Transparency 24: Some collaborations are transparent?
On April 3 arrived in Spanish veterinarians emails the following information from the College of Veterinarians of each province:
“We enclose, for your knowledge, information conveyed to us the General Council of Colleges Veterinary Spain in reference to a statement from the” Spanish Agency for Medicines and Health Products “: ISSUING: Spanish Agency for Medicines and Health Products Medicines Department. veterinary ADDRESSEE. XXXXXXX Laboratories, SA REGISTERED VETERINARY DRUGS IN SPAIN AND VETERINARY DRUGS NOT REGISTERED IN SPAIN INTERESTED COMMUNICATION:
On March 12, 2012 the Director of the Competent Authority decided to order labs XXXXXXX, SA the recall of sterile aseptic preparation pharmacological drugs manufactured in facilities XXXXXXX Laboratories, SA and distributed to date of the resolution (March 12), the following Defect Quality “deviations found in the manufacturing process of drugs” have been detected. The products subject to recall were shown in Tables 1, 2 and 3, Keep a list over 100 products that affect Spain, Uruguay, Peru, Thailand, Albania, Mexico, Argentina, Egypt, Korea, Ukraine, Pakistan, Bangladesh, Syria, Costa Rica, Ecuador, Guatemala, Morocco and Turkey.
It is also reported that the laboratory has been referred to the Agency a schedule of actions to be carried out, and actually having begun the withdrawal of veterinary medicinal products affected by this alert. “
In Digital Veterinary we get three questions:
1. Is the function of Veterinary Colleges in Spain and the General Council of Veterinary Colleges of Spain the transmission and dissemination of communications command of the Spanish Agency of Medicines?
2. Is it right to transmit a communication of this type to the collegiate without adding a note of the relevant laboratory or your veterinarian technical director?
3. Is it right to transmit information that affects areas or countries outside the geographical scope of Veterinary Colleges of Spain and of the General Council of Veterinarians of Spain?
Consider some information to help us answer both questions.
Regarding the first:
1. Is the function of the Veterinary Colleges in Spain and the General Council of Colleges of Spain Veterinary the transmission and dissemination of communications command of the Spanish Agency of Medicines?
The first relevant information constitute the General Statutes of the Veterinary College Organization Spanish contained in Royal Decree 1840/2000, of November 10, reproduced at the end of the web blog. On them can read that the organization is representative and is independent of the central government, which necessarily groups together all Spanish veterinarians, which relates to the Spanish General State Administration through the Ministry of Agriculture, Fisheries and Food, which has the exclusive representation of the veterinary profession and acting in defense of the professional interests of veterinary colleges and has collaboration with government in achieving the health of people and animals, improving the Spanish livestock and more efficient, fair and equitable regulation and management of the livestock and food sector from the stage of production to consumption, as well as care for the environment and consumer protection.
This information suggests that there is no relationship with the Ministry of Health (where the Spanish Medicines Agency belongs). Perhaps the representatives of MAPA in the Agency has requested the Council diffusion but this should be reflected in any case the statement of the Council. Moreover collaboration with government is based on the health of people, animals affected, the environment or the interests of consumers. Again greater provision of information would be needed because the term quality defect is unspecific.
Regarding the second:
2. Is it right to transmit a communication of this type to the collegiate without adding a note of the relevant laboratory or your veterinarian technical director?
As indicated by the General Statutes, cited above and reproduced in the end,Veterinary Colleges and Veterinary Colleges General Council of Spain whose function is to defend the professional interests of veterinary colleges. It therefore seems appropriate that at least the statement should include a note from the manager of a veterinary technician laboratory and perhaps in defense of their professional interests can provide contradictory information statement from the Spanish Medicines Agency.
The comment regarding the company has submitted a schedule of proceedings does not necessarily mean that the company and its veterinarian technical director are in accordance with the order of recall. Therefore considering it is an organism that brings together the various colleges of the country, through their respective colleges, and since paternity or technical responsibility for the products concerned be attributed to one of their members, should also know the collegiate procedure followed the steps taken-including, of course, that of audience-as well as test systems or methods used to verify the information.
On the third:
3. Is it right to transmit information that affects areas or countries outside the geographical scope of Veterinary Colleges of Spain and of the General Council of Veterinarians of Spain?
The information disseminated affects, besides Spain to 17 countries (Uruguay, Peru, Thailand, Albania, Mexico, Argentina, Egypt, Korea, Ukraine, Pakistan, Bangladesh, Syria, Costa Rica, Ecuador, Guatemala, Morocco and Turkey), so we understand that clearly is exceeded the geographical limit of action of the College and of the General Council of Veterinary Colleges of Spain.
Given the reasonable doubts about the cause of the intervention which involves a public statement from the Spanish Medicines Agency and its transmission through the general counsel and veterinary colleges of Spain (outside its territory, without an appendix statement of the director veterinary technician, without clarification on the impact on health of people, animals, the environment or the interests of consumers) we asked if there is any relationship between this intervention with the presence of the affected laboratory at ADIPREM association, or some business related with the processing of marketing authorizations or other causes as yet unknown.
Also we clarify that the name of the laboratory has been replaced by the symbol XXXXXXX since our objective is to point out some facts that, in our opinion, need clarification. And in any case disseminate any statement Spanish medicines agency over which we have published many transparency blogs analyzing their situation.
Finally in Transparency blog of Veterinaria Digital, we’re serving professionals and the company concerned so that they can report to veterinary sector, what they consider of interest for general knowledge and advocacy for transparency in public administration. We also make available to the Spanish Medicines Agency so you can argue those points that can prove, in a clear demonstration of performance.
