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18.05.2006 General News

Two In Power Struggle Over Drug Control

By Graphic
Two In Power Struggle Over Drug Control

A power struggle is raging between the Food and Drugs Board (FDB) and the Centre for Tropical Clinical Pharmacology and Therapeutics (CTCPT) over who should take charge of pharmacovigilance in the country.

For the past five years, the CTCPT of the University of Ghana Medical School (UGMS) has been designated by the Health Ministry as the National Centre for Pharmacovigilance (NCP) and tasked with the responsibility of monitoring adverse drug reactions.

But the FDB has taken issue with that and declared its intention, with authorisation from the Minister of Health, to take over that responsibility, despite strong resistance from the CTCPT, which insists that it is still the recognised NCP.

The Chief Executive of the FDB, Mr E. K. Agyarko, told the Daily Graphic that with the directive from the Health Ministry, no institution had the right to hold itself as the NCP.

In a rebuttal, the acting Director of the CTCPT, Dr Alex Dodoo, said his outfit had not been informed about the re-designation of the centre and that until the ministry did so, it would continue to discharge its function as the recognised national body in charge of pharmacovigilance.

In the Friday, May 5, 2006, issue of the Daily Graphic, the FDB published an announcement to the effect that, “Following the designation of the Food and Drugs Board as the National Centre for Pharmacovigilance by the Minister of Health, the board has put in place appropriate structures to monitor the safety of all medicines licensed for use in the country.”

According to Mr Agyarko, the power to designate the centre rested with the minister and once he had made that pronouncement, the FDB was now the NCP.

Dr Dodoo, however, contested Mr Agyarko's claims, saying that much as the minister had the power to designate the centre, he had not officially informed the CTCPT about that decision, pointing out that the CTCPT was still the only recognised institution by the World Health Organisation (WHO) for pharmacovigilance in Ghana.

He said even if the minister informed the CTCPT about the redesignation, it ought to be done fairly and reasonably in accordance with Article 296 (a) of the Constitution, otherwise the UGMS could even take legal action against the minister.

Article 296 of the Constitution provides that, “Where in this Constitution or in any other law discretionary power is vested in any person or authority, (a) that discretionary power shall be deemed to imply a duty to be fair and candid.”

Dr Dodoo made it clear that if the CTCPT was satisfied with the redesignation of the pharmacovigilance centre, it would inform the WHO about the change but indicated that that would not stop it from continuing with research on pharmacovigilance.

Giving the rationale for redesignating the pharmacovigilance centre to the FDB, Mr Agyarko said the centre was established in 2001 through the collaboration of the FDB and the CTCPT.

He said the CTCPT was required to provide technical support in the form of research, while the FDB provided the budget, training, equipment and other resources for the running of the centre. Moreover, the NCP was supposed to send reports of its research to the FDB.

Unfortunately, he said, the centre had not been sending any report to the FDB but chose to send them to international bodies and that “leaves much to be desired”.

Dr Dodoo contested some of the assertions made by Mr Agyarko, such as the collaboration in setting up the NCP.
According to him, the CTCPT took the initiative in 2000 to set up the centre before the FDB later came on board as a collaborator.

He produced a letter, dated June 13, 2000, and signed by a former Deputy Minister of Health, Dr Moses Adibo, giving recognition to the CTCPT as the NCP, to buttress his claim.

He said by being a member of the Uppsala Monitoring Centre (UMC) of the WHO, Ghana was required to send reports to the centre.

Mr Agyarko, however, expressed the opinion that it was better to seek the national interest first before that of international bodies.

He cited an instance when he attended an international conference only to hear reports about Ghana which he, as the Chief Executive of the FDB, was not aware of.

Dr Dodoo denied that accusation, explaining that as a consultant, he held certain views about pharmacovigilance issues in Ghana which he might express at international conferences but that did not constitute sending reports about the country outside.

One other bone of contention is the independence or otherwise of the NCP. According to Dr Dodoo, designating the FDB as the NCP was not the best practice, since that would undermine its independence because the FDB would then become the player and the referee at the same time.

Mr Agyarko disagreed with that assertion, arguing that out of the about 80 members of the UMC, only six countries had their pharmacovigilance centres outside the regulatory body. Therefore, he did not see why anyone could convince him to follow the six and not the 74 majority.

He said with the new designation, what the FDB sought to do was to streamline and co-ordinate the process of pharmacovigilance to bring about sanity.

Mr Agyarko said any institution could undertake pharmacovigilance activities and, therefore, insisting on independence could create a chaotic situation.

That was why there was the need for the regulator to co-ordinate all such activities, since it was the only body which had the right to make pronouncements on research findings on pharmacovigilance.

Dr Dodoo also claimed that there were about 20 countries whose pharmacovigilance centres were independent of their regulatory bodies, adding that in Africa alone, there were five countries, including Ghana, whose pharmacovigilance centres were independent of their regulatory agencies.

He underlined the need for a system which conformed with best practices and pointed out that it was unfortunate that at a time Ghana when had gained global respect and honour in its pharmacovigilance practice, a decision was being taken to redesignate the centre.