WHO suggests reforms in pharmaceutical sector

Members of registration panels not required to sign any declaration of conflict of interest

ISLAMABAD: The apex global health body, The World Health Organisation (WHO), in a report on governance in the public pharmaceutical sector, has found that the process of registering medicines, inspection, market control of manufacturers and distribution, clinical trials procurement and distribution of medicines, were all vulnerable to corruption.

The report, “Measuring Transparency to Improve Good Governance in the Public Pharmaceutical Sector in Pakistan”, said that while data about registered medicines were available in the form of notifications, these were circulated after meetings of the Registration Board, but an up-to-date list of registered products was not available.

The report also highlighted the absence of any written conflict of interest guidelines in the medicine registration process.

Moreover, it says that members of registration committees are not required to sign any declaration of conflict of interest.

The report also highlights a lack of transparency and illegal rewards as part of unethical behaviours in medicine registration.

Unchecked promotion

The report noted that the subject of medicine promotion control was highly susceptible to corruption.

Legal provisions on the promotion of medicines encompass advertisement to the public and professionals, packaging, labelling and package inserts. However, the legal provisions do not cover free samples, symposia and scientific meetings (within the country and abroad), post-marketing scientific studies, speaker and consultancy fees, promotion of exported medicines, and restrictions on gifts and other benefits.

Anyone in breach of any provision of the law is liable for imprisonment and fine, but this is generally not enforced satisfactorily.

Moreover, it said that there was no formal procedure for reporting unethical promotional practices, and no committee was responsible for monitoring and enforcing the provisions on medicine promotion.

Further, there no written guidelines on conflicts of interest with regards to control of advertisement.

The reports identified a number of unethical behaviours in medicine promotion involving both health professionals and health institutions in general and the regulatory office staff and committee members responsible for controlling medicine promotion.

Market control

Inspection and market control of manufacturers and distributors was also found to be vulnerable to corruption.

No written guidelines exist with regard to inspection activities, the report said, adding that there were no written procedures to prevent regulatory capture and no external auditing of inspections was carried out by another country.

However, the Drug Regulatory Authority of Pakistan (Drap) and the provincial Quality Control Board said they have some unwritten procedures to this effect.

Published in The Express Tribune, November 11^th, 2017.