Transparency 30: Spanish Agency of Medicines: Reform or deletion.
In numerous Transparency blogs from Veterinaria Digital, we have provided information about the Spanish Agency of Medicines especially as relates to the field of animal health products. As the economic and institutional crisis are present in Spanish life becomes ever more necessary reform, to be equivalent to their European counterparts, or removal of some structures. We believe that it is time to propose the conditions for reform of this agency described as autonomous and since 2000 has a balance of doubtful efficacy.
Understanding that public health and animal health are closely related we think the role of the Agency is of strategic interest and therefore the first question we ask is whether it should continue as an autonomous entity, given the information currently in its committees includes people related to industrial activity in the sector, or if given the strategic importance should be annulled the autonomous character and become an organ of a ministry. The second question is whether it should continue in the Ministry of Health or should be returned to two sub-directorates general (one in Ministry of Agriculture and one in Ministry of Health) following a previous model known to be effective.
Established institutional location (in Veterinaria Digital we prefer, for the field of animal health products, for a sub in the Agriculture Ministry without involvement of people associated with private companies) consider important proposing some parameters, divided into parameters for members, for the body and for the industry, issues related to running:
Regarding the members
1) The appointments between career officials aspiring to lead and work in the Spanish Drug Agency or alternative organism should go through prior approval of the Parliament, Royal Academy of Veterinary Sciences and Veterinary College Councils and Autonomous Spain.
2) Members of the organism should submit a transparent statement of goods and accept a ban on working in the industry in any sector or employer, within or outside Spain, linked for 10 years after its removal from the body.
3) Members of the organism should undergo an entrance examination and other periodically on their knowledge (eg biannual)
4) Members of the organism should submit an annual individually report of its activities, prioritizing the work resolution on the creation of impediments to industry development.
REGARDING THE ORGANISM
1) The administrative operations of the agency should comply with the requirements of a standard ISO type homologous or similar.
2) The agency shall be audited annually by two independent auditors, one Spanish and other European, and audit reports should be made public. Auditors should change each year.
3) The body shall promote the application of the penal code to irregular activities by staff ascribed to it
REGARDING THE INDUSTRY
1) We propose the removal of subsidies especially those related to research centers related to Agency officials.
2) We propose the possibility of integrating, without tax burden, the value of patents in their balance
These are just some of the proposals to reform the current Spanish Medicines Agency or delete it in favor of other administrative agencies attached to ministries. The matter is urgent because the European Parliament and Council are moving in this direction reformer starting with pharmacovigilance legislation despite having been updated in 2010 has shown serious deficiencies. This new legislation consists of a regulation and a directive. The regulation was adopted by 665 votes in favor, 9 against and 10 abstentions, while the board has received 659 votes in favor to 9 against, with 9 abstentions. The new rules, which will apply from 2013, requires that the emergency procedure to remove the European market any drug banned in one Member State is “automatic” and binding on all states, whereas until now depended on the will of each country. This automation is necessary that the Spanish Agency of Medicines is renovated as soon as possible and to avoid situations, extensible to other countries, as reported in this blog on Transparency.
This reform, as we have indicated in the past, should be accompanied by an external audit and an internal investigation of the activities of the Spanish Medicines Agency from its inception until the date of its reform.