LAHORE: The Drug Regulatory Authority Pakistan (Drap) has notified the newly-approved rules to regulate marketing practices for the pharmaceutical industry all over the country.

Being the front line regulator of pharmaceutical sector, Drap circulated the new rules under the title ‘Ethical Marketing to Healthcare Professionals Rules 2021’ after seeking approval from the federal government.

A notification in this respect has been issued by Drap for the pharmaceutical sector for implementation in letter and spirit.

Under the new rules, complete restriction has been slapped on the pharmaceutical companies against giving “gifts” to the healthcare professionals for prescribing their products (drugs etc) to the patients.

“The companies shall not provide gifts to individual beneficiary healthcare professionals in any shape whatsoever”, reads the notification (A copy is available with Dawn).

Restrictions on gifts, tours for healthcare professionals

It has also re-defined the conditions and mechanism for the healthcare professionals and the companies for foreign tours, accommodation and meal services.

“If it is necessary for the healthcare professional consultant to travel for official services, companies shall pay for or reimburse reasonable expenses of travel, accommodation and meal, subject to the some conditions”, reads the notification.

The expenses shall be limited to those that are necessary for the healthcare professionals for providing the services.

“No expenses shall be paid for spouses or other guests accompanying a healthcare professional,” said the notification.

It says the companies shall make travel bookings directly on behalf of the healthcare professionals on the recommendation or approval by the institution concerned, rather than providing reimbursement to the professionals. The reimbursement shall be only made for actual cost incurred and upon submission of original receipts or other adequate proof of payment, it adds.

It reads the reimbursement shall be made through cheque or electronic bank transfer and companies shall not fund or reimburse any international trip of healthcare professional unless a no-objection letter is received from the employer of a healthcare professional.

The notification further reads that the third-party educational conference, sponsored or conducted by or on behalf of a national professional association or organisation, shall be of an educational, scientific, policy-making nature and for the purpose of promoting scientific knowledge, medical advancement or delivery of effective healthcare.

The companies must not directly pay for or reimburse the expenses of any individual professional delegates to attend a conference and grants must not inappropriately benefit individuals, nor provide for side trips, recreation, entertainment or lavish meals or accommodations.

They shall not provide, organise or pay for recreational or entertainment activities of healthcare professionals, including but not limited to tours, cultural and artistic activities.

About research, educational, charitable grant and donation, it says, the company shall adopt an objective criteria for providing grants and donation.

They shall implement appropriate procedures to evaluate grant and donation requests against the objective criteria and to ensure that they shall not be used as a condition of purchase of the company’s products or to improperly obtain any other form of advantage.

The companies shall not provide grant for inappropriate activities, such as holiday parties or entertainment activities, neither link the grant or donation directly or indirectly to the purchase of medical technologies.

“The companies shall make the payment through electronic bank transfer or cross cheques and cash grants shall not be made”, reads the notification.

They may provide medical technology to an institution free of charge for demonstration and evaluation purposes, provided that demonstration product shall be marked “for demonstration purpose only” in visible font size, or otherwise, to indicate that these are solely for demonstration purposes.

The drug product sample given or supplied to medical practitioners for their clinical evaluation or support shall be subject to additional labeling requirements, such as ‘physician’s sample’, ‘not for sale’ or reduced pack size etc, duly marked with indelible ink and the quantification shall be based on minimum requirement and shall be given to patients free of cost, in compliance with other rules on the subject matter.

It further said the companies shall engage healthcare professionals to provide services which support research and development in medical science, new technologies, improve existing products, services, create awareness about safe and effective use of the company products or enhance the quality and efficacy of patient care.

The Drap has also issued instructions to the companies to devise a mechanism for implementation of the new rules.

They were directed to appoint senior executives to oversee the respective company’s compliance under the given rules, said the notification.

Published in Dawn, November 20th, 2021