Uniform Code of Pharmaceuticals Marketing Practices (UCPMP) – Code for Writing Promotional Material

The Department of Pharmaceuticals (DoP), Government of India, released Uniform Code of Pharmaceuticals Marketing Practices (UCPMP) on 1st January 2015.
UCPMP is a voluntary code that should be adopted by pharmaceutical industry to curb unethical practices in the healthcare sector. UCPMP bears significance as pharmaceutical companies have been accused of massive enticements to secure prescriptions from the medical fraternity for a very long time.

UCPMP for promotional materials:

• All promotional material issued by a product authorization holder or with his authority, must be consistent with the requirements of this Code.
• Where the purpose of promotional material is to provide persons qualified to prescribe or supply with sufficient information upon which to reach a decision for prescribing or for use, then the following minimum information, must be given clearly and legibly and must be an integral part of the advertisement:
  • The relevant product authorization number and the name and address of the holder of the authorization or the business name and address of the part of the business responsible for placing the medicinal product on the market
  • The name of the product, and a list of the active ingredients, using the common name, placed immediately adjacent to the most prominent display of the name of the product
  • Recommended dosage, method of use and, where not obvious, method of administration
  • Adverse reactions, warnings and precautions for use, and relevant contraindications of the product
  • A statement that additional information is available on request
  • The date on which the above particulars were generated or last updated
• 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 promotional material in journals, such promotional material must not resemble editorial matter.
• Promotional material must conform, both in text and illustration, to canons of good taste and must be expressed so as to recognize the professional standing of the recipients and not be likely to cause any offence.
• The names or photographs of healthcare professionals must not be used in promotional material.
• Promotional material must not imitate the devices, copy, slogans, or general layout adopted by other companies in a way that is likely to mislead or confuse.
• Where appropriate (for example, in technical and other informative material), the date of printing or of the last review of promotional material must be stated.
• Extremes of format, size, or cost of promotional material must be avoided.
• 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 accompanied by all appropriate printed material so that all relevant requirements of the Code are complied with.

Other key highlights of UCPMP are:

• No gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to persons qualified to prescribe or supply drugs, by a pharmaceutical company or any of its agents i.e. distributors, wholesalers, retailers, etc.
• Free samples of drugs shall not be supplied to any person who is not qualified to prescribe such products
• Companies or their associations/representatives or any person acting on their behalf shall not extend any travel facility inside the country or outside, including rail, air, ship, cruise tickets, paid vacations, etc., to healthcare professionals and their family members for vacation or for attending conference, seminars, workshops, etc. as a delegate
• Companies should not pay any cash or monetary grants to any healthcare professionals for individual purpose in individual capacity under any pretext
• Funding for medical research, study etc., can only be extended through approved institutions by modalities laid down by law/rules/guidelines adopted by such approved institutions, in a transparent manner

Need for UCPMP – Self-regulation in pharma marketing has hardly worked anywhere

Many international pharmaceutical trade associations, which are primarily the lobbying bodies, strongly advocate self-regulations (such as following UCPMP) by the industry. They have also created many documents in this regard, which are also displayed in their respective websites. However, despite all this, the ground reality is that, the well-hyped self-regulation by the industry to stop the menace of pharma marketing malpractices is not working; few recent examples are cited below:

• March 2014 – the anti-trust regulator of Italy reportedly fined two Swiss drug majors, Novartis and Roche 182.5 million euros (U$ 251 million) for allegedly blocking distribution of Roche’s Avastin cancer drug in favor of a more expensive drug Lucentis that the two companies market jointly for an eye disorder.
• March 2014 -A German court fined 28 million euro (US$ 39 million) to the French pharma major Sanofi and convicted two of its former employees on bribery charges.
• May 2013 – Sanofi was reportedly fined US$ 52.8 Million by the French competition regulator for trying to limit sales of generic versions of the company’s Plavix.
• August 2012 – Pfizer Inc. was reportedly fined US$ 60.2 million by the US Securities and Exchange Commission to settle a federal investigation on alleged bribing of overseas doctors and other health officials to prescribe medicines.
• April 2012 – a judge in Arkansas, US, reportedly fined Johnson & Johnson and a subsidiary more than US$1.2 billion after a jury found that the companies had minimized or concealed the dangers associated with an antipsychotic drug.

As per the recent information available, the government is planning to make the UCPMP practices mandatory, which have so far been voluntary. The DoP is working on to finalize the mandatory code practices. The move has been triggered by insufficient compliance to the existing voluntary code by pharmaceutical companies. The mandatory codes will also involve legal implications and invoking of marketing licenses.

Turacoz healthcare solutions fully believe in following ethical codes such UCPMP. Our medical writing team is well versed with these codes and tries to adapt to the same while providing promotional material content to our client.