Transparency 15: Structural and Operational Deficiencies. Part 1
In Transparency weblogs from number 6 to 14 inclusive, five structural defects of the Spanish Drug Agency, Ministry of Health, have been reported : the absence of the required publication on appointment and dismissal of director and deputy director general (hence her appointment outside on merit and the exercise of a position without publication of mandatory appointment), the presence of private vocal in several official committees (in contradiction with legal incompatibilities identified in the drug law 1990 and 2006), proceedings of committees with expired appointments and not carried over, conflicts of interest and incompatibilities and the provision of services to overcome the regulations by the same officials who must implement these publications regulation. None of these publications in Veterinaria Digital have been denied or disputed by the Spanish Agency of medicine and complaints to the responsible politicians of this institution have had the answer in silence for most of the time or sending the letters to the same responsible for the deficiencies.
From this blog we want to point out deficiencies in internal operating mechanisms, especially in the processing of files. We donât know, for now, if these deficiencies can be crimes in themselves but as the reader will understand, they create reasonable doubts about the objective of these deficiencies, because its repetition makes one suspect that they are not treated as mere mistakes.
We are highlighting 4 performance failures,that can be joined to the 5 structural defects in the Spanish Agency of Medicine:
1. Delays in homologation files.
2. Lack of action according to the procedure laid
3. Formal errors according the legislation
4. Deficiencies or concealment of essential information in the execution of judgments
In the first case, some examples can be shown:
A) Delay of 8 years less three weeks in the processing of the approval of a veterinary product that be processed within 90 days.
B) A second example is the delay of 8 years and 1 month in the processing of approval for another veterinary product.
C) The third example is the delay of 7 years and 9 months in the processing of approval for another veterinary product.
D) The fourth example is the lag of 8 years at least 2 weeks in the processing of approval for another veterinary product.
E) The fifth example is the delay of 6 years and 10 months in processing of approval for another product for veterinary use.
These delays mean that between application filling for approval, made under Law 25/1990 of the drug and Circular 5 / 94 June 1994, until the time of issuing negative reports have come into force new legislation (Royal Decree 109/1995).
The Agency issues a negative report with years of delay and from Veterinaria Digital we wonder:
1. Why didnât the drug agency requested any documents in the passed years
to the view that the legislation has changed during the process?
2. Is it adequate that a state agency delayed for many years the formalities for
certain files and not for others?
3. Does the negative report is really negative in itself or it is trying to hide the delay and that admission of the validity of the request would be admitting a backlog of a proper documentation?
4. Is there any relationship between these delays, and negative reports from 2003 and 2004 with the offer of services in 2001 by Seraf, led by Margarita Arboix in the time she was Deputy Director of Veterinary Medicines? See Transparency 7 and 9.
5. In the case that there is a real relation, are we in front of a charge of 54,000 euros by a delayed file, that is receiving in 2003 a negative report, after non-acceptance of the services provided in 2001?
6. Are we dealing with real or operational deficiencies or are them deficiencies to achieve other objectives?
7. How can an state agency collect many structural and operation deficiencies without any kind of action when complaints or internal research applications received?
The following weblogs will deal with the lack of action according to the prescribed procedure in respect of the formal defects of the legislation and the gaps or concealment of essential information in the execution of judgments.