Ad-hoc policy of the confused drug regulator

Published April 26, 2021
A brand name is the name given to a pharmaceutical product by its manufacturer. ─ AFP/File
A brand name is the name given to a pharmaceutical product by its manufacturer. ─ AFP/File

A letter sent to the provincial health departments by the Drug Regulatory Authority of Pakistan (Drap), advising them to take necessary measures to stop government and private doctors from prescribing branded medicines and instead write salts/chemicals, is but reflective of the deep- rooted policy ad hocism and confusion prevalent at the regulator.

The letter sent by Drap pharmacy services director Dr Abdur Rashid, mentions that the regulator has received public complaints that the doctors prescribe branded medicines under the influence of pharmaceutical companies, which puts an unnecessary financial burden on the patients.

“This practice adds to the economic burden of the country and also puts a financial load on patients owing to purchase of pricier brands… and is also against the code of ethics for the medical and dental practitioners. You are, therefore, requested to take necessary measures for promoting generic prescriptions by the doctors to discourage the practice of incentivised prescription in the best interest of the patients and the country,” the letter leaked to the media last week stated.

The apparent objective of the Drap ‘advice’ to the provinces is to break the nexus between the pharmaceutical manufacturers and the doctors, as well as to free the patients from the burden of buying expensive branded drugs, especially when their much cheaper alternates are also available in the market. The letter also implies that doctors prescribe more expensive branded medicines for monetary and other benefits from the manufacturers of those drugs.

‘Drap is not ready to trust a doctor but is ready to put its trust in chemists’

The section of the Drug Act of 1976 dealing with the registration of drugs, a report quoted by the Drug Lawyers’ Forum president Noor Mahar, provides that ‘a single-ingredient drug containing one active ingredient shall be registered generally by their generic names while a compound drug containing more than one active ingredient shall be registered generally by their proprietary names’. “However, the doctors in connivance with the pharmaceutical companies write even single-ingredient drugs with their brand names in violation of the regulatory law,” he argues.

A brand name is the name given to a pharmaceutical product by its manufacturer. The use of this brand name is reserved exclusively to its owner as opposed to its generic name. A brand name may also be used for generic products. Hence, we have branded generics. A generic medicine is a pharmaceutical product usually intended to be interchangeable with the originator brand product manufactured without a license and marketed after the expiry of the patent or other exclusive rights. Generics can also be marketed as branded generics under a non-proprietary name or occasionally another approved name.

A similar decision was taken in 1975 but it had proved to be a complete failure. Pakistan Pharmaceutical Manufacturers Association (PPMA) chairman Tauqeer ul Haq says the Drap suggestion is not workable because the doctor decides a medicine to be given to a patient on the basis of his disease, needs and condition. “The doctor selects a particular brand based on his experience and confidence in that brand. So both his experience and brand reputation play an important role in his prescription decisions,” he argues. Moreover, he added, there is a shortage of qualified, trained pharmacists. He fears that the implementation of the suggestion could be harmful to patients’ health because it would encourage cheaper, substandard medicines in the market.

The Pakistan Medical Association (PMA) has also opposed the move saying such issues are beyond the domain of Drap. It believes that the ‘advice’ is neither beneficial for patients or the public. It will open the doors of corruption for medical stores, PMA secretary-general Dr S M Qaisar Sajjad says. “The store owners will sell the products of their choice for more profits. This will establish a symbiotic relationship between the chains of sellers and will never benefit the public. Instead of involving itself in such controversies, Drap should rather try to regulate the industry for quality, efficacy and standardised medicine manufacturing.” A senior doctor working for the Punjab government points out that Drap has no legal right to regulate medical prescription or practice. “Even the Food and Drug Authority does not have such powers,” he said, speaking on the condition of anonymity.

Ayesha Tammy Haq, executive director of Pharma Bureau, the body representing foreign pharmaceutical companies operating in Pakistan, seconds the PPMA chairman’s views. “Only a doctor who goes through rigorous training is qualified to write prescriptions, particularly so in a country like Pakistan where most staff at the pharmacies, medical and general stores do not have the necessary qualification and training to do so.” In answer to another question, she says she is not aware of any country where doctors prescribe salts used in medicine. “Such an action would pose huge risks for the patients and encourage unethical elements to exploit this by incentivising sales staff to sell particular brands. Drap is not ready to trust a doctor but is ready to put its trust in chemists, who are the link between the prescriber and the companies. How come a doctor is not to be trusted

but a chemist can be trusted?” She is of the view that Drap should refrain from making such decisions in haste, especially when there’s also a challenge of writing salt-based prescriptions for combination molecules. According to her, all brands have by law the generic names mentioned on their packing.

Amjad Ali Jawa, former chairman of PPMA, is of the view that the suggestion to prohibit doctors from prescribing branded drugs and writing chemicals or generic formula is not the solution to the issue of the health cost burden on patients. “The real villain here is Drap itself. It has never implemented its own drug pricing policy: one molecule one price. Consequently, we have a massive difference in the price of the same medicines sold under different brand names.

For example, a chemical by the generic name of Memantine used by aged persons for controlling memory loss is available in the market in the price range of Rs460 to Rs9,000. This is because Drap does not follow its own ‘one molecule one price’ formula,” he argues.

According to him the implementation of uniform maximum retail prices of medicines could help bring down the health costs without the need to control doctors’ prescriptions. “Drap gives different prices for one molecule to different brands on the pretext that the better quality brands should get higher rates. If a manufacturer isn’t producing quality medicines or is marketing substandard drugs, the job of the regulator is to shut it down instead of discriminating between different brands while determining the prices of its products.” He said the government had twice in June 1993 and February 2002 approved uniform maximum retail prices for 821 medicines based on the one molecule one formula basis. “But Drap bureaucracy never let it work because of their own vested interests.”

Published in Dawn, The Business and Finance Weekly, April 26th, 2021

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