INTRODUCTION
The Uniform Code for Pharmaceutical Marketing Practices (hereinafter referred to as ‘UCPMP’) 2024 was released by the Department of Pharmaceuticals (‘DoP’) on March 13, 2024, for All Pharmaceuticals Association (hereinafter referred to as Association). The Code was the initiative of the Ministry of Chemicals and Fertilizers and the said Code seeks to curb misleading promotional activities and ensure responsible marketing practices within the Pharmaceutical Sector.
UCPMP 2024 outlines acceptable and impermissible activities for morally promoting drugs and considering the complaints regarding unethical marketing practices by pharmaceutical companies. It encompasses various critical subjects such as what should be the conduct of medical representatives (‘MRs’), the provision of brand reminders and free samples, Continuing Medical Education (‘CME’), and associations with Healthcare Professionals (‘HCPs’).
According to Mr. Sudarshan Jain, secretary general of the Indian Pharmaceutical Alliance (IPA), which is made up of major pharmaceutical companies, "the announcement of UCPMP 2024 creates a framework for communication claims, educational activities, samples, and other market initiatives within the knowledge-driven pharmaceutical industry. It explains in detail what actions are allowed and provides a complaint process that involves the Department of Pharmaceuticals and industry associations. It is, in fact, a positive step for the industry, emphasizing the need for better patient care while following accepted conventions.”
The new Code has urged all the associations to constitute an Ethics Committee for Pharmaceutical Marketing Practices set up a specific UCPMP portal on their respective website, and take other essential actions for the code's application.
LANDMARK FEATURES OF THE CODE
Marketing Approval from the Competent Authority- According to the UCPMP, advertising for pharmaceuticals must adhere to the conditions of the marketing approval. Additionally, advertising cannot take place before the appropriate authorities have accorded market approval for the sale or distribution of the drug. (Section 1.2 of the Code).
Verified and Substantiated Information about drugs should be circulated- The new Code prescribes that any information related to drugs must be verified, and up to date and should not mislead or create any confusion either directly or indirectly moreover, the information should reflect current knowledge or responsible opinion. (Section 1.3 of the Code).
No personal benefit to the healthcare professionals by the Pharma Companies - Right at the outset, the UCPMP outlines that no pharmaceutical company or its agent should offer any presents for the peculiar benefit of any healthcare professional, including his/ her family. Additionally, it prevents companies and their agents from offering any pecuniary advantage or in-kind benefit to any individual who is qualified to prescribe or supply the medications. (Section 8.1 of the Code) Not only this, but the new code also confines the Companies to cover travel facilities for attending sessions, seminars, workshops, etc. to any professionals (unless the person is a speaker for a CME or a CPD Program), and hospitality like hotel stay, luxurious cuisine, resort lodgings. (Section 8.3 of the Code)
Establishment of Ethics Committee for Pharmaceutical Marketing Practices -By virtue of this code, all the pharmaceutical associations have been asked to establish an Ethics Committee for Pharmaceutical Marketing Practices (‘ECPMP’) which will be chaired by the CEO and will consist of three to five members. This composition will have to be then placed on the website of the said association. (Section 9 of the Code)
KEY HIGHLIGHTS
Regulated Claims and Comparisons - Section 2 of this Code
The new Code clarified that the Pharma businesses must use the most recent and up-to-date data to support their claims regarding the efficacy of their products. It further prescribes that the drug comparisons need to be fair and factual, without criticizing rival companies or their goods.
It is also intriguing to note that UCPMP also introduced the use of the words 'safe' and 'new' within the pharmaceutical sector. It was highlighted that the word "safe" must not be used without qualification. Following this, it must not be downright stated that a particular medicine does not have any kind of side effects, toxic hazards, or risk of addiction. Similarly, the word "new" must not be used to define any drug which is normally/usually available.
Regulation pertaining to Brand Reminders from the Pharmaceutical Companies to Healthcare Practitioners- Section 5 of this Code
With certain bounds, promotional materials such as informational and educational items (that include books, calendars, diaries, journals, and dummy device models) and free samples that serve as brand reminders are acceptable within the provisions of this Code. To prevent undue effect on prescription behavior, their distribution is highly monitored, for example, the Free Samples of drugs shall not be supplied to any person who is not qualified to prescribe such product. Section 5 stipulates the conditions that have to be observed while providing samples to a person who is qualified to prescribe such products.
Continuing Medical Education CMEs -Section 6 of the code
In a similar vein, the new Code also controls interactions of the pharmaceutical industry with healthcare professionals during activities which are conducted for Continuing Medical Education (CME) or Continuing Professional Development (CPD) such as conferences, seminars workshops, etc. The CME/CPD event framework allows medical colleges, professional groups, research institutions, and pharmaceutical corporations to host such seminars or workshops, however, the new code sets out a set of guidelines based on which the members and professionals can undertake the expenditures for such seminars or workshops. The guidelines are set out herein:
Conduct of such events is prohibited in foreign locations;
All pharmaceutical companies should share the details of such events conducted by them, including the expenditures incurred thereupon, on their website. Additionally, such companies may be subject to an independent, random, or risk-based audit for this purpose;
Companies should disclose event specifics, and organizers should be open and honest about their selection procedures. Everyone who is participating must abide by the Income Tax Act of 1961.
Relationship of Pharmaceutical Companies with Healthcare Profession- Section 8 of this Code
The UCPMP prohibits pharmaceutical companies and their agents from offering gifts, or benefits in kind to healthcare professionals or their family members. Similarly, travel facilities including rail, air, ship, cruise, pecuniary advantages, hospitality, and monetary grants are restricted, except when healthcare professionals are speakers for Continuing Medical Education (CME) or Continuing Professional Development (CPD) programs.
This section provides a disclaimer that states that if any item is missing in the Code, then the corresponding provision in the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation 2002 will prevail.
Logging of complaint – Section 10 of the code
Complaints to be registered with ECPMP- This section outlines the procedure for filing of the complaints which could be lodged in case any company breaches the requirements envisaged under this Code. Complaints must be addressed to the Ethics Committee for Pharma Marketing Practices (ECPMP) of an association, ideally within six months of the alleged breach, which can be extended to another 6 months if the Company can explain the reasonable delay.
Contents of the Complaint- Any Complaint that is registered with ECPMP should be in writing, should identify who the ‘complainant’ is, should describe the alleged company that committed the breach, and should encompass all the details pertaining to that breach. The said Complaint has to be accompanied by a non-refundable fee of Rs. 1,000/-.
Who can file the Complaint- The code provides that if the Complaints are from pharmaceutical companies, the Companies will require authorization from higher management. Media reports suggesting breaches on the part of any pharma companies can also be treated as complaints. Any Complaints that are directly received by the DoP can be forwarded to the respective associations of these Companies for further action on their behalf.
Handling of Complaints- Section 11 of this Code
Enquiry to be conducted- Once a complaint is lodged, ECPMP will conduct an inquiry and will arrive at a decision by majority vote however whenever there is a conflict of interest, the members of ECPMP can recuse themselves from the proceedings/inquiry. Upon receiving information indicating a potential code contravention, the concerned company's management will be asked for a complete response, with the Committee guiding necessary supporting materials. Professional auditors may assist associations of the Company in the examination process.
Response on behalf of the Respondent Company- The Respondent Company must submit comments and documents within 30 days, even if it believes no such breach has occurred. The Committee has to render a decision within 90 days, notifying parties in writing. If no breach is found, the complainant is advised accordingly, with guidance on alternative forums. If a breach is confirmed by the Committee after the inquiry, the Complainant and the Respondent Company will be advised in writing.
Final decisions, binding on association membership will have to be uploaded on the association as well as the Department of Pharmaceuticals' websites if no appeal is made within the specified period.
Other directives issued under the code
The Code incorporates directives for lodging complaints; handling unaddressed issues, complaints, penalties, references, and appeals, along with delineating the responsibilities of pharmaceutical company CEOs.
The ECPMP formed in each association can initiate appropriate actions such as deferment or dismissal of the Company from the Association, and can take other counteractive actions once it is established that a breach of the provisions of the Code has been made by a Company. In cases where disciplinary, punitive, or remedial action falls within the jurisdiction of government agencies, the Committee may send its references to the relevant authorities through the DoP.
The Code also announced a mechanism for filing the appeal against the companies who committed the breach, allowing parties to the complaint to file an appeal with the Apex Committee for Pharma Marketing Practices (‘ACPMP’) in cases of discrepancy with the decision of the ECPMP on the grounds of the lack of decision or an unwarranted delay. The ACPMP may either suggest any penalties or make reference to an appropriate government agency or authority. The decision considered during the time of the appeal shall be final and mandatory for both the parties.
The Chief Executive Officers of pharmaceutical companies bear responsibility for confirming compliance with the provisions of the Code and are required to submit a self-declaration in a given format within a period of two months of the end of every financial year, to the Association, for uploading on their website, or directly on the UCPMP portal of the DoP, in case the CEO is not a member of such a body, or a member of more than one such bodies.
Is the Code Mandatory and overrides any existing laws?
It is significant to mention that a similar Code with the title of the Uniform Code of Pharmaceutical Marketing Practices was published by the Ministry of Chemicals in the year 2014 wherein the quid pro quo practice between doctors and pharmaceutical companies was specifically prohibited. However, the provisions prescribed therein were 'voluntary' for the practitioners to follow which subsequently impacted the implementation of the said Code. The present Code has not specifically mentioned whether its provisions are voluntary for the practitioners or members and the same has to be consequently determined with the further implementation of this Code.
The Code does not prescribe anything which suggests that it overrides the any existing act and regulation, however the provisions of the Code to some extent provides that the pharma companies should provide balanced up to date information regarding the drugs and urged companies to take up ethical practices for promotion and advertisement of the drugs. Recently in the case of Indian Medical Association vs. Union of India W.P. (C) No. 000645 of 2022, the Petitioner Indian Medical Association filed the case against the Company Patnajali for issuing misleading advertisements that claimed cure for several ailments. It further highlighted that while every commercial entity has the right to promote its product, there should be restricting on making unverified claims in the name of production. Such claims were considered in direct violation of laws such as Drugs and Other Magic Remedies Act, 1954 and Consumer Protection Act. The same kind of promotion is also restricted within the provisions of the new law. Hence, it is yet to be determined whether this remedy will be co-existing or will override the provisions of the existing acts which already reprimand spreading misleading information by the companies including the pharma companies.
CONCLUSION AND WAY FORWARD
The introduction of this uniform marketing code represents a pivotal moment in the ongoing evolution of the pharmaceutical industry. By establishing comprehensive guidelines and standards for marketing practices, the code lays the foundation for a more ethical, transparent, and patient-centered approach to pharmaceutical promotion.
Through its emphasis on ethical promotion, transparency, and patient-centricity, the code reaffirms the industry's commitment to upholding the highest standards of integrity and professionalism. By providing clear guidance on acceptable marketing practices and promoting accountability through robust compliance and enforcement mechanisms, the code aims to restore and strengthen trust among healthcare professionals, patients, and the public.
As we move forward with the implementation of the code, all stakeholders need to remain actively engaged in its execution and enforcement. Pharmaceutical companies must demonstrate their commitment to compliance and ethical conduct, while regulatory agencies, healthcare professionals, and patient advocacy groups play vital roles in monitoring adherence to the code and holding violators accountable.
Ultimately, the success of the uniform marketing code will depend on the collective efforts of all stakeholders to uphold its principles and promote a culture of integrity within the pharmaceutical industry. By working together collaboratively, it can ensure that the code achieves its intended objectives and serves as a catalyst for positive change, fostering trust, transparency, and ethical marketing practices that benefit patients and society as a whole.
The above article is authored by Ms. Bheeni Goyal, Senior Associate(Designate).
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