponsible monopoly. One simply cannot develop a better or newer diagnostic method without access to patented DNA sequences.

The genetic code is indeed unique and that is contrary to the purpose of a patent to challenge a competitor to find something better. You cannot find anything better, because a gene is a gene. This is a given of nature. In fact, we agree with his principled stance, but we have lost that battle, even in Europe. The European Directive eventually compromised that a gene in vivo is not patented, but an ex vivo gene — from the human body — is indeed patented and patented.

That being said, we have seen the problem of Myriad, which has voted for us all very vigilantly. Myriad Genetics patented two flawless breast cancer genes in breast tissue, which immediately gave them the exclusive right to screen for abnormalities. This meant that the patent holder, Myriad, refused to license hospitals that use stamped kits for cancer detection. This undermined our screening for hereditary breast cancer in our centers for human heredity. Where those tests could be done at an affordable price, patients were now required by Myriad that all DNA tests in their laboratories in the United States should be done at 2.500 euros per test.

Eventually, the battle against Myriad was settled by the European Patent Office. Indeed, the European Patent Office broke Myriad’s case, but it is not insignificant to see that the European Patent Office broke it on formal grounds. Of course, they do not comment on the basis of whether genes are anyway patentable or not. They have stated on formal grounds that Myriad still retains the exclusive right to two specific diagnostic techniques, but that all other forms of diagnosis are indeed free so that our centers can continue to work. In fact, it was only on formal grounds. Therefore, we were very concerned that the problem of compulsory licenses and compulsory licenses in the interests of public health would indeed find a place in this law. We are therefore very pleased that the patent law, as written in our draft, is clearly limited in the interest of public health.

We should never remember what happened to the South African government at the time when it wanted to consider cheap generic AIDS inhibitors from India and when it was sued in court, both by the American and European pharmaceutical companies.

Ultimately, the government in Pretoria was right, because the judge ruled that people should not be deprived of affordable medicines by patents.

For us, three elements were crucial in the present design. First, the patentation as presented here should not constitute an obstacle to scientific research. Secondly, forced licensing should be possible in the interests of public health and the Ministers of Health and Economy had to take their responsibilities together. Third, compulsory licensing should also be possible in the context of the production of medicinal products for export to third-world countries that have no or insufficient own production capacity and yet face serious health problems.

First, regarding the guarantee that it would not be an obstacle to scientific research, we have gained clarity thanks to the statement of the Minister who said that the phrase section for scientific purposes should indeed be understood very broadly. The fact that both scientific research and mixed scientific-commercial research fall under this denominator is happy to us.

Second, the possibility of compulsory licensing is now clearly included in the law, with a good balance between the Ministers of Health and Economic Affairs and with the opinion of the Bioethics Advisory Committee, which guarantees the rights of the patient. The fact that diagnostic tests also fall within the procedure is a good thing for us. So we have satisfaction with regard to the second element. Third, as regards the use of the compulsory license for the export of medicinal products to third world countries, thanks to the law, the accelerated procedure is possible in the event of a public health crisis. The Minister announced that today in the European Council of Ministers the final hand will be put on a proposal for a regulation on the granting of compulsory licences for pharmaceutical products intended for export to countries with public health problems and with insufficient or no own production capacity. That voices us very satisfied.

We will follow that regulation with arguments and see if it satisfies in our own Belgian legislation. If this is not the case, we are still able to move forward and we now have the possibility to move forward in our own Belgian legislation. That is also a good thing for us.

Mr. Speaker, Mr. Minister, Ladies and Gentlemen, I will decide. Some in the committee have said that patents and patents are a neutral data, an objective means of achieving scientific progress, and something objective and neutral, which does not require ethical rearrangement. According to us, this is absolutely not so. We believe that economics cannot be free from morality. For us, this is guaranteed by the design, which absolutely takes into account morality.

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I have submitted many amendments to this draft in the committee but without success. Nevertheless, these amendments pursued ethical objectives and one goal: the non-patentability of the living. Like the directive, this bill allows patenting an element isolated from the human body or otherwise produced by a technical process, including the sequence or partial sequence of a gene, even if the structure of that element is identical to that of a natural element.

This Directive allows to say the opposite of the basic principle of the law, namely that, in application of the principle of non-patrimoniality of the human body, the human body at the different stages of its constitution and development, as well as the mere discovery of one of these elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions. That is why the Greens in the European Parliament voted against this directive. They were among the 20 to 25 percent of parliamentarians who opposed it.

The fact of authorising the patenting of the living has indeed as a result, at the level of the European patent for example, that the European Patent Body does not cease to patent genes. I think we’ve exceeded several hundred patented genes. He is therefore inspired by the same logic by saying that one cannot patent the living, since the human heritage is not patentable. The way things are formulated allows it.

I would like to submit an amendment because I think it is important. It enables research, the development of biotechnologies and also the manipulation of isolated elements of living beings; we actually know that many of them result in remarkable advances in the field of health but also in economic activities. Ecolo is favorable to the development of these technologies, these very advanced methods of research and work but this must be done in respect of the non-patentability of the elements of the human body, animal or plant. This amendment thus incorporates the important nuance that says that living elements can serve as the basis for a patented invention instead of saying that these elements can be patented.

I hear the PS and sp.a-spirit say that Articles 11 and 13 allow to escape the patent for research or, through compulsory licenses, for reasons of public health. I am totally in favour of these provisions and if only that were in the directive, I would sign it with both hands. However, these additions do not prevent the fact that it is allowed to patent the living.

You will tell me that there is an obligation to transpose the European Directive. For example, I find — and I regularly hurry with the Minister in this regard — that in bills transposing directives on the regulation of the gas and electricity markets, there is no hesitation to write articles that are not in line with the expectations of European directives. When one insists and says to the minister that he risks appeals because the transposition is incorrect, he answers that these are risks that one can afford to take.

On this subject that deals with ethical issues, Belgium has not had the courage to modify a paragraph that, in my opinion, meets official intentions, that is, not to patent the living. I do not understand that Belgium has not taken a different position. I consulted the various works, the various discussions. The positioning of Belgium was generally characterized by abstentions. I think this is because, every time, we were influenced by people who defended purely economic interests, considering that associating them with ethical rules was not compatible.

European matters are never just what states make of them. In this regard, along with other countries that delayed or refused to transpose the directive, there was a way, between 1998 and today, to compel the European Commission to clarify the terms better.

I highlighted the inconsistency between the refusal to deviate from the text in this matter and the fact of not hesitating to not follow the word closely the guidelines in other subjects. Where does this inconsistency come from? I think this is part of a clear attitude and line that is followed, aimed at making arrangements to support dominant market players who have monopolistic goals or practices.

In my opinion, it is no coincidence that in recent years there has been so much emphasis on patents and that the notion of patent occupies the entire field of research and economic activity. This is the case for software, it is also the case in the field of medicines, with multinational companies that, despite the content of article 13 of the project, will obtain a new patent for a drug, by simply changing the application, and this in order to prevent the development of generics.

Today we are concerned with the “living”. Actors from innovative small enterprises in these different sectors, which have a good turnover, export, develop subsidiaries, innovate continuously, market new products and create jobs. They say that patent supports and protects powerful companies, except themselves. They add that these large companies have the opportunity to hack them and develop identical products, that it takes them a crazy energy to file a patent, protect it, monitor, attack and defend themselves. A society that spends so much energy on a patent rather than on research and implementation of innovations is a declining society.

In a sector other than the living, than biotechnologies, a company like EVS that works in software where piracy is huge has never filed any patents and has always considered that this would slow its dynamism. However, this company has been one of the best Belgian companies for many years.

I would like to emphasize that I had introduced an amendment aimed at incorporating into the law a provision authorising the Belgian State to permit the export, by means of mandatory licenses, of medicines to developing countries which do not have the means to produce themselves or to purchase at high prices – due to patents – medicines that enable them to fight diseases that decay their population.

Since January 1, 2005, there is no longer any possibility for these countries to fail to comply with the rules on intellectual property within the WTO. An agreement was reached on 30 August 2003 aimed at introducing flexibility mechanisms in the rules on intellectual property in the pharmaceutical sector. Since the European Union has not yet transposed these flexibility mechanisms, I proposed that Belgium take the initiative, as did France, which also prepared a text.

The Minister informed us that the work was intense and that a European regulation could be achieved in very short time. I have therefore withdrawn this amendment. I will transform it into a bill and I will, of course, submit it to the co-signature of my colleagues since they have expressed their agreement, in any case on the objectives pursued, in the event that problems within the European Union would make that regulation is not yet drawn up within a reasonable time.

Mr. Speaker, you will understand that Ecolo cannot vote in favour of this bill. In doing so, we would vote for the patentability of the living, that is, for the living material to become the property of a few, which is completely unacceptable on the ethical level.

For ⁇ twenty years, this directive on the patentability of biotechnological inventions has been the subject of many controversies. After several bills and proposals, fruit of many consultations and negotiations, this bill is finally about to be voted.

The debate that preceded the adoption of this text raised many questions, such as the patentability of the genome or the living, public health, fair trade and the preservation of biological diversity.

This proposal is the result of a compromise. The balances in question were so delicate and sensitive that the delay caused by this transposition is ⁇ understandable.

The issues related to ethics in particular have always been extremely sensitive in our country. Their confrontation with economic interests required a ⁇ difficult balance to ⁇ . The European Commission and the European Parliament had already seen such debates.

However, this project is finalised.

With this text, we will finally allow a growing sector, biotechnology, to develop harmoniously within a clear and current legislative framework.

This new branch of the economy, a major provider of jobs for highly qualified personnel, from our universities and our high schools, will find in this text the way to grow within an extremely active European market.

However, it is of paramount importance to ensure the essential legal certainty in this sector.

Until now, discoveries in this area did not enjoy adequate protection. Many of them, extremely costly in investments, both in personnel and equipment, could not be exploited without being patented. This gap is now filled.

Especially for fundamental research, the universities have not been forgotten. The experimental use exception, as revised here, will allow them to freely use patented objects and processes in scientific experiments. This provision will open the field to research and enable a significant development of knowledge, now hampered by the numerous formalities and costs inherent in the conclusion of licensing contracts necessary for such research.

How many fundamental discoveries have not been the result of chance? How many universities today can afford the luxury of such research for uncertain purposes if it requires negotiating a license to carry it out? They will thus be able to develop a commercial exploitation of their discovery and also offer jobs to their graduates. There could indeed be no question of curbing the current movement of industrial development on the sidelines of academic discoveries.

Public health interests are, in turn, taken into account in the provision that provides for a new mandatory license. If we can understand the concerns of those who have combated this provision, we consider that they are unfounded or that at least they do not justify the abandonment of an essential measure in the event of a health crisis. Furthermore, although some fear abuse, we should point out that the mandatory license is only possible through a strict procedure and it will only be granted after a deliberate decision in the Council of Ministers.

To conclude, we have here a balanced and clear text that will ensure that all actors in the field of biotechnology have the security necessary for the exercise of their scientific activity and for their economic development.

I give the word to the Minister for a response. Then I will go to the article-by-article treatment of this design.

Mr. Speaker, colleagues, I will be relatively short, because the debates today have shown that a majority in the House contributes to a large extent to the goal that we aim with this law, namely the transposition of the European Directive of 6 July 1998 on the protection of biotechnological inventions.

I, of course, heard the reasons for abstinence at the CDH. I have also been able to hear the reasons for the alleged opposition of the Ecolo Group, following the discussion of this bill in the plenary session and in the committee.

In any case, the Directive aims to ⁇ a difficult balance between respecting the desire of our companies to have adequate protection of biotechnological inventions, on the one hand, and the fact that it concerns any living material that forms part of the human patriotism, on the other. Nevertheless, I believe that we have succeeded in achieving the balance that was intended, by enabling innovation and scientific research while respecting fundamentally inviolable ethical rules and principles. The bill itself, Mr. Speaker, is a literal transposition of the Directive of 1998. We have scrupulously followed the opinions of the State Council on this subject. Le projet de loi qui vous est soumis vise également à modifier deux points essentiels de la loi du 28 mars 1984. These amendments are not strictly necessary for transposing the directive but rather to conciliate, in the best way, the different interests and presence. C'est la raison pour laquelle, nous sommes appliqués à trouver une solution pour deux articles, les articles 11 et 13, qui modifient à chaque fois d'autres articles de la loi initiale du 28 mars 1984. As regards Article 11, I can actually be relatively short, because we have tried to remove an existing uncertainty about the correct scope of the article. That was also the reason why I remained quite quiet on the basis of the work. By the way, I also made a statement and submitted a document attached to the report, which was very well represented by the reporter. I have explained the terminology "on" and "with", and also the concept of "scientific purposes" in its broad interpretation and its broad approach. Article 13 of the draft law introduces a system of mandatory licenses in the interest of public health. The scope of application of this mandatory license is the whole of the medical sector, in order to avoid discriminations between the different subsectors.

Here too, I refer to what I stated in my statement before the committee, in which I tried to provide the legal basis, essentially on the ADPIC Treaty (Aspects of Intellectual Property Rights Relating to Trade): the scope, the initiation, the grant procedure, normal and accelerated, the counterfeiting regime and the remuneration regime.

We have also accepted an amendment introduced by the majority. This amendment is a consequence that all the elements will contribute not only to guaranteeing the best balance between the rights of the patent holder and the general interest, but also to avoid all risk of derivation or of discrimination during the implementation and application of this procedure. One last comment, Mr. Speaker. It is essential that this bill is adopted, not only because it is the transposition of a European directive, but also because I believe that, within the framework of the Lisbon strategy, it will undoubtedly contribute to more innovation in a policy area in which Belgium plays a leading role, in particular biotechnology. This provides the necessary legal basis. I ask that the House approve this bill.