Déjà Vu, Déjà Do Something! Make UCPMP-2024 a Legislative Reality!
- Preamble
- History of UCPMP
- Hopes with UCMP-2024
- Conclusion
Preamble
In the landscape of pharmaceutical marketing ethics, the UCPMP (Uniform Code of Pharmaceutical Marketing Practices) has been a cornerstone, albeit with limited efficacy.
The inception of UCPMP-2014 as a voluntary framework aimed to instil Good Marketing Practices within the Indian pharmaceutical industry, yet its lack of enforcement mechanisms rendered it toothless against transgressions.
Fast forward to March 2024, the emergence of UCPMP-2024 introduces notable revisions, including mandatory disclosure of expenses for medical promotion and grants to healthcare professionals.
While these changes signify progress, the efficacy of such voluntary measures remained debatable.
History of UCPMP
This editorial delves into the evolution of UCPMP and explores the necessity for more robust legal frameworks to truly deter unethical practices within the pharmaceutical sector.
On December 12, 2014, the central government introduced the Uniform Code of Pharmaceutical Marketing Practices (UCPMP-2014), intended for voluntary adoption and adherence by pharmaceutical enterprises concerning marketing activities. It was explicitly stated that failure to effectively implement the code by pharmaceutical associations/companies could prompt the government to enact it as a statutory provision.
Despite the initial stipulation of a six-month duration for the UCPMP-2014, subsequent extensions by the Department of Pharmaceuticals (DoP), totaling five instances, culminated in the extension of the UCPMP Code, 2014, until further directives were issued on August 30, 2016. This series of extensions suggested a lack of enthusiasm on the part of the DoP towards the implementation of the UCPMP-2014.
The implications for the pharmaceutical industry were unequivocal, as evident from the prevailing circumstances.
In the year 2021, the Federation of Medical and Sales Representatives Association of India, functioning as a non-governmental organization (NGO), lodged a petition with the Supreme Court of India. Their plea sought the formulation of comprehensive directives aimed at curbing unethical marketing strategies employed by pharmaceutical entities. This petition was made with the intent to fill the regulatory void until the enactment of specific legislative measures by the Parliament. Presently, the case remains under consideration by the Court, awaiting its final adjudication.
The UCPMP-2014 aimed to create a level playing field for pharmaceutical companies, encouraging innovation and patient-centered marketing practices. However, practical challenges must be addressed for effective enforcement. Stricter regulations covering indirect influences, and robust oversight mechanisms are essential to achieving UCPMP’s objectives and promoting ethical practices in pharmaceutical and medical devices marketing.
The UCPMP-2014 had the intent of fostering equitable conditions among pharmaceutical companies, fostering innovation, and advocating for patient-centric marketing methodologies. Nevertheless, the realization of its objective’s hinges upon the resolution of pragmatic hurdles. Enforcing its provisions effectively necessitates the implementation of more stringent regulations encompassing indirect influences, alongside the establishment of robust oversight mechanisms. These measures are imperative for ensuring the attainment of UCPMP-2014 goals and fostering a culture of ethical conduct within the realms of pharmaceutical and medical devices marketing.
The Department of Pharmaceuticals (DoP) issued a new policy on March 12, 2024. This policy, known as the Uniform Code for Pharmaceutical Marketing Practices (UCPMP-2024), establishes guidelines for the ethical promotion of pharmaceuticals. The DoP directed all pharmaceutical associations (like IPA, OPP; IDMA) to disseminate the UCPMP-2024 to their members and ensure its strict compliance.
The UCPMP-2024 outlines acceptable practices for activities such as interactions with healthcare professionals, distribution of informational materials, and providing samples. It also establishes a framework for addressing unethical marketing practices. This policy aims to promote ethical conduct within the pharmaceutical industry.
Hopes with UCMP-2024
UCPMP-2024) establishes ethical guidelines for drug promotion. It defines acceptable activities for medical representatives, brand materials, samples, and interactions with healthcare professionals. Additionally, it provides a framework for addressing unethical marketing practices.
Here are some of the key and the new features of UCPMP-2024.
- Conduct of pharmaceutical and medical devise representatives: Pharmaceutical and medical devise representatives must strictly adhere to ethical guidelines. Misleading or exaggerated claims are prohibited, promoting accurate information dissemination about the product’s benefits and potential side effects.
- No gifts and incentives: Gifts, incentives, or any form of personal benefits from pharmaceutical and medical devise entities to healthcare professionals or their families are strictly prohibited. This includes travel, hospitality, or financial inducements that may influence prescription decisions.
However, exceptions are made for educational items such as books, calendars, and clinical guidelines, provided their value does not exceed Rs. 1000 and they serve professional purposes without independent commercial value.
Additionally, this means medical professionals can receive travel and hospitality support for participating as speakers in Continuing Medical Education (CME) or Continuing Professional Development (CPD) programs. These measures aim to maintain the integrity of healthcare decision-making processes and ensure that medical professionals prioritize patient welfare over personal gain.
- Continuous Medical Education: This fosters medical professional’s development. UCPMP-2024 establishes clear guidelines for Continuing Medical Education (CME) and Continuing Professional Development (CPD) programs.
These programs must be held within the country and can be organized by pharmaceutical companies independently or collaboratively.
Companies sponsoring such programs are required to disclose their expenditures on a dedicated website. Additionally, organizers must also publicly display a statement outlining funding sources and the selection process for participants and speakers.
It’s important to note that all parties involved, including the company, organizers, speakers, and participants, must comply with the Income Tax Act (Section 194R) to ensure financial transparency and accountability.
- Support for Research: The UCPMP-2024 regulates interactions between pharmaceutical companies and medical professional for research purposes. The medical professionals’ involvement, in a consulting or advisory role, must be for legitimate research with a formal agreement and appropriate compensation complying with existing regulations.
These interactions must prioritize patients’ well-being and the patient interest is not compromised.
It upholds HCP integrity, adhering to relevant National Medical Commission (NMC) regulations and guidelines. Research must be approved by a competent authority and conducted at a designated location, if applicable.
Expenditure on research by pharmaceutical companies is an allowable expenditure subject to the provisions of the Income Tax Act 1961 as amended from time to time.
- Relationships with medical professionals: The UCPMP-2024 forbids pharmaceutical companies and their associates from offering gifts or financial benefits to healthcare professionals (HCPs) or their families. This extends to both direct and indirect benefits, ensuring ethical interactions and fair prescribing practices.
UCPMP-2024 further restricts pharmaceutical companies or their agents including stockists and distributors from offering travel or hospitality to HCPs or their families, except for approved speakers at Continuing Medical Education (CME) or Continuing Professional Development (CPD) events. This ensures unbiased interactions and discourages undue influence.
The UCPMP-2024 prohibits cash or monetary grants to healthcare professionals or their families.
When it lacks clarity on interactions with HCPs, adhere to the Indian Medical Council Regulations (Professional Conduct, Etiquette, and Ethics) of 2002.
- Additional guidelines: Additional guidelines are integrated into UCPMP-2024, detailing complaint procedures, issue resolution, penalties, and CEO duties in pharmaceutical companies.
The Ethics Committee for Pharmaceutical Marketing Practices (ECPMP) within each association holds authority to take necessary actions its members, such as suspension or expulsion, upon confirming a breach of the UCPMP-2014. When governmental intervention is required, recommendations are forwarded through the DoP.
The UCPMP-2024 establishes a new appeals process. If parties disagree with a decision by the ECPMP, they can appeal to the Apex Committee for Pharma Marketing Practices (ACPMP). The ACPMP has the authority to impose penalties or refer matters to relevant government agencies. Their decision is final and binding on all parties involved.
Under UCPMP-2024 CEOs of pharmaceutical companies are held accountable for following it meticulously. They must submit a yearly self-declaration within two months of their fiscal year-end. This declaration can be uploaded to their industry association’s website or directly to the government’s UCPMP-2014 portal if they are not part of an association.
Conclusion:
In the realm of pharmaceutical marketing, a crucial aspect often overlooked is the integration of a patient-centered approach.
UCPMP-2024, while comprehensive, fails to acknowledge the pivotal role of patient-centricity in promoting healthcare solutions. A patient-centered marketing approach prioritizes the needs, preferences, and well-being of patients above all else.
By fostering open communication, understanding individual experiences, and tailoring solutions accordingly, this approach enhances trust and engagement within the healthcare ecosystem. Empowering patients with information and involving them in decision-making processes not only improves treatment adherence but also fosters a sense of ownership over their health journey.
Incorporating patient narratives, feedback mechanisms, and support networks into marketing strategies can bridge the gap between pharmaceutical companies and the individuals they serve.
Embracing a patient-centered mindset isn’t merely a moral imperative but a strategic imperative for driving sustainable healthcare outcomes and fostering long-term partnerships built on empathy and mutual respect.
Nevertheless, UCPMP-2024 represents a significant advancement in ensuring ethical conduct within the pharmaceutical industry. This code establishes clear guidelines for marketing practices, fostering a more transparent and responsible environment.
We must seriously consider the argument put forth by Sudhansh Pant, a former Joint Secretary at the Department of Pharmaceuticals (DoP). His experience positions him well to assess the potential of public exposure in deterring unethical marketing practices.
The UCPMP-2024 can be significantly strengthened through robust enforcement mechanisms that include the public disclosure of violations. The threat of reputational damage can serve as a powerful motivator for both pharmaceutical companies and medical professionals to adhere to the code’s principles.
The Physician Payments Sunshine Act – USA
The Physician Payments Sunshine Act USA serves as a potential model for nations seeking to promote ethical conduct among medical professionals and responsible marketing practices within the pharmaceutical industry. The Physician Payments Sunshine Act (Sunshine Act), though enacted in 2010, continues to influence marketing practices in 2024. We shall now assess the ramifications of this Sunshine Act on both medical professionals and the pharmaceutical industry of USA.
For Medical Professionals:
- Transparency: Sunshine Act data is publicly available. This means medical professionals must be more mindful of the financial ties they have with pharmaceutical companies.
Excessive industry payments might raise eyebrows about a doctor’s objectivity.
- Accountability: Doctors can review, and dispute data attributed to them. This encourages them to maintain accurate records of industry interactions.
For the Pharmaceutical Industry:
- Scrutiny: Knowing their payments are exposed, pharmaceutical companies are likely to be more cautious about excessive or questionable payments to doctors.
This discourages lavish gifts or sponsorships that might influence prescribing habits.
- Focus on Value: Sunshine Act puts the spotlight on the value a company brings.
Pharma companies might shift their focus towards educational programs, research collaborations, or offering tools that genuinely improve patient care.
The Act’s public disclosure of financial ties between these entities fosters transparency and accountability, ultimately aiming to ensure patient well-being remains the primary focus. It creates a system where financial relationships are exposed, fostering a shift towards interactions based on genuine value exchange and ultimately promoting better practices in the healthcare industry.
In light of the Sunshine Act’s effectiveness, the author proposes the DoP to leverage its strengths when crafting a new legislative framework to supersede the UCPMP-2024. The author contends unequivocally that the UCPMP-2024 should transition from a voluntary initiative to statutory law. This small incremental step paves the way for potentially stronger regulations in the future.