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UNIFORM CODE FOR PHARMACEUTICAL MARKETING PRACTICES 2024:AN ANALYSIS
For quite some time, there has been a noticeable prevalence of unethical promotional practices and relationships between drug promoters and medical professionals in the healthcare industry. This bias has influenced the trade of medicines significantly. Through offering gifts, travel opportunities, monetary grants, and other incentives, medical representatives and promotional agencies have been enticing healthcare professionals to endorse their products. Consequently, competition in the market has become unjust and unfair. Medical professionals have tended to prescribe medications solely based on their promotional interests rather than considering suitable and more affordable alternatives available. This behavior has been perpetuated by pharmaceutical companies seeking to capitalize on the promotion of their products. The dominance of large pharmaceutical companies in promotional efforts has disadvantaged smaller players in the industry. This situation underscores the necessity of establishing stringent codes to foster fair competition in the market.
Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals (Government of India) on 12th march 2024 came up with the “Uniform Code for Pharmaceutical Marketing Practice” (UCPMP) where it addressed to all pharmaceutical associations and provided some guidelines for ethical and smooth running of the pharmaceutical marketing practices. And declared to adhere with the guidelines with strict compliance.
- It has strictly focused upon making the industry an ideal environment for the trade of medicines.
- And it has tried to make some compulsory changes in the current system and is providing a strict framework for a fair and ethical marketing practice.
- Because this industry is directly connected to the lives of people and that is the reason such kind of initiatives are always accepted and appreciated by the concerned public of this nation.
This article focuses upon giving a brief analysis of the Uniform Code for Pharmaceutical Marketing Practices (UCPMP), where we will see its salient features, what was the need for having this code, role of the ethics committee in safeguarding the provisions of this code, the penalties for the breach of this code, the process of appeal.
SALIENT FEATURTES
The code provides us the benefit of transparency and role of ethics in the business, here are some salient features of the UCPMP:
- Ethical promotion – There will be a committee for handling complaints named as "Ethics Committee for Pharma Marketing Practices (ECPMP)" in each Association, chaired by its Chief Executive Officer. 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 (stated in Para 9.2 of the UCPMP).
- Regulated claims and comparison – Pharmaceutical companies will be required to produce up-to-date information regarding the drug they want to promote and use of the words “new” and;
- Professional conduct of MRs – The code strictly talks about the conduct of the medical representatives in terms of promoting the medicines and they must adhere to the provisions of the guidelines stated by the Government in this code.
Also, Medical Representatives are prohibited against the use of inducement to gain access to the medical professionals.
- Transparency in CMEs - There will be a proper mechanism to train and engage the people working in the sector as healthcare professionals for the Continuing Medical Education (CME) or Continuing Professional Development (CPD) with the help of seminars, workshops or conferences.
The code is allowing Medical Colleges/ Teaching Institutions/ Universities / Hospitals, Association of Doctors/ Specialists etc. to conduct such kind of CME/CBD meetings. (Para 6.2(ii)).
The code also prohibits the pharma companies from arranging such CME and CBD meetings as they were performing before.
- Complaint Mechanism - UCPMP has explained that after a complaint has been filed alleging a company violating the code, the process of enquiry will be taken up by the Ethics Committee for Pharma Marketing Practices (ECPMP).
- The code has given instructions that the complaint must be filed within six months of the alleged breach of the code.
- Also, another six months can be granted and condoned if there is a reasonable cause and that cause must be expressed in writing.
- Complaints whose facts are similar can be clubbed together by the ethics committee to save time and make a quick decision.
- Restrictions on promotional activities and pecuniary advantages
The code has explained in clear words that there would be no paid promotions in the form of Gifts, Allowances, Hospitality, Travel, Monetary Grants or any other form of benefit.
EHICS COMMITTEE FOR PHARMACEUTICAL MARKETING PRACTICES (ECPMP)
As notified by the Government via UCPMP, the term Ethics Committee:
- is the one to be constituted that will look after the activities running and make sure to maintain an ethical standard.
- it will take up the complaints against the entities and take action against such wrong activities for breach of the code.
- the code notified that the committee shall decide the matter within 90 days of the filing of the complaint.
PENALTIES
If there is a breach of the code done by any entity, the committee can propose to suspend and expel the entity from the association, they can also be asked to recover money and items given in the violation of the code.
The ethics committee shall reprimand the entity and publish the full details of the reprimand, the code expressed. Also, the ethics committee shall direct the entity to publish the corrected statements in the same media it published its previous information.
APPEALS
If a party against whom the Ethics Committee has made some decisions, against violation of the code. The party if not satisfied with the decision can approach the Apex Committee for Pharmaceutical Marketing Practice (ACPMP).
The time limit for the appeal is said to be 15 days from the date of receipt of the decision by the Ethics Committee. Additional 15 days can be granted to the appellant if the ACPMP is satisfied that there is sufficient cause for the delay in filing of the appeal.
The ACPMP shall hear the parties and give its decision within 6 months. And the decision given by the Apex Committee will be final and binding on both the parties.
CONCLUSION
This initiative of the Government through Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals is really appreciable and is surely going to bring drastic changes in the pharmaceutical realm. The concern it has shown towards the citizen and the small pharma companies to maintain transparency in drug promotion and making the market competition just and fair.
Uniform Code for Pharmaceutical Marketing Practices 2024 if followed religiously can be a rewarding step. It addresses the need to curb unethical promotional practices that were prevalent in the industry, such as offering gifts and monetary incentives to medical professionals and has directed to form a specific mechanism that will be there to look after if the terms of the code are followed properly.