Transparency 12: Between the Health Ministry and the Private Industry.
There is a phenomenon in the US called "The revolving door" which consists of the following: Some people, who have been working for the Public Administration, they go to work to private companies which are linked to their prior public activity. Even, sometimes, after a government change, they go back to their positions in the Public Administration. The name of this phenomenon comes from these changes: from the government to the private companies, and from these ones to the government.
Along with this first phenomenon, in some countries we can mention the presence of representatives of the pharmaceutical industry and the offer of services to the officials by members of the administration simultaneously to the practice of their public position, by perpetrating a conflict of interests or Incompatibility.
Apart from the US, this phenomenon worries to all the countries that care about the administrative transparency. For example, we can mention the initiative in Chile presented by the members of the Parliament Jorge Burgos, Patricio Walker, Carlos Montes, Antonio Leal, Eduardo Saffirio, Patricio Hales and Carolina Tohá in 2003. The proposal of legal text was based in the North American compared legislation which typifies the activity since 1946, in the experience which led forward the EU in 1992 and the proceedings of the UK which exists since 1998 for the ministers in their relationships with the lobbies.
Europe was also worried about this phenomenon. Thus, the president of the European Health Council, Dr. Wolfgang Wodarg, accused the lobby of pharmaceutical laboratories as organizers of the psychosis about the Influenza A. In a statement for the French newspaper "L'humanité", he accused the WHO and reported that in this organism, there are personnel linked to the pharmaceutical industry and that the unjustified alarm was not spontaneous but planned.
Recently in France, it has been discussed the action of the French Agency of Health Security of Health Products (AFSSAPS) against the lack of decisions, in relation to the suspicions about the medicines benfluorex (slimming) , buflomedil (vasodilation) and nitrofurantoina (chemotherapy), linked to some favoritisms with certain French laboratories.
Meanwhile in Spain, after a brief review among some important positions in the Health Ministry we can see a worrying scene.
Chronologically we can mention the following cases:
1. One of the CEO of pharmacy and health products in the Ministry of Health and president of the Commission for Evalutaion of medicaments, used to be CEO of the Ministry of Industry and formerly assistant president of the Board of Directors of CDTI, organism which approves the granting of funds to some industries such as the pharmaceutical ones. Named Regina Revilla Pedreira, she is currently director of external relations of Merck Sharp & Dohme in Spain, and the president of the Spanish Association of Bioempresas (ASEBIO), by substituting the minister of Science and Innovation, Cristina Garmendia, who at the same time was founder of the technological company Genetrix in 2000. ASEBIO is composed by over 130 partners, most of them are small companies created from R+D by universities and national research centers.
2. Another director of the Spanish Agency of the Medicament and CEO of Pharmacy, was formerly assistant director of Evaluation of Medicaments, and Director of the Health Research Fund. Named Fernando Garcia Alonso, after his cessation in the Public administration, he has been doing management duties in Market Access by Schering-Plough and Bristol-Myers Squibb and he is currently the scientific director of the Pharmaceutical Group Ferrer.
3. The following director of the Spanish Agency of the Medicament and Health products, former member of the Board of directors of the “Sociedad Estatal de Participación Industrial y Desarrollo Empresarial” and also participated as an expert in facing organisms such as the European Comission or the World Bank. Named María del Val Díez Rodrigálvarez runs Stanpa( National Association of manufacturers of Cosmetic and perfumery products).
4. The last director of the Spanish Agency of the Medicament, recently ceased, who was former member of the committee of scientific assessment of Profarma for the Ministry of Industry, to promote research and technologic development in pharmaceutical industry. Named Cristina Avendaño Sola, during the exercise of her position, she offered assessment services and clinical assays with medicaments through the University of Madrid.
Neither her appointment as assistant director nor her cessation was published in the Official Bulletin of Spain, despite of being mandatory. Due to her recent cessation, we do not know what will be her career.
5. We also must include the current director of the Ministry, who was the assistant director of general medicaments of the Spanish Agency of the Medicament and previously was member of the national commission for evaluation of veterinary medicaments in the Ministry of Health. Named Margarita Arboix Arzo, during her exercise as assistant director, she used to offer advisory services for the necessary studies (wastes, pharmacology, analytics) to obtain the registration of veterinarian specialties through SERAF of the Universidad Autónoma de Barcelona. Neither her appointment as assistant director nor her cessation were published in the Official Bulletin of Spain, despite of being mandatory.
6. Finally, the General Director of Veterindustria, association of the Spanish pharmaceutical industry of veterinary products, is member of the Commission of evaluation of medicaments for veterinary use of the Spanish Agency of the medicament since 1999. Named Santiago de Andres Juarez, is unknown his experience and knowledge in science and techniques related to the medicament of veterinary use as legislation from 1995 requires to be member of the mentioned commission.
Thus, the first regulation about medicaments of veterinary use included in the Law of the Medicament 1990 literally states the following, by discussing about the authorization of trading veterinary products:
“Law 25/1990, on December 20th, of the Medicament (BOE nº 306 on December 22nd [RCL 1990, 2643])
3. The authorization will be granted by the Administration of the Estate prior compulsory report of the National Commission of Evaluation of Veterinary use which will be binding if public health causes are negative”
This law was reformed in 1995 where defines the incompatibilities to belong to the national commission for evaluation of medicaments of veterinary use:
“Real Decree 109/1995 on January 27th, about veterinary medicaments. Published in BOE nº 53 on March 3rd 1995, from page 7353 to page 7409 (57 pages).”
Article 10. Composition of the National commission for the evaluation of veterinary medicaments
2. Belonging to the mentioned commission will be incompatible with any kind of interest derived from the manufacturing or trading of veterinary medicaments or similar products.
4. The Commission will be allowed to permit the presence of a representative from private organizations related to the trading and production of veterinary medicaments”.
The following reform already mentions the incorporation of a member proposed by the Veterindustria management which does not represent the totality of the sector.
In the Official Bulletin of the Estate on October 19th 1999, nº 250 can be read the following:
The Real Decree 520/1999 on March 26th, which approves the statute of the Spanish Agency of the Medicament, establishes in the additional regulation nº 4 that the appointment of the members of the collegial organ of the Agency will be designated by the Ministry of Health and Consume.
We are wondering if Santiago de Andrés accomplishes with the art. 10.2 of the Law 1995: “Belonging to the National Commission of Evaluation for Veterinary Medicaments will be incompatible with any kind of interest derived from the manufacturing or trading of veterinary medicaments or similar products.” As well as the art 23.1 of the Law 1999: “The Committee of evaluation of Medicaments for veterinary use will be composed by 5 members designated because of their workplaces and 12 members designated by the Ministry of Health and Consume during 4 years, among very well-known experts in sciences and techniques related to the medicament for veterinarian use.”.
Due to these facts, we can wonder the following
a) Is there any relation between the exercise of a role in an official organism which grants funds to pharmaceutical companies and the subsequent hiring of the same person in these industries?
b) Is there any relation between the exercise of a role in an official regulatory organism of the pharmaceutical industry and the subsequent hiring of the same person in these industries?
c) Is it possible to exercise influence from the direction from an association of pharmaceutical, cosmetic or veterinary company to the regulatory organisms, when they have been or are being simultaneously as member of the committee for evaluation of the products which want to be traded to the companies of the same association?
d) What happens when considering granting funds to companies that, for own reasons, they do not have wanted to participate in these associations or not have wanted to hire the assessing services in any of the universities linked to the director or assistant director mentioned above?
e) Is it possible that these facts constitute evidence of a plot organized?
f) It is possible that these facts constitute evidence of illegal funding by any group?
g) Are these facts linked to the rejection of the Spanish candidatura for being the venue of the European Agency of the Medicine?
h) Has it been endangered the animal or human health in Spain with these attitudes?