Transparency 18: How to accelerate the launching in the market or omit the incompatibilities?
The Spanish Technologic Platform of Animal Health (Vet+i), is according to their own presentation, a multidisciplinary forum that integrates to the animal health industry, the competent authority in the field, universities, the veterinary profession, livestock sectors productive, scientific community and other interested experts in animal health.
Vet+i pretends to be, according to their own presentations, a dynamic and efficient tool that enhances the contact and discussion to achieve its primary purpose: that the animal health research carried out in Spain becomes transferable, and to facilitate and accelerate the development and the launching of tools to the market.
From Veterinaria Digital we wonder the following: How come a technological platform can accelerate the development and launch in the market?
Searching for some answers to this question, we found the following text from the own interested parties.
“Presented the Spanish Technological Platform for Animal Health (Vet + i), promoted by employers Veterindustria and James Andrew, CEO of Veterindustria, who has been elected chairman of the Management Council of the Spanish Technological Platform for Animal Health (Vet + i).
The Management Council of the Spanish Technological Platform for Animal Health (Vet + i) has been formed following a meeting at the headquarters of the Spanish Business Association Industry Animal Health and Nutrition (Veterindustria), which performs the functions of the technical Secretary Platform. At the same meeting, held on the ninth day was appointed Santiago de Andres, CEO of Veterindustria, as President of the Management Council. “
On the other hand, in the Official Bulletin of the Spanish State we can find the following:
“No. 95 Tuesday April 20, 2010 Section I. Page. PRE/962/2010 Order 34 669 on April 15th, regulating the Committee of availability of veterinary medicines.
The Royal Decree 1246 of 18 July 2008, which regulates the authorization procedure, registration and pharmacovigilance of veterinary medicinal products industrially manufactured, created in its third additional Committee availability of veterinary medicines, while establishing the need to develop their composition, functions and performance, by ministerial order.
This Committee was created to promote the availability of veterinary medicines for all livestock species for food production, as well as pets, especially through actions to encourage, promote and support research, experimentation, development, registration and marketing of themselves”
“According to a proposal from the Ministers of Health and Social Policy and the Environment and Rural and Marine Affairs, and with prior approval from the Ministry of the Presidency, I propose”
Article 2. Organization dependency.
The Committee of availability of veterinary medicines is attached to the Spanish Agency for Medicines and Health Products, through the Directorate General for Medicinal Products for Veterinary Use.
Article 3. Objectives and functions.
e) In the case of immunological medicinal products, define a list of indications
g) Prepare reports on the need to establish maximum residue limits for certain species in pharmacologically active substances.
Article 4. Composition.
3. º For the industrial sector, two members appointed by the Minister of Health and Social Policy and proposed by the sector of veterinary pharmaceutical industry.
7. ° A representative of the Spanish Technological Platform for Animal Health (Vet + i) appointed by the head of the Ministry of Health and Social Policy, proposed by themselves.
Final Disposal. Entry into force. This order shall come into force the following day of its publication in the “Gazette.” Madrid, April 15th, 2010. – The First Vice President and Minister of the Presidency, Maria Teresa Fernandez de la Vega
It seems that the answer to our question is that Vet + i have a member in this new government commission. As noted in our blog TRANSPARENCY (16): Guarantees of independence?
Article 3.4 of Law 29/2006, of July 26, on guarantees and rational use of medicines and medical devices published in BOE No 178 on July 27th, 2006 pages 28122-28165 which can be read literally:
“Article 3. Guarantees of independence.
4. The Membership to the committees of the Spanish Agency for Medicines and Health Products, the Clinical Research Ethics Committees or committees or advisory or consultative bodies established by the health authorities of the Autonomous Communities is incompatible with any kind of interest in manufacturing and marketing of medicines and medical devices. “
On this basis, who can explain the presence of the member of Vet + i in the Committee on Availability of medicinal products in the Spanish Drug Agency?
Finally, the question is, does anyone think that can accelerate the launching on the market pertaining to the evaluation committees and availability, contrary to Article 3.4 of Law 29/2006, if you must go through the evaluation committee to also member and the deputy director of veterinary drugs involved somehow in the platform Vet + i?