Thursday, May 30, 2024

Pill for Pharmas

To prevent unethical practices in the sector, the centre has instituted a code which prohibits companies from conducting CME workshops abroad and making it mandatory for them to share expense details

On March 12, the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers issued a notification introducing a new code that imposes restrictions on pharmaceutical companies. Under the Uniform Code for Pharmaceuticals Marketing Practices (UCPMP) 2024, these companies are now prohibited from providing gifts and travel perks to healthcare professionals or their families. This is an initiative to curb misleading promotional activities and ensure responsible marketing practices. The Code also forbids the distribution of free samples to individuals who are not authorised to prescribe the product.

According to the Code, as per the Ethical Criteria for Medicinal Drug Promotion, endorsed by the World Health Assembly in 1988, “promotion” refers to all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medical drugs.

The promotion of a drug must be consistent with the terms of its marketing approval and it cannot be done prior to the receipt of the approval from a competent authority authorising its sale or distribution. Information about drugs must be balanced, up-to-date, verifiable and must not mislead either directly or by implication. It should accurately reflect current knowledge or responsible opinion and must be capable of substantiation, which must be provided without delay at the request of the members of the medical and pharmacy professions, including members of other professions employed in the pharmaceutical industry.

As per UCPMP 2024, claims for the usefulness of a drug must be based on up-to-date evaluation of all available evidence. The word “safe” must not be used without qualification, and it must not be stated categorically 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. Comparisons of drugs must be factual, fair and capable of substantiation. In presenting a comparison, care must be taken to ensure that it does not mislead by distortion, by undue emphasis, by omission, or in any other similar way. Brand names of products of other companies must not be used in comparison unless the prior consent of the companies concerned has been obtained. Other companies, their products, services, or promotions must not be disparaged either directly or by implication. The clinical or scientific opinions of healthcare professionals must not be disparaged either directly or by implication.

The Code mentions textual and audio-visual promotion. It says that any promotional material issued by an authorised holder, or with his authority, must be consistent with the requirements of this Code. The purpose of the material is to provide persons qualified to prescribe the drug with sufficient information to reach a decision for prescription or for use. Promotional material such as mailings and journal advertisements must not be designed to disguise their real nature. Where a pharmaceutical company pays for, or otherwise secures or arranges the publication of some promotional material in journals, the promotional material must not resemble the editorial matter. Promotional material must conform, both in text and illustration, to canons of good taste and must be expressed to recognise the professional standing of the recipients and not likely to cause offence. The names or photographs of healthcare professionals must not be used in promotional material.

In addition, promotional material must not imitate the devices, copy slogans or general layout used by other companies in a way that is likely to mislead or confuse. Wherever appropriate, the date of printing, or of the last review of promotional material must be stated. Postcards, other exposed mailings, envelopes or wrappers must not carry matter which might be regarded as advertising to the lay public, or which could be considered unsuitable for public view. Audio-visual material must be supported by all relevant printed material so that all relevant requirements of this Code are fully complied with.

Coming to Continuing Medical Education (CME), the Code says: that engagement of the pharmaceutical industry with the healthcare professionals for CME, Continuing Professional Development (CPD) or otherwise for conference, seminar, workshop, etc., should only be allowed through a well-defined, transparent and verifiable set of guidelines. Such activities or events should operate within the following framework:

(i) Conduct of such events in foreign locations is prohibited.

(ii) The following are allowed to conduct CME/CPD meetings: medical colleges/teaching institutions/universities/hospitals; professional associations of doctors/specialists; NIPERs, laboratories of ICMR, DBT, CSIR, etc., pharma colleges/other academic and research institutions and pharmaceutical companies, including their trusts/associations, either alone or in collaboration with professional bodies, institutions.

(iii) All pharmaceutical companies should share the details of such events conducted by them, including the expenditure on their website, and may be subject to independent, random, or risk-based audit for this purpose.

(iv) All organisers of such events should explicitly spell out the procedure followed in the selection of participants and speakers, display a statement of their funding sources and expenditure on their website, and may be subject to special audit for this purpose.

(v) Entities incurring expenditure on such events, as well as participants and speakers, must comply with the relevant provisions of the Income Tax Act 1961 as amended from time to time.

Coming to the relationship with healthcare professionals, the Code says that no gift should be offered or provided for personal benefit of any healthcare professional or family member (both immediate and extended) by any pharmaceutical company or its agent i.e. distributors, wholesalers, retailers, etc. Similarly, no pecuniary advantage or benefit in kind may be offered, supplied, or promised to any person qualified to prescribe or supply drugs, by any pharmaceutical company or its agent i.e. distributors, wholesalers, retailers, etc.

Companies or their representatives, or any person acting on their behalf, should not extend travel facilities inside or outside the country, including rail, air, ship, cruise tickets, paid vacations, etc., to healthcare professionals or their family members for attending conferences, seminars, workshops etc., unless the person is a speaker for a CME or a CPD programme.

Companies or their representatives should not extend hospitality like hotel stay, expensive cuisine, resort accommodation etc., to healthcare professionals or their family members (both immediate and extended) unless the person is a speaker for a CME or a CPD programme.

Companies or their representatives should not pay cash or monetary grants to any healthcare professional or their family members (both immediate and extended) under any pretext.

In addition, all Indian Pharmaceutical Associations will upload the UCPMP on their website along with the detailed procedure for lodging complaints, which will be linked to the UCPMP portal of the Department of Pharmaceuticals. There will be a committee for handling complaints named as “Ethics Committee for Pharma Marketing Practices (ECPMP)” in each Association, chaired by its CEO. The Committee will have three to five members, and its composition will be approved by the Board of the Association and prominently placed on its website.

If a complaint received in a particular association is not concerned with its members, it will input the abstract of the complaint and transfer the complaint to the association where the respondent company is a member of the other association.

In case of companies who are not members of any association or are members of more than one association, the complaint should be handled by the Pharma Industry Association to whom the complainant has addressed the complaint; and where necessary, it will seek guidance from the Department of Pharmaceuticals. All pharma associations will share on their website the details of complaints received—the nature of complaint, the company against whom the complaint has been made, the present status of the complaint, including action taken by the ECPMP, and such details and these should remain uploaded for five years. Such details should also be uploaded on the UCPMP portal of the Department of Pharmaceuticals.

All complaints related to the breach of the Code should be addressed to the ECPMP, the CEO and the association concerned. All complaints related to an activity of breach of the Code should, to the extent practicable, be made at one time. The complaint must be made within six months of the alleged breach, with a maximum of another six months for reasonable delay that can be explained in writing. Related complaints may be clubbed together by the Ethics Committee to save time and expedite disposal.

Once a complaint is lodged, the process of enquiry should be taken up and completed by the ECPMP. The decision of the Committee will be made by majority. In case of a conflict of interest, the member/s concerned should recuse themselves from the proceedings.

When the Committee receives information that a company may have contravened the Code, the MD or CEO of the company will be asked to provide a complete response to the matter. To assist companies in ensuring that a complete response is submitted, the Committee may suggest to the respondent company the relevant supporting material to be supplied, and it shall be the company’s responsibility to ensure that a full response is submitted within the stipulated time frame, which is not more than 30 days after receipt of notice from the Committee. The company against which the complaint is made should provide supporting evidence even if it thinks that the Code has not been breached.

The Committee should render a decision within 90 days of the receipt of complaint, and having done so it should promptly notify the parties of its decision in writing and send it by mail.  

—By Adarsh Kumar and India Legal Bureau

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