EXPLAINER: Can the pharma ethics code stop malpractices? – Pharma News

The government has notified the new marketing code for pharmaceutical companies to curb unethical practices. Banasree Purkayastha examines the implications of the code on industry practices and the challenges of enforcement

l  Guidelines voluntary, not mandatory

The Uniform Code for Pharmaceuticals Marketing Practices (UCPMP) 2024 lays down a set of guidelines for the conduct of medical representatives, the provision of brand reminders and free samples and relationships with healthcare professionals.
The Code incorporates directives for lodging complaints against unethical marketing practices, handling of unaddressed issues, complaints, penalties and appeals, along with delineating responsibilities of the chief executives of pharmaceutical companies in all such matters. The provisions extend to medical device manufacturers  and the sale and distribution of such products, unless otherwise specified. However, the Code it is not actionable in punitive terms under the law and any adherence to it is purely voluntary.

l  Cleaning up the doctor-pharma link

Acknowledging the undue influence by pharmaceutical companies on doctors, the Code prohibits any kind of gifts, sponsorships or payments by companies or their distributors, wholesalers or retailers to healthcare professionals. Engagement of doctors in consultant-advisory capacity is allowed only for genuine research services, and has to be supported by a consultancy agreement that takes into account provisions of the Income Tax Act on business promotion expenses. Paid travel, hotel stays, etc., cannot be extended by pharma firms. When doctors are invited to conferences or seminars for Continuing Medical Education (CME), the pharma company has to upload all details, including a statement of their funding sources and expenditures, on its website. This will be subject to a special audit.

l  Appeal mechanism for complaints

While all pharmaceutical associations have to establish an Ethics Committee for Pharmaceutical Marketing Practices (ECPMP) which can take action on breach of the Code by an entity, for the first time, the government has introduced an appeal mechanism allowing parties to a complaint on unethical marketing practices to file an appeal with the Apex Committee for Pharma Marketing Practices (ACPMP).

The apex committee will be headed by the secretary, department of pharmaceuticals, and will also have a joint secretary and a finance officer, dealing with the subject, as its members. The ACPMP’s decisions will be final and binding on both the parties, and it can impose penalties or make reference to an appropriate government agency or authority.

l  Putting a stop to tall claims

The UCPMP states that a drug cannot be promoted before its sale in the market has been approved by the authorities. Claims for the usefulness of a drug must be based on up-to-date evaluation of all available evidence. The word ‘safe’ cannot be used without qualification, and no company can claim that a medicine has no side effects, toxic hazards or risk of addiction. The word ‘new’ must not be used to describe any drug which has been generally available or any therapeutic intervention which has been generally promoted in India for more than a year.

l  Reactions from doctors’ groups

The Alliance of Doctors for Ethical Healthcare, a network of physicians campaigning for ethics in medicine, has said that the UCPMP 2024 “would be as useless” as the code released in 2015. “Unhealthy practices by pharmaceutical companies of bribing doctors and giving them freebies add to the cost of drugs which ultimately burdens patients’ pockets,” it said in a statement. The association said  since there is no provision of a hefty fine or any other strong action, the guidelines are in effect only a “window-dressing”.

l  Necessity for punitive action

The Code has tried to maintain a balance between promoting drug discovery and protecting patient rights. The emphasis on compliance with tax laws reflects a shift towards stricter regulatory oversight and the proposed panel of audit firms will help check over-the-top promotional expenses. A self-regulatory mechanism, however, may not be enough in case of serious violations. While any reprimand by the apex committee will have a negative impact on a firm’s reputation, some scope for punitive actions on errant firms is essential.