by Janic » 19/08/23, 14:29
any imbecile, therefore within the reach of funny people, will realize that it is not a question of the effectiveness of vaccines but of the industrial and financial efficiency of this business just by reading the participants.
REPORTS OF THE PARLIAMENTARY HEALTH POLICY EVALUATION OFFICE
Wednesday 6th June 2007
- Chaired by Mr. Jean-Michel Dubernard, Chairman -
Round table - "Vaccines in France: what are the challenges for industry pharmaceutical and research?
The Parliamentary Office for the Evaluation of Health Policies held a round table on the theme "Vaccines in France: what challenges for the pharmaceutical industry and research?" », which was attended by Doctor Fabian Wild, National Institute for Health and Medical Research (Inserm) Unit 404 Immunity and Vaccination, Mr. Fabrice Meillier, Regulatory Affairs Officer for Leem (Medicine companies), MM. Hervé Raoul, director, François-Loïc Cosser, unit director, and Vincent Lotteau, in charge of immune and vaccine aspects, at Inserm Laboratoire P4 Jean Mérieux, Mr. François Guillemin, general manager of Lyonbiopôle, Mr. Bertrand Alexandre, Director of the Vaccines BU of Glaxo Smith Kline (GSK) France, Chairman of the Leem Vaccines Committee, Mr. Alain Sabouraud, Head Pharmacist of Sanofi Pasteur and Mr. Eric Lecocq, General Manager France of Sanofi Pasteur MSD, and Mr. Vianney Moreau , Chief Operating Officer Novartis Vaccines.
President Jean-Michel Dubernard, deputy, indicated that this first round table organized by OPEC is being held within the framework of the study in progress on the policy of vaccination in France, the conclusions of which will soon be presented by its rapporteur, the Senator Paul Blanc.
According to an estimate of the World Health Organization (WHO), three million lives are saved each year in the world thanks to vaccination, able today to prevent twenty-six infectious diseases and fight diseases that remain endemic in some developing countries (measles, polio, tetanus or whooping cough).
Le global market of vaccines is expanding: its turnover should amount to 20 billion dollars in 2012, against 8,2 billion in 2005 (including 350 million euros for the French market), i.e. a foreseeable annual growth of 13 % to 14% due to the appropriate responses to the emergence of new viruses (AIDS, severe acute respiratory syndrome [Sras], avian flu, etc.). European laboratories play an essential role in research and development and produce 90% of the vaccines used in the world, even if vaccines still represent only 1,5% of the turnover of the pharmaceutical industry.
For these reasons, OPEC has chosen to study the future of this sector in France, in a context where “anti-vaccination” lobbies are becoming more and more virulent.
Mr. Bertrand Alexandre, director of the BU of GSK France, pointed out that the manufacturers grouped together within Leem strive to offer solutions, to develop new vaccines and tools to evaluate them, but also to help the authorities to define the recommendations and establish financing mechanisms.
Access to the French market is particularly complicated due to a cumbersome and opaque procedure and longer delays than for other health products. A more constructive dialogue would therefore be desirable between the health authorities and the manufacturers, allowing the latter to communicate additional information during the investigation, to comment on the opinion before its publication and possibly to appeal the decision. The objective is to allow recommendations to be issued within a maximum period of one month after marketing authorization (MA). It is also necessary to improve coordination between the various authorities, in particular with the Transparency Commission and the Economic Committee for Health Products, on the issue of the price of vaccines.
The aim of these measures is to improve the value of the vaccine. Currently, this valuation is based on the actual benefit (SMR), based essentially on clinical criteria, while the vaccine also has a significant impact on the general health level of the population. The arrival of a second supplier, offering an alternative to supply, is also a factor that must be taken into account. The benefits are therefore not always immediate, especially since the vaccine has a significant cost for the industry.
If France wishes to maintain a leading position in the vaccine sector, it is necessary to strengthen efforts in the field of research, including through public-private collaborations, and to facilitate the creation of industrial jobs.
The pharmaceutical industry needs the support of the authorities to improve vaccination coverage. Indeed, if 80% of French people and 98% of health professionals say they have a very positive opinion of vaccination, this does not mean that they themselves are vaccinated... In particular, doctors expect a lot from the public authorities to get the message across to the population, who have become cautious about vaccines since the protests against the hepatitis B vaccine. In fact, today it is the laboratories that provide communication on the vaccine [size=150] schedules, without any real help from the Ministry of Health, which is content to publish information on its website. [/ size]
President Jean-Michel Dubernard, MP, wanted to know whether there is a database of complications observed following vaccination.
Mr. Bertrand Alexandre acknowledged that it is certainly appropriate to question the results produced by a vaccine, but also to know the coverage rate of the population and to reflect on desirable changes in the vaccination schedule. You should know that France has a vaccination coverage of only 30% of infants against hepatitis B, against 90% in Germany and Italy, given the reluctance of many patients. Coverage is not optimal either for measles, the virus of which nevertheless continues to rage.
Mr. Fabian Wild, director of Inserm's Immunity and Vaccination Unit 404, pointed out that 90% of children are vaccinated against measles and that the lack of vaccination coverage is rather due to young adults, who were born at a time when vaccination was not as widespread. The virus is not endemic, but imported, and we see with each epidemic, such is the case in Marseille in particular, that young adults are practically the only ones to be infected. In addition, preparatory work for a recommendation for the eradication of measles has shown that people working in the hospital are not sufficiently vaccinated. More generally, it seems that health professionals are not convinced of the need for the vaccine.
Mr. Nicolas About, senator, vice-president, denounced the inaction of the Government in this field. He recalled that he had taken the initiative of an amendment requiring health personnel to be vaccinated against influenza, duly voted by Parliament, but that the Government, anxious not to get angry with health professionals , then issued a decree suspending the application of this obligation.
Mr. Fabian Wild considered that the reluctance of health professionals can be explained by the fact that no courses relating to vaccination are given in French medical faculties.
Mr. Nicolas About, senator, vice-president, agreed, adding that doctors are also destabilized by increasingly complex vaccination methods.
Mr. Fabian Wild pointed out the problem of competition between industry and the Ministry of Health to determine the interest of a vaccine and decide on the avenues of research, according to criteria which may be economic or health.
Mr. Hervé Raoul, director of the P4 Jean Mérieux laboratory at Inserm, indicated that the P4 Jean Mérieux laboratory works on viruses that affect Western countries little, such as SARS or avian flu, even if research tends to be focus on vaccines directly useful to France. The economic criterion is indeed becoming an essential element: the scientific council of the P4 laboratory in Lyon is thus questioning the relevance of research on viruses such as Ebola or Marburg, which affect a few hundred people on the African continent.
Mr. François Guillemin, Managing Director of Lyonbiopôle, recalled that a vaccine intended for humans costs several hundred million euros, which forces companies to make strategic choices.
Mr Bertrand Alexandre pointed out that the pharmaceutical industry develops both vaccines to protect the population of developing countries, for example against malaria or rotavirus, and products with high economic potential which concern more developed countries.
President Jean-Michel Dubernard, deputy, considered this differentiation irrelevant, recalling that deaths linked to diseases in developing countries have occurred in Western countries.
Mr. Hervé Raoul pointed out that the deaths suffered by health professionals in these circumstances were qualified as “work accidents”, which explains why these cases were not followed by prophylactic developments. On the other hand, France will need, in the years to come, high security infrastructures in order to develop vaccines against a certain number of pathogens, which requires maintaining basic research and research and development capacities. The example of avian flu, which can today be controlled by measures in the agricultural field, shows that the appearance of cases of human-to-human transmission will oblige the authorities to develop research programs.
Mr. Alain Sabouraud, Chief Pharmacist of Sanofi Pasteur, argued that, to be effective, a company must focus on a certain number of projects which produce both a benefit in terms of public health and a return on investment, even whether research into more hypothetical vaccines should not be neglected. Thus, the Sanofi Pasteur laboratory resulted, at the time of the SARS crisis, in phase 1 products, but it was the United States that ultimately financed the development of the vaccine, no European partnership having been proposed. The development of vaccines that are a priori less profitable therefore requires assistance from the public authorities.
President Jean-Michel Dubernard, MP, recalled that the round table focuses on three themes: research, whether industrial or within research institutions, innovation and the impact of vaccines and, finally, relations with public authorities in France, but also in Europe and around the world.
Mr. Nicolas About, senator, vice-president, wanted these questions to be dealt with taking into account the strengths and shortcomings of France in this area.
Mr. François Guillemin regretted that the debate concerns only prophylactic vaccines, which are administered before an illness to prevent it, and that issues relating to biopharmaceutical products such as monoclonal antibodies, a sector of activity which is developing at least as quickly and whose regulatory and industrial constraints are nevertheless largely similar.
Mr. Eric Lecocq, General Manager France of Sanofi Pasteur MSD, indicated that Sanofi Pasteur MSD focuses its research on the prevention of new diseases (dengue fever, malaria, AIDS), for which vaccines will be developed in the next ten years. It is also a question of improving the existing programs, in particular by manufacturing quadrivalents and hexavalents, to improve the acceptance rate of parents for the vaccination of their children. However, this is an area where the efforts of manufacturers are not sufficiently recognized. Finally, research relates to new areas, such as the risk of avian flu or chikungunya, which require specific partnerships at national, European or global level.
President Jean-Michel Dubernard, deputy, wanted to know if the relations between industrialists and French or international institutional research are satisfactory.
Mr. Hervé Raoul recalled that Inserm is a public institute which is not only available for academic research. Thus, industrialists who so wish can use its skills.
Mr. François-Loïc Cosser, unit director at Inserm laboratory P4 Jean Mérieux, specified that several Inserm laboratories carry out pre-fundamental research and study viruses at the molecular, cellular and physiopathological level in order to define therapeutic strategies. Thus, the P4 laboratory works on Ebola, Lhasa, avian flu or on chronic viruses such as HIV and the hepatitis C virus, for which there are no vaccines yet and which affect several hundred million patients worldwide, or even on latent viruses or viruses linked to cancers.
Public research focuses on work that industry cannot support for economic reasons and which allows better analysis of the immunological mechanisms involved in order to develop new immunogens which could then have an impact on development. of vaccines. It is then necessary to test these new immunogens. This second stage is located at the interface between public basic research and private applied research, an interface that should be strengthened. In Lyon, the Biopôle has thus promoted major projects that the financial structures of the basic research units alone were unable to support.
Mr. Vincent Lotteau, in charge of immune and vaccine aspects at Inserm laboratory P4 Jean Mérieux, considered that between industrialists and academic laboratories, some links are easy to establish but that others are more delicate because of the reluctance of stakeholders, despite the creation of a dedicated competitiveness cluster in Lyon and the partnership between the P4 laboratory and Sanofi to launch a vaccine trial on chikungunya. The generalization of this type of rapprochement between the public and the private sector would make it possible to accelerate discoveries and produce new vaccines. The example of chikungunya is, in this respect, quite telling, since it is a vaccine prepared by the American army with an attenuated virus which was used in emergency, because the production of such a vaccine by the industry would have taken between five and ten years. It is therefore necessary to develop research programs intended to provoke, measure and control the attenuation of a virus, in order to accelerate the production of vaccines downstream.
Other evolutions must also be considered to predict the appearance of an epidemic. In fact, manufacturers are offering vaccination trials against the bird flu virus, although it is not certain that it is the same virus as that which could affect humans. Research can provide laboratories with measurement elements on the virulence and mutation capacities of the virus.
Mr. Fabian Wild argued that the partnership between research and industry is only viable for the latter if the vaccine produced is profitable. He cited, to illustrate his point, the example of the disease resulting from the Nipah virus, present in herbivorous bats, then in pigs before being identified in humans. One million pigs were slaughtered and 250 people died. It was then considered that even if we were able to produce a vaccine very quickly with an attenuated virus, it was not a priority, since the epidemic only affected poor countries.
Mr. Nicolas About, senator, vice-president, wondered about the means allocated by the public authorities to support research in favor of vaccines deemed unprofitable.
Mr. François-Loïc Cosser considered that public aid is very insufficient in this area. Public research is therefore ill-equipped to conduct projects that fall under basic research, while being quickly transferable to medical applications. In addition to the fact that projects relating to vaccination are relatively expensive, they are not necessarily well rated by the scientific committees of research institutes or the National Research Agency (ANR), unless they are backed by a start-up. up or to a lab.
President Jean-Michel Dubernard, deputy, asked for the opinion of industrialists on the level of development of basic research in French laboratories. He wanted to know if they would prefer to rely on their own structure.
Mr. Vianney Moreau, Director of Operations of Novartis Vaccines, indicated that, as far as Novartis is concerned, research is essentially internal. In Germany, England and India, however, the laboratory maintains cross-functional collaborations with Inserm.
Mr. Alain Sabouraud considered that, for major vaccine laboratories, partnership with public research is inevitable. Today, Sanofi Pasteur has monitoring structures to spot the innovations of research teams, whereas before it was more focused on its own structures. Structures such as Lyonbiopôle have also favored regional partnerships.
Mr. Bertrand Alexandre indicated that Glaxo Smith Kline (GSK) is working a lot in partnership with academic laboratories at a stage when the vaccine is already well developed. He wanted the public authorities to help public research to advance their work until a collaboration is likely to interest the laboratories.
Mr. Alain Sabouraud recalled that the rules applicable to industrial property still played a very limited role a few years ago, whereas today they have a central place. In this respect, French laboratories have long shown greater reluctance in partnerships than American laboratories.
Mr. François-Loïc Cosser pointed out that mentalities have changed a lot in basic research units, where the notion of intellectual property is now well integrated, at least by young researchers.
Mr François Guillemin considered that French public research is generally of high quality, whether it be Inserm, university teams or the Institut Pasteur, but that the transition from research to application is sometimes difficult. Researchers are indeed evaluated on the number of publications, possibly on patents, but not on applications, with the exception of the creation of start-ups. He wanted researchers, who are more developers than fundamental researchers, to also see their work rewarded. With regard to intellectual property, the presence of multiple partners at the origin of the vaccine complicates, in his opinion, things a lot for the industrialist.
President Jean-Michel Dubernard, deputy, recalled that there is currently a movement in research circles which rejects any notion of industrial property and which goes against the principle of patentability.
Mr. Alain Vasselle, senator, wished to know what are the sources of funding for research for industrialists and asked whether the protection of intellectual property is necessary to ensure the self-financing of research.
Mr. Vincent Lotteau indicated that the sources of funding for academic programs consist of ANR funds and European contracts. The institutions, for their part, finance the infrastructures and pay the salaries.
Mr. François-Loïc Cosser deplored the low level of investment by private pharmaceutical research in fundamental programs. Taking the example of AIDS, he indicated that the ANR has an annual budget of 45 million euros, of which a good half finances clinical trials, which does not ensure the financing of research in upstream. The same is true for avian flu, since it was not until 2007 that an agency capable of financing programs was set up.
Mr. Bertrand Alexandre acknowledged that the industry first invests in projects that are already advanced. Complementarity between public and private funding is indeed possible from a certain stage of project development.
Mr. Eric Lecocq added that the financing of private research is essentially based on turnover. The public authorities must therefore finance fundamental research more widely, as the American State has done on avian flu.
Mr. Alain Sabouraud specified that the European research programs only represent a few million euros, while the American programs are of the order of one hundred million euros.
Mr. Alain Vasselle asked whether the level of investment in private research has varied over the past ten years.
Mr. Alain Sabouraud indicated that it increased slightly at Sanofi Pasteur during this period.
Mr. Bertrand Alexandre specified that the budget devoted to research is increasing, which means that, in relation to the turnover which is itself increasing significantly, the research budgets are increasing considerably.
Mr. Fabian Wild estimated that, in the field of vaccination, it is necessary to find funding for risky projects.
President Jean-Michel Dubernard, MP, wanted to know if public research is open to start-ups.
Stating that he himself participated in a start-up, Mr. François-Loïc Cosser considered that the financing of start-ups is relatively satisfactory in France as regards the initiation phase of projects, which amount to hundreds of thousands of euros. On the other hand, the development phase of start-ups, after six to twelve months, is often more difficult to envisage, due to the reluctance of investors and the pharmaceutical industry, which is only ready to commit when the project is already very advanced.
Mr. Bertrand Alexandre recognized that the pharmaceutical industry only participates in projects if they are sufficiently advanced and the risk perceived by the industrialist is low.
Mr. Nicolas About, senator, vice-president, asked why investment funds do not provide the necessary financing for start-ups.
Mr. François-Loïc Cosser deplored the lack of risk-taking in this regard.
Mr. Bertrand Alexandre argued that the French and European pharmaceutical industry does not have the American financial power. It is therefore appropriate to focus on very specific areas, depending on the needs of France and the technologies available to it.
Mr. Eric Lecocq considered that the essential problem comes from the fact that there are no French or European investment funds.
Mr. Claude Le Pen, member of the committee of experts, acknowledged that the weakness of the venture capital market in France poses a problem. American pension funds make it possible to raise colossal sums, part of which is invested in risky companies.
Conversely, President Jean-Michel Dubernard, deputy, has hypothesized that the French market is structurally weak due to its size.
Mr. Claude Le Pen argued that, proportionately, the venture capital market in France is weaker than it should be, including taking into account the size and wealth of the country. In addition, the mechanism of secondary financing does not work satisfactorily, because an investor commits for a limited period and wants to be able to leave the project when he wishes and not have to face the unexpected. However, in France, people are wary of the financial market, which is associated with speculative stock market activity, whereas it plays an important economic role in modern societies, in particular for the financing of innovation.
President Jean-Michel Dubernard, deputy, lamented that, since the report he had submitted in December 1994 to Edouard Balladur, then Prime Minister, on technology transfers in the field of health, little has changed: researchers are often not motivated by start-ups, industrialists, for their part, are only interested when the project is profitable and venture capital does not commit.
Mr. Bertrand Alexandre considered that funds specializing in the field of health do not invest, for lack of evidence from the public authorities of the desire to advance these projects sufficiently to reduce the risk.
Mr. Eric Lecocq added that industrial investments must respond to public health problems according to the criteria of the Economic Committee for Health Products.
Mr. François Guillemin indicated that in the United States, pension funds ensure the secondary financing of projects. However, it is sometimes difficult to find the subtle alchemy between a high-level scientist and a manager to whom he agrees to entrust his project.
President Jean-Michel Dubernard, deputy, considered that the mentalities and the image of industrialists have changed within the scientific community.
Mr. Hervé Raoul recalled that if high-level researchers wish to promote their research, they come up against the evaluation system, which obliges them to return very quickly to basic research work allowing them to be published in journals such as Science or Nature.
Mr. Claude Le Pen considered that the problems of liaison between university research and industry are not specific to the vaccine, but arise in the whole of the biomedical industry, as the diagnosis has already been clearly established in a series of European reports.
Mr. Nicolas About, senator, vice-president, wanted the issue of vaccine production capacity in France to be raised.
Mr. Alain Sabouraud indicated that the export represents more than 80% of the volumes manufactured. The vast majority of vaccines are manufactured in France or in Europe, even if we are now seeing the creation of companies in emerging countries, which no longer want to be satisfied with the local market alone, but also export. This pushes us to think about the location of their production units. In fact, all the major vaccine producers are setting up units in emerging countries where production costs are lower and the local market attractive. However, the laboratories continue to invest in France and in Europe: thus, more than 100 million are invested each year in the production tool and more than two hundred people are employed each year by Sanofi Pasteur in France.
Recalling that the world's leading producer of measles vaccines is Indian, Mr. François Guillemin estimated that, like textiles, the vaccine industry will have to relocate.
Mr. Alain Sabouraud noted that the selling prices of certain measles vaccines are lower than the production costs in France. Costs must therefore be lowered, which will perhaps lead to a change in the panorama of the supply of vaccines.
Mr. Vianney Moreau indicated that Novartis is committed, for its part, to securing the production tool, developing it and improving it, in particular through new technologies, such as cell culture vaccines which make it possible to get rid of egg production completely so as to achieve a much higher reproductive rate. Novartis has factories in India and China, for cost reasons.
Mr. Bertrand Alexandre declared that GSK continues to invest in France, since the laboratory devoted, in 2006, 500 million euros to the establishment of a factory which will contribute to the production of several new vaccines, including a vaccine intended to prevent HPV (Human Papilloma Virus) infections. This site is close to the production units in Belgium. Despite everything, GSK wonders about its next investments: if the question of the cost of production is not essential, the great advantage of investing in India or China remains access to local markets.
Mr. Eric Guez, of Novartis Vaccines, noted that there is an increasingly important competition between the countries for obtaining vaccines, in particular against influenza. The local market price is very important and determines availability choices. In France, prices are so low that manufacturers sometimes choose to serve other countries.
Mr. Nicolas About, senator, vice-president, wanted to know if the fact that social security reimburses a certain number of vaccines makes France a special case.
Mr. Eric Guez refuted this hypothesis by indicating that vaccines are less reimbursed in France than in certain countries. This is the case with flu vaccines, for example: prices are lower there than in Germany, Italy or Belgium.
Mr. Fabian Wild argued that children in France are vaccinated with American vaccines like MMR (measles-mumps-rubella).
President Jean-Michel Dubernard, deputy, questioned Mr. François Guillemin on the activity of Lyonbiopôle in terms of bringing together research and the vaccine industry.
Mr. François Guillemin explained that Lyonbiopôle aims to bring academic research closer to companies by labeling projects to which funding is allocated, some of which comes from the Ministry of Industry. Most of the funding for labeled projects is intended for SMEs or academic research organisations. He cited two examples of projects, the first relating to the flu virus and involving, among others, Merial, Sanofi Pasteur, Inserm teams and university teams in Lyon, the second with Inserm, Becton Dickinson and Sanofi, which deals with a new way of administering the vaccine. The partners receive funds from the Ministry of Industry insofar as these projects must contribute to producing economic development.
President Jean-Michel Dubernard, MP, wanted to know if the Industrial Innovation Agency (AII) is also involved in projects.
Mr. François Guillemin indicated that work is currently funded by the IIA on new diagnostic technologies, but none in the field of vaccines.
President Jean-Michel Dubernard, MP, asked Mr. Claude Le Pen for a summary of the issues discussed.
Mr. Claude Le Pen estimated that three problems specifically affect the vaccine in France: first, the validation system, which is quite cumbersome and not very transparent; then, the economic evaluation of the vaccine, which is modeled on that of the drug and does not necessarily take into account all the dimensions of public health; finally, the fact that there is a more general problem of vaccination coverage.
In addition, the status of vaccines is highly variable. Some are not reimbursed at all, others are on prescription, others are also reimbursed because they have been the subject of recommendations. A part is paid by the risk, another by the national fund for prevention, education and health information. Support is therefore complex, as is the accreditation system.
Regarding vaccination coverage programs compared to other countries, the French are rather less covered, including the health professions.
President Jean-Michel Dubernard, deputy, considered that there is a lack of scientific data allowing the usefulness of vaccines to be assessed. He then wished to know what the relations between research and industry are with public authorities at world, European and national levels.
Mr. Claude Le Pen recalled that vaccination is one of the specific and traditional missions of the WHO.
Mr. Eric Lecocq clarified that the WHO supplies manufacturers with the strain for flu vaccines. Recently, the Indonesians have also threatened not to entrust their strains to the WHO, on the grounds that they do not benefit from a sufficient return in the event of a pandemic.
Mr. Nicolas About, senator, vice-president, pointed out that it is important, within the framework of the social security financing bill, to have a watch covering all the inconveniences resulting from vaccines. He asked if there is a really opposable data bank, which would make it possible to define a more effective vaccination policy. He also wanted to know if there is a policy of vaccination of immigrants.
Mr. Eric Lecocq recalled that the High Council for Public Hygiene recently underlined the need to set up epidemiological tools, the absence of which is particularly harmful in France. He considered that the French association for health safety and health products (Afssaps), the general directorate of health (DGS) and the national health insurance fund (Cnam) should create a common epidemiological tool. He indicated that the psychosis around the hepatitis B vaccine is so powerful that one of the fears raised by the implementation of a vaccine against the papillomavirus is that a vaccinated young girl will then develop a multiple sclerosis. However, the health authorities are not able to say how many multiple sclerosis cases affect the general population, which would nevertheless make it possible to establish a comparison with the number of cases which would occur within a vaccinated population.
President Jean-Michel Dubernard, deputy, argued that the parliamentarians had tried to deal with this problem within the framework of the law relating to public health by giving a public health mission to the school of Rennes.
Mr. Eric Lecocq added that one of the reasons why rotavirus vaccination is not being developed is that the exact number of intussusceptions in the general population is not known.
Mr. Bertrand Alexandre deplored that the invocation of the precautionary principle is not accompanied by tools enabling the impact of such or such vaccination to be measured.
President Jean-Michel Dubernard, deputy, considered that these tools can be implemented in a strictly national framework and that it is up to the WHO to take up the issue.
Mr. Nicolas About, senator, vice-president, asked if the personal medical file could not contribute to a better statistical knowledge in the respect of medical secrecy.
Mr. Claude Le Pen recalled that the personal medical file project is blocked for financial reasons.
Mr. Bertrand Alexandre indicated that all vaccines are subject to the registration of a risk management plan at European level. However, these plans are not necessarily carried out in France, for lack of the necessary epidemiological tools. The Nordic countries, on the other hand, have developed effective surveillance tools. In addition, the Afssaps requires additional data from the laboratories. All in all, the task of manufacturers is considerably complicated by the French procedure.
President Jean-Michel Dubernard, deputy, wanted to know the state of relations between European structures and national structures.
Mr Eric Lecocq recalled the fundamental role of the WHO at the global level; at European level, an organization brings together all of the vaccine manufacturers; in France, finally, there is Leem-Vaccins. Access to the French market is particularly difficult. In fact, compared to the drug, the vaccine is subject to an additional step, that of the recommendation. The opinion of the Technical Committee for Vaccinations is necessary and must be approved by the High Council for Public Health. The absence of visibility is also total in terms of deadlines.
President Jean-Michel Dubernard, deputy, asked whether the quality of the Afssaps experts can be questioned.
Mr. Bertrand Alexandre considered that the difficulty stems solely from the cumbersomeness of the procedure, but that the dialogue between industrialists and experts must also be strengthened.
Mr. Eric Lecocq recalled that the health watch institute (InVS) issued an opinion on a vaccine against rotavirus, considering that its cost was too high, without bringing any confrontation of ideas, nor any proposal from a different price, nor any details on the epidemiological bases that were used to evaluate the vaccine. For example, no account is taken of sick leave, because each paying agency refuses to take into consideration all of the costs covered.
Mr. Bertrand Alexandre added that, moreover, there is no possible recourse for a laboratory.
President Jean-Michel Dubernard, MP, wanted Leem-Vaccins to draw up a summary of all these questions.
Mr. Claude Le Pen argued that governments are very reluctant to the idea of European cooperation on the economics of drugs, even if the regulatory and technical aspects can be integrated. In addition, a 1989 directive specifies that the States have their own pricing and reimbursement criteria.
Mr. Nicolas About, senator, vice-president, was surprised by the average vaccination coverage of France, while it is one of the most restrictive countries in terms of compulsory vaccination.
Mr. Claude Le Pen estimated that this result is rather the fact of a stronger anti-vaccination lobby than in the other countries.
Mr. Alain Sabouraud added that there is no promotion of the vaccination policy in France, unlike that carried out at world level by the WHO or in the United States by the Center for Disease Control. He felt that, faced with the anti-vaccine lobby, the laboratories are in a bad position to promote the vaccine. This role could, however, be entrusted to the Technical Committee for Vaccines (CTV).
Mr. Eric Guez considered that distrust of the vaccine is, in France, a lack of confidence in the results.
President Jean-Michel Dubernard, MP, agreed, recalling that there is no scientific evidence on the usefulness of vaccines.
Mr. Nicolas About, senator, vice-president, noted the better penetration of vaccines in other countries.
Mr. Bertrand Alexandre estimated that the episode of hepatitis B largely explains this particular situation. A communication effort on the part of the public authorities is therefore particularly necessary.
Mr. Claude Le Pen recalled that the vaccine industry has long been on the sidelines of the pharmaceutical industry, marked by a culture of biologists, much more than by a clinical culture. This situation is changing due to the current vaccine revolutions: the industry is restructuring, markets are expanding, new players are appearing.
President Jean-Michel Dubernard, MP, concluded by considering that the public authorities should have a complete vision of the industrial landscape as well as possible links between public research and private research.
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thus JM Dubernard who does not show any antivaxx attitude, underlines that;
President Jean-Michel Dubernard, MP, agreed, recalling that there is no scientific evidence on the usefulness of vaccines. Before him, the president of the Superior Council of Public Hygiene in France had made the same observation
NO PROOF!
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"We make science with facts, like making a house with stones: but an accumulation of facts is no more a science than a pile of stones is a house" Henri Poincaré
and the more he does not even know how to read and analyze the site he indicates /
