Uniform Code For Pharmaceuticals Marketing Practices 2024: Navigating Ethical Horizons

In an ever-evolving landscape of pharmaceutical marketing, transparency, integrity, and accountability stand as the guiding stars. Striking a balance between reaching healthcare professionals and consumers effectively while maintaining ethical practices can be challenging. Taking into consideration the problems faced by the stakeholders, the central government released the Uniform Code of Pharmaceutical Marketing Practices to be voluntarily adopted and complied by the pharma industry in 2014. In a recent development, the Uniform Code for Pharmaceutical Marketing Practices 2024 (the 'New Code') was notified by the government, under which it is now mandatory for pharma companies to comply with this code.

The New Code delineates acceptable and unacceptable activities for ethically promoting drugs and addressing complaints regarding unethical marketing practices by pharmaceutical companies. It covers critical areas such as the conduct of medical representatives ('MRs'), the provision of brand reminders and free samples, continuing medical education ('CME'), and relationships with Healthcare Professionals ('HCPs'). Significantly, the provisions of the New Code are also made applicable to medical devices and companies or entities manufacturing or dealing with the sale and distribution of such products. The New Code introduces a stricter approach to holding pharmaceutical companies responsible for any breaches. This shift in emphasis prioritizes greater accountability within the industry. The key differences between the 2024 and 2014 Codes and implications for the industry are enumerated below:

• The 2014 Code emphasized on truthful claims backed with most recent analysis of all available data to ensure accurate and ethical promotion of prescription drugs. The New Code requires the information to be also "balanced", while maintaining the above criteria. Misleading tactics like calling medications completely "new" after being promoted for a year in the market are discouraged. The New Code insists on fair comparisons with other drugs avoiding negativity towards competitors or their products.
• To curb the existing misleading promotional activities and potential conflicts of interest, pharmaceutical companies are prohibited from offering gifts, travel, sponsorships for medical education programs, or any other financial benefit to healthcare professionals or their families. This minimizes the risk of undue influence on prescription decisions. However, exceptions are introduced in the New Code for 'Brand Reminders' which include informational and educational items i.e., books, calendars, diaries, journals (including e-journals), dummy device models and clinical treatment guidelines for professional use in healthcare settings with value not exceeding Rs. 1000 per item, provided such items should not have an independent commercial value for the healthcare professionals. The supplier and the receiver of the Brand Reminders are required to comply with the relevant provisions of the Income Tax Act, 1961 with respect to deductions and reporting of income. This may warrant the receiver and giver to maintain logs on delivery and receipt of the goods transacted and their material value.
• With respect to free samples, the New Code requires the companies to note the name and address of the healthcare practitioner to whom samples of products are distributed. Free samples can only be given to qualified medical professionals who can prescribe the specific medication. It is to be ensured that samples are provided only for the purpose of creating awareness about treatment options and for acquiring experience in dealing with the product. The size of the sample pack is limited to the smallest commercially available size, and the quantity is restricted to a prescribed dosage for a maximum of 3 patients with an annual cap of 12 for each healthcare practitioner. The earlier requirement of procuring a signed and dated request for supply of sample packs has been done away with. The New Code now requires the companies to maintain records of product name, doctor name, sample quantity, supply date, and monetary value. This value is capped at 2% of the company's annual domestic sales. This is to ensure that free samples are used for their intended medical purpose and not diverted for personal gain or commercial sale.

• The New Code dedicates an entire section on Continuing Medical Education ('CME') or Continuing Professional Development ('CPE') programmes. Pharmaceutical Companies are allowed to engage healthcare professionals and incur expenditure for CME, Continuing Professional Development ('CPD') or otherwise for conferences, seminars, workshops, etc., only through a well-defined, transparent, and verifiable set of guidelines. All Pharmaceutical Companies are required to share the details of such events, including the expenditures incurred thereupon, the procedure followed in selection of participants and speakers and a statement of their funding sources and expenditures on their website. Previously, pharmaceuticals companies were prohibited from providing travel facilities for vacations or professional events to healthcare professionals and their families, necessitating that these individuals bear their travel expenses. The New Code allows companies to provide travel and accommodation for those healthcare professionals invited to speak at CME or CPE programmes. However, the conduct of these programmes in foreign locations is prohibited.

• The New Code also details the responsibilities of Pharmaceutical Associations in constituting the Ethics Committee for Pharmaceutical Marketing Practices ('ECPMP') for handling the complaints, Apex Ethics Committee for Pharmaceutical Marketing Practices ('ACPMP') for appeal against ECPMP and various penalty provisions. All complaints regarding a breach should be clubbed together, made within six months, and addressed to the ECPMP with a fee of Rs. 1000. The complainant, the company in breach, and any specific products or activities regarding the breach should be clearly identifiable. Any complaint made by a pharmaceutical company should be signed or authorized in writing by the company's KMPs. For any complaints emanating from media reports, the committee may request the concerned publication for further information, and the source or the correspondent may be treated as the complainant.

• All the Indian Pharmaceutical Associations and UCPMP portal will display the details of all complaints on their website for five years. The earlier requirement of affirming the cessation of promotional activities or retrieval of items distributed in violation of the 2014 Code within five days of decision has been removed. For violations, the Committee can propose public reprimand, issuance of corrective statements in media, suspension from the Association or recovery of money or items in addition to applicable disciplinary and penal consequences.

The New Code marks a significant stride for ethical conduct in the Indian pharmaceutical industry. To thrive under this Code, companies must embrace transparency. Investing in robust compliance programs, prioritizing data-driven marketing, and fostering genuine interactions with healthcare professionals will be key. As technology continues its breakneck pace and artificial intelligence becomes ever more sophisticated, the future holds immense potential for pharmaceutical companies to identify and engage qualified healthcare professionals. It will allow pharmaceutical companies to tailor their interactions, presenting relevant clinical trial opportunities, treatment options backed by the latest research, and educational content targeted to the HCP's expertise. This personalized approach can lead to more meaningful conversations and ultimately improve engagement between pharma and HCPs. Further, companies will be required to modify the terms of appointment of medical representatives to bring it line with the Code. The Chief Executive Officers of pharmaceutical companies will have to submit a self-declaration in the prescribed format within 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 he is not a member of such a body, or a member of more than one such bodies. By promoting transparency and discouraging misleading tactics, the New Code fosters a culture of trust with patients and the public. Furthermore, it creates a fair and level playing field for companies, encouraging them to focus on innovation and development of effective medications, ultimately building a more responsible and trustworthy healthcare ecosystem.