Proposition 53K0648

Proposition de résolution relative à la médecine personnalisée et aux défis pour notre système de soins de santé.

General information ¶

Authors

MR David Clarinval, Damien Thiéry
Open Vld Maggie De Block, Gwendolyn Rutten, Ine Somers, Carina Van Cauter
Vooruit Maya Detiège

Submission date

Nov. 19, 2010

Official page

Visit

Status

Adopted

Requirement

Simple

Subjects

medicine medicinal product genetics health care system resolution of parliament public health

Voting ¶

Voted to adopt

CD&V Vooruit LE PS | SP Open Vld MR VB

Abstained from voting

Groen Ecolo N-VA LDD

Party dissidents ¶

• Peter Luykx (CD&V) abstained from voting.

Contact form ¶

Do you have a question or request regarding this proposition? Select the most appropriate option for your request and I will get back to you shortly.

Discussion ¶

July 13, 2012 | Plenary session (Chamber of representatives)

Full source

Mrs Nathalie Muylle, who is also apologized, refers to her written report.

Mr. Speaker, Mr. Minister, allow me, on behalf of the Reform Movement, to welcome the debate that is on the agenda today in this assembly.

During the previous legislature, the Opinion Committee on Scientific and Technological Issues worked hard on drafting this proposal for a resolution. Numerous hearings were conducted with a panel of experts of very high quality. I would like, first of all, to take advantage of the opportunity offered here to pay tribute to two former colleagues who have been the instigators of this case and who no longer sit among us today. These are Dr Yolande Avontroodt and Prof Christine Van Broeckhoven. With their advanced knowledge in the matter, they have, with pugnacity, conducted the master-hand work leading in the end the opinion committee to produce a text winning a very broad adherence. I would like to thank them especially today.

The debate is about personalized medicine, which is a major challenge for the future of public health. We know that a medication prescribed for a given pathology in a patient does not always cure it or can sometimes cause very significant side effects. In-depth knowledge of pathologies and patients, thanks to increasingly accurate diagnostic tests, allow to direct a patient to a targeted treatment and avoid others despite identical clinical signs. Each patient is unique and should receive the treatment with the best chances of leading him to healing. This is the starting postulate of personalized medicine.

Personalised medicine is characterized by the use of data primarily from genomics to select tailor-made therapies for each patient. It is therefore a matter of better targeting medical interventions and reducing the side effects of drugs.

Personalized medicine therefore has the advantage of increasing patient compliance with their therapy.

Medications should target the specific molecular mechanism that occurs in a specific portion of patients and then be applied to that portion of the population. This is called the stratification of the population. This results in a more effective and more targeted treatment, as well as a reduced risk of side effects.

In order to be able to stratify and personalize medicine, new diagnostic tools must also be available that can select respondents reliably. In this case, the whole challenge is also to find biomarkers that are sufficiently distinctive. The development of more effective and targeted drugs for each pathology cannot be done without the discovery of the biomarkers associated with it.

Of course, the debate does not escape the ethical and social questions. We believe it is important to evaluate ethically and critically this new form of medicine. Many questions arise. As an example, we can cite the right, for a patient, to know or not his medical predispositions. We can also talk about respecting privacy and privacy for patients. So, for example, what would be the use of these genetic data by insurance companies? It is also possible to speak of free and informed consent for the conduct of pharmacogenetic research. Finally, this raises the question of equitable access to this type of medicine. One could imagine that some research would be more pushed for audiences that, genetically, would be richer.

We could conduct research for a public that we know is potentially richer. This can be determined genetically.

They could make groups, groups.

Or, these are ethical questions that arise and that need to be the object of special attention. These aspects are addressed in points 9, 12, 13 and 14.

Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker. He proposes to the government no less than 16 concrete actions to develop in the coming years to frame personalized medicine. Our country is at the forefront in many areas and is, in particular, recognized for its high quality of care. We must remain at the top of the framework of personalized medicine, which is a challenge for the future, a challenge for tomorrow.

Mr. Speaker, I take the floor to show that the Flemish Belang Group is there. After all the bitter pills we had to swallow yesterday, we can still give positive approaches.

The Flemish Belang group supports the majority proposal for a resolution on personalized medicine, with which the federal government at least does not set any barriers to the further development of the Flemish biotechnology companies. I would therefore like to thank the colleagues who, not only in this legislature, but also in the previous legislature, have put their shoulders under the creation of the present draft resolution.

Personalized medicine is not only of great importance for our future healthcare system, but also for the further global profiling of our biotech companies and our universities and scientists.

Of course, we must not forget the ethical aspect associated with this. The draft resolution also pays due attention to this. I am confident that we, together with our colleagues, will be able to bring this to a good end.

We always find it strange that the majority asks questions to the majority, but as far as the question is concerned, we will support the majority question.

In recent decades, important medicines have been developed. This includes medicines for those who suffer from a particular condition.

At the same time, however, doctors have also found that a drug does not necessarily give an identical result in patients with the same diagnosis. For example, I think of drugs to fight cancer. What appears to be effective for one patient, does not provide sunshine for another.

The discovery and progressive understanding of the mechanisms of action of various diseases, led to new possibilities in which drugs were developed for a particular type of patients with a condition. A new era in the medical treatment of patients was also initiated immediately. It focuses on patient characteristics, both in the research of new medicines, in the administration and in the preventive medical intervention. This also puts us, policy makers, before major challenges.

We must today adjust our policies in terms of substance, financial and ethical to make medicine of tomorrow possible. That is why the present draft resolution was written and adopted.

A personalized medicine has implications both in the field of curative medicine and in the field of preventive medicine. If we know that certain personalized medicines only affect a limited group of patients, then we need to be able to map that group of patients. In this way, we do not have to deliver expensive medicines to patients who do not benefit from them, who experience a lot of side effects and, meanwhile, see their illness continue to worsen.

The identification of patients requires the development of biomarkers that allow to determine whether the patient is susceptible to a particular treatment. Describing the genome, of course, also allows for predictions regarding the hereditary load and the development of certain conditions. This allows a limited number of conditions to prevent the development of the disease. Here too, we will again have to look for methodologies to detect those groups of patients.

The possibilities are huge and that all has a cost, which may be higher than the cost of current medicines. On the contrary, we should not carry out useless, expensive treatments, because we can better define the target group, which allows us to better estimate the success rate of medicines. Therefore, we will have to determine which individuals we will map the genome. Since the cost cost is also not insignificant, we as policymakers will have to determine which risk groups we want to detect and with what finality.

Not to be underestimated are the ethical aspects of the new knowledge and capabilities. What do we do with the findings made by doctors that we were not looking for at first, especially if there is no treatment for them? Should this conclusion be communicated to the patient and his family? We must be aware that such a diagnosis can seriously mortgage the lives of patients and their families. What about the responsibility of persons in which a condition is established that is hereditary? What about granting the refund for an individualized medicinal product if the biomarker does not indistinguishably indicate that the patient belongs to the target group for which the individualized medicinal products are effective?

The moral burden on the doctor, the patient and society that results from it can hardly be overestimated. Therefore, we need a deep reflection on this, a social debate. In this sense, a new debate on this subject is being held in the Bioethics Advisory Committee.

The collection of patient data in the framework of the research, of course, also requires measures to protect the privacy. There may be some ground breaches for the privacy commission on this subject. However, international exchange of data is essential for scientific research. No one is allowed to stay on their data, for this there is too much at stake.

I do not want to finish my speech without expressing my thanks to the initial authors of this draft resolution in the previous legislature, and in particular to my colleague and party colleague Yolande Avontroodt, who took the lead at that time. Their merits in the file should not be underestimated.

Mr. Speaker, I hear from everyone here that this resolution is very important, but when the discussion begins, almost no one is present, including the applicants.

This branch of medicine is in full blossom but is still in the children’s shoes, with very many unknown factors. Also here it is so that the more one knows about the subject, the more one realizes that one actually does not know very much and the more questions arise. I therefore feel quite a bit of scorn to extend myself here, despite being scientifically educated, as a non-specialist on this subject. I will ⁇ not do that.

The possibilities of personalized medicine are virtually unlimited. So there is a huge potential, but this also represents a huge challenge for very many aspects of our health care. This goes from the purely personal through the patient-focused and medical to the ethical aspect. I heard colleague Somers advocate for the ethical aspect, but in the committee there is ⁇ little said about it, which I actually regret. Furthermore, there is the financial picture of this personalized care. So we will have to make sure that all this remains affordable.

We fully support the development of this branch of medicine. We have therefore convincedly supported the vast majority of this resolution. On the available part, however, we have three comments.

The first point concerns the regulation and the drafting of guidelines on safety, quality and clinical usability. Regarding the continuous monitoring of the impact of the development of this science, we believe that we can better focus on the European level. We must not all do that here in Belgium on our own, we can better leave it to Europe and fully cooperate with Europe to get there for guidelines and monitoring. We should not invent all sorts of rules on our little island that may later have to be changed by Europe.

We are also surprised that this resolution dictates in which the industry should invest. Science is still in its infancy and then it is very dangerous if a parliament gets to work hard and orders the industry to invest in it. Investments should be made in biomarkers for prognosis, biomarkers for early diagnosis, toxicity markers, markers and technologies that allow the patient to be identified and selected, and so on.

We have agreed that, ⁇ in such a technical and specialized subject, the government is there to ensure that science can be done, that scientific research is framed and supported, not to impose the industry into which to invest. This is not the task of Parliament.

Paragraph 10 of this resolution provides a dangerous precedent. We will therefore submit an amendment. With regard to the preliminary testing of pharmacogenetic parameters, the same rules should apply to generic and patented medicinal products. The whole philosophy of the generic industry, the whole business model, starts from bio-equivalence: one must demonstrate that it is equal to the original. A registration procedure for a generic medicinal product ensures that the quality, safety and durability of the medicinal product are identical to the original. It is important for us that it remains.

This resolution now suddenly states that the generic industry will also have to conduct large-scale clinical trials. I think this is a very dangerous precedent because it shakes the economic story of the generic industry. We have concerns about this. We are fully in favor of a very strict control of bioequivalence, which may not always happen now. Once bioequivalence has been proven, the generic product should be able to come on the market for us. When, on the contrary, we compel generics to undergo large-scale clinical trials, they either become much more expensive, or they are no longer on the market. In both cases, this is a bad thing for health care.

On its own, we find this resolution good, but for the reasons I have cited, we will not adopt it. We will therefore abstain from voting unless, of course, our amendment is approved.