Authorities discuss how to implement DRAP rules for breaking pharma-physician nexus

Islamabad: The Health Services Academy (HSA) in collaboration with other health regulatory authorities will launch a pilot project to implement ethical marketing rules for the pharmaceutical companies, which were developed and notified by the ministry of national health services last year, it emerged on Saturday.

“We have offered the regulatory authorities including Drug Regulatory Authority of Pakistan (DRAP), Islamabad Healthcare Regulatory Authority (IHRA) as well as Drug and Food Control Authority of Islamabad to launch a pilot project for implementation of Ethical Marketing to Healthcare Professional Rules 2021 in the federal capital territory”, District Health Officer (DHO) Islamabad Dr. Zaeem Zia told a stakeholders’ meeting at HSA Islamabad.

He was speaking at consultation meeting on ‘Ethical Marketing Practices – Way Forward’ hosted by Health Services Academy (HSA) Islamabad in collaboration with Royal Danish Embassy in Islamabad. The meeting was attended by officials from DRAP, Ministry of National Health Services, Regulations and Coordination, Islamabad Healthcare Regulatory Authority (IHRA), Pakistan Medical and Dental Council (PMDC), officials from the Danish Embassy and HSA Vice Chancellor Prof. Shahzad Ali Khan.

Dr. Zaeem Zia said they were already implementing several other federal laws and rules in the capital as pilot projects and added that with the help of other healthcare regulatory authorities, ethical marketing practices in the pharmaceutical sector could also be promoted in the capital, which could later be replicated by the provinces.

Vice Chancellor, HSA Prof. Shahzad Ali Khan said ethical marketing practices were being followed in the developed world where regulators were very strict in safeguarding the interests of the patients and added that in Pakistan too, ethical marketing practices rules could be implemented if the regulatory authorities including the DRAP and other bodies start enforcing the rules.

Offering the technical support in the implementation of ethical marketing rules for the pharmaceutical companies and healthcare professionals, Prof. Shahzad Ali Khan said in the absence of patients’ rights groups and organizations in Pakistan, it was the responsibility of the Universities like HSA and others to raise the issues facing common people and patients, who were suffering due to pharma-physician nexus in the country.

DRAP officials attending the meeting said it is now mandatory for the all the pharmaceutical companies operating in Pakistan to submit a certificate with the Drug Regulatory Authority of Pakistan (DRAP) annually stating that they have not done anything unethical to promote their medicines in the country, DRAP officials said on Saturday.

“As per Ethical Marketing to Healthcare Professionals Rules, 2021, which are notified last year, all the pharmaceutical companies have to certify to the DRAP that they have not done anything unethical for the promotion of their therapeutic products. Similarly, each company should provide details of all expenditures incurred on institutions or healthcare professionals on account of marketing, honoraria, travel, subsistence expenses, grants and any other related financial transaction to the tax authorities as well as to the DRAP on annual basis”, Akhtar Abbas, Director Licensing DRAP said.

The DRAP’s director licensing maintained that as per notified rules complete, there is a now a complete ban on giving “gifts” to the healthcare professionals by the pharmaceutical companies for prescribing their products including medicines to the patients, adding that companies are not supposed to provide gifts to individual beneficiary healthcare professionals in any shape whatsoever.

The rules further say that it it is necessary for a healthcare professional consultant to travel for official services, companies shall pay for or reimburse reasonable expenses of travel, accommodation and meal, subject to some conditions, the DRAP official said adding that no expenses shall be paid for spouses or other guests accompanying a healthcare professional.

He maintained that although pharmaceutical companies were bound to provide details of all the expenditures on promotion and marketing of their therapeutic products, it was not easy for the DRAP to get the data and details of expenses incurred on marketing of the medicines but hoped that with the passage of time, companies would start complying with the rules.

“At the moment, most of the companies and people don’t even know about existence of any such rules. So, we are trying to create awareness about these rules and ethical marketing practices. At the same time, a committee is being formed to implement these rules and take action against the violators”, he added.

To a query, he said unlike other countries of the world, no patients’ organizations exist in the country to safeguard the interests of the patients and protect their interests in Pakistan. Chief Drug Inspector ICT Sardar Shabir Ahmed, Aslam Pervez from the Royal Danish Embassy Islamabad and others also presented their recommendations and offered their support.