Not only doctors, drug regulators also funded by pharma industry

ISLAMABAD: Pharmaceutical companies are not only financing foreign trips of doctors, an audit of Drug Regulatory Authority of Pakistan (DRAP) has found the officials of drug regulator also involved in this malpractice who are funded by foreign companies.

Right from visa fee, first class air travel and lodging at five star hotels to daily stipend in dollars, all arrangements are afforded by multinational companies wishing to register their medicines with DRAP for their sale in Pakistani market. In 18- month duration between January 2017 to June 2018, as many as 27 DRAP officials went abroad and availed the above-mentioned benefits, according to audit conducted by Directorate General Audit (Federal Government).

Call it a coincidence or something else, the annual import of medicines has increased by US$ 491 million from US$ 309 million to US$ 800 million, according to a DRAP report recently presented before Senate of Pakistan. In contrast, export of allopathic medicine has declined by US$ 180 million – from US$ 220 million to US$ 110 million. Likewise, export of herbal medicines has reduced by US$ 180 million and of surgical goods by US$ 100 million.

“Passport, visa, boarding/lodging, return air ticket, accommodation and all such transports which will be necessary for inspection shall be the responsibility of the applicant. Moreover, daily pocket money US$ 100/- shall be given to the each member of the team prior to proceeding to the inspection…….In case of additional time, balance amount shall be submitted by the applicant…….In case of more than one inspection in different cities of the same country, the inter-city and intra city transport, daily expenses shall be the responsibility of the applicant. Stay of the team shall be at five start hotels,” according to the conditions laid out by DRAP for the multinational companies applying for the registration of their products.

DRAP has formalized the practice of accepting foreign tours from the applicants under the guise of inspection of the concerned product. However, this practice is in progress without any legal cover as it has neither been approved by the policy board nor the regulator itself. Audit para has noted that this “formulation of policy for inspection of manufacturing facilities or the manufacturer abroad by obtaining benefits from the applicants is resulted in a conflict of interest……and this puts to doubt the impartiality and objectivity of the whole exercise.”

Audit has observed that applicant could have been charged extra fee to be deposited in treasury for budgeting such inspections in order to avoid conflict of interest instead of encouraging direct dealing between the inspectors and pharmaceutical companies. DRAP didn’t reply to these observations, according to audit report. However, responding to The News, DRAP said the policy under question was approved well before DRAP was set up and that it was approved by DRAP board in its first meeting of the board held in January 2013 which was revised and modified in 14th and 23rd meetings.

“So far, 88 products of 41 foreign manufacturers have been rejected upon recommendations of inspection panel being non-compliant to parameters of safety, efficacy, and quality thus ensuring provision of safe medication to people of Pakistan which is clear indication that inspections are conducted as per laid down criteria and without any conflict of interest,” DRAP said.

As for as doctors’ sponsored visits are concerned, The News spoke to different people in medical fraternity who said it is an international practice that pharmaceutical companies fund the visits for the conferences abroad commonly called “Continuous Medical Education” aimed at updating the physicians about latest innovations in their respective fields. They agreed some black fish are hands in gloves with pharma industry but majority of doctors are not involved in such practices.

The ongoing practice of visits abroad is also in violation of Esta Code Rules 1964 dealing with the conduct of government servants which prohibits them from such practices. Addressing this question under the title “Acceptance of Foreign Trips Sponsored by Commercial Firms”, Esta Code reads: “It has come to the notice of the government that government servants accept offers of foreign trips through the generosity of parties who have commercial dealings with government departments or autonomous bodies. Besides being unbecoming of a government servant, acceptance of such offers tends to place him under official obligation to the party concerned which is not conducive to good administration. It has, therefore, been decided that government servants should attempt to avoid acceptance of offers of such trips. If in any case it is not considered desirable to refuse such an offer in public interest prior permission of the Establishment Division and the Ministry of Finance should invariably be obtained for its acceptance.”