On December 12, 2014, the Department of Pharmaceuticals (DoP) of the Government of India announced details of the ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’, which would be effective across the country from January 1, 2015.
Just to recapitulate, the DoP came out with a draft UCPMP on March 19, 2012, inviting stakeholders’ comments. Immediately thereafter, the officials at the highest level of the department held several discussions on that draft with the constituents of the pharmaceutical industry, Ministry of Health, Medical Council of India (MCI), besides other stakeholders. Unfortunately, no decision on the subject was taken for nearly three years since then, probably due to intense lobbying by interested constituents.
It is heartening to witness now that the new government, within six months of coming into the office, has ensured that the long awaited UCPMP sees the light of the day. The Dos and Don’ts of the Code for the pharma industry appear to be a replica of the same that the Medical Council of India (MCI) had announced for the doctors, several years ago.
Though UCPMP is not a panacea for all malpractices in the pharma industry, with this announcement, the government at least has sent a clear signal to errant pharma players to shape up, soon. The Government’s action on the subject is also laudable from the good governance perspective, as the codes are quite appropriate to uphold public health interest.
Having acknowledged that unambiguously, I would deliberate in this article why, in my opinion, not much thought has gone to ensure effective implementation of the UCPMP, where subjectivity and vagueness prevail. Moreover, the absence of strong deterrent measures in the document may seriously impede its impact. I shall also briefly touch upon whether self-regulation in pharma marketing practices has worked or not on the ground, globally.
Before I do that, a quick recapitulation of the relevant background, I reckon, would be meaningful.
What necessitated regulation in pharma marketing?
Pro-active role of the pharmaceutical industry in the fight against diseases of all kinds and severity is absolutely critical for any nation.
As happens in most other industries, the ultimate economic performance of a pharma player too predominantly depends on how productive are its sales and marketing activities. In a situation like this, the current ‘free for all model’ of pharma sales and marketing, where end results dominate the means adopted, usually places the profit earning objectives much ahead of public health interest. As result, higher priced medicines are prescribed more, even where their lower price equivalents of similar quality standards are available, besides over or unnecessary prescribing of drugs.
Dubious models are springing up at regular intervals, aiming at achieving all-important objective of generation of more and more prescriptions, which differentiate men from the boys in the pharma marketing warfare.
It is widely alleged that public perceptions are also craftily created on the quality of medicines. All branded generic drugs, including those manufactured by little known companies, are made to perceive better than their cheaper non-branded equivalents, even if coming from better-known and reputed manufacturers. Such industry created perceptions, cleverly channelized through some doctors with vested interests, enhance the drug treatment costs for the patients, significantly.
Other modes of gratifications under different guises also put significant number of doctors in a dilemma between cost effective prescription requirements of the patients and commercial expectations of the pharma players.
To meet with this challenge, the World Health Organization (WHO) in its publication, ‘Pharmaceutical Legislation and Regulation’, clearly articulated that realistic and effective laws and regulations are needed for the pharmaceutical sector, where informal controls are insufficient. This is mainly because of the following two factors:
- Medicines concern the whole population
- The consumer has no way to choose the drug and its price
The new government acts:
Irrespective of whatever had happened in the past, no government with a reasonable agenda of ‘Good Governance’ can afford to ignore the conflict of interests of such kind and magnitude between the doctors and patients.
Hence, comes the importance of uniform codes of pharma marketing practices that can be carefully monitored, thoroughly implementable and measured with transparent yardsticks.
As the World Medical Association states, the key ethical basis for any such code is the understanding that the values of clinical care, of the welfare of society and of science should prevail over commercial imperatives and monetary concerns.
In one of my earlier blog posts of July 07, 2014 titled,“Kickbacks And Bribes Oil Every Part of India’s healthcare Machinery” – A National Shame, I deliberated on similar issues.
Vagueness in measuring delivery of the deliverables:
Let me now get back to the UCPMP. As mentioned in the draft proposal of 2012, after six months from the date of its coming into effect, the government would review the quality of implementation of the UCPMP by the pharma players and their trade associations. If the same is found unsatisfactory, the DoP may consider a statutory code, thereafter.
Interestingly, nothing has been mentioned in the UCPMP document about the process that would be followed by the government to assess the quality of implementation of the Code after six months prompting the DoP to take a very crucial decision, either way.
Vagueness in monitoring UCPMP:
The UCPMP of the DoP states, the Managing Director/CEO of the company is ultimately responsible for ensuring the adherence to the code and the executive head of the company should submit a self-declaration within two months from the date of issue of UCPMP. Thereafter, within two months of the end of every financial year, the declaration needs to be submitted to the respective industry associations for uploading those on the Associations’ websites. These declarations must also be uploaded on the website of the respective companies.
As we know, there are several thousands of pharma marketing players in India. Many of these players, especially those in the micro and small-scale sectors, including their trade associations, do not maintain websites either. Thus, it would be interesting to know how does the DoP monitor such declarations bi-monthly in the six months’ time, to start with.
Lack of strong deterrents and cumbersome process:
There are no strong deterrent measures in the UCPMP to minimize flouting of the code, nor would the complaint filing process encourage any victim with relevant details, such as patients, to lodge a complaint after paying non-refundable Rs.1, 000. It is beyond an iota of doubt that patients are the ultimate victims of most of sales and marketing malpractices by the pharma players.
Moreover, this non-refundable money would ultimately go to whom and how would it be used are still unclear.
Self-regulation in pharma marketing has hardly worked anywhere:
Many international pharmaceutical trade associations, which are primarily the lobbying bodies, are the strong votaries of self-regulations by the industry. They have also created many documents in this regard, which are also displayed in their respective websites.
However, despite all these show pieces, the ground reality is that, the well-hyped self-regulation by the industry to stop the menace of pharma marketing malpractices is not working, anywhere.
As I indicated earlier, the following are a few recent examples of just the last two years to help fathom the enormity of the problem and also to vindicate the point made above:
- In March 2014, the antitrust 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.
- Just before this, in the same month of March 2014, it was reported that a German court had fined 28 million euro (US$ 39 million) to the French pharma major Sanofi and convicted two of its former employees on bribery charges.
- In November 2013, Teva Pharmaceutical reportedly said that an internal investigation turned up suspect practices in countries ranging from Latin America to Russia.
- In 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.
- In 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.
- In 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.
A survey on UCPMP:
A survey report of Ernst and Young titled, “Pharmaceutical marketing: ethical and responsible conduct”, carried out in September 2011 on the UCMP and MCI guidelines, highlighted some of the following points:
- More than 50 percent of the respondents are of the opinion that the UCPMP may lead to manipulation in recording of actual sampling activity.
- Over 50 percent of the respondents indicated that the effectiveness of the code would be very low in the absence of legislative support provided to the UCPMP committee.
- 90 percent of the respondents felt that pharma companies in India should focus on building a robust internal controls system to ensure compliance with the UCPMP.
- 72 percent of the respondents felt that the MCI was not stringently enforcing its medical ethics guidelines.
- Just 36 percent of the respondents felt that the MCI’s guidelines would have an impact on the overall sales of pharma companies.
Disclosure norms necessary:
It is interesting to note that many countries have started acting in this area enforcing various regulatory disclosure norms. Some examples are as follows:
The justice department of the U.S has reportedly wrung huge settlements from many large companies over allegedly unholy nexus between the doctors and the pharmaceutical players.
To address this issue, on February 1, 2013 the Department of Health and Human Services (HHS) of the United States released the final rules of implementation of the ‘Patient Protection and Affordable Care Act (PPACA)’, which is commonly known as the “Physician Payment Sunshine Act” or just the “Sunshine Act”.
This Act has been a part of President Obama’s healthcare reform requiring transparency in direct or indirect financial transactions between the American pharmaceutical industry and the doctors and was passed in 2010 by the US Congress as part of the PPACA.
The Sunshine Act requires public disclosure of all financial transactions and transfers of value between manufacturers of pharmaceutical / biologic products or medical devices and physicians, hospitals and covered recipients. The Act also requires disclosure on research fees and doctors’ investment interests.
These disclosure reports are available on a public database effective September 30th, 2014.
In December 2011, France adopted legislation, which is quite similar to the ‘Sunshine Act’. This Act requires the health product companies like, pharmaceutical, medical device and medical supply manufacturers, among others to mandatorily disclose any contract entered with entities like, health care professionals, hospitals, patient associations, medical students, nonprofit associations, companies with media services or companies providing advice regarding health products.
On January 1, 2012, Netherlands enforced the ‘Code of Conduct on Transparency of Financial Relations’. This requires the pharmaceutical companies to disclose specified payments made to health care professionals or institutions in excess of € 500 in total through a centralized “transparency register” within three months after the end of every calendar year.
Pharmaceutical companies in the UK are planning voluntary disclosures of such payments. One can expect enforcement of such laws in the entire European Union, soon.
Australia and Slovakia:
Similar requirements also exist in Australia and Slovakia.
In Japan, the Japan Pharmaceutical Manufacturers Association (JPMA) reportedly requires their member companies to disclose certain payments to health care professionals and medical institutions on their websites, starting from 2013.
So, why not enforce such disclosure norms in India too?
December 12, 2014 announcement of the UCPMP in its self-regulatory mode sends a message of good intent of the government to curb pharma marketing malpractices in India, which are threats to the society.
However, I reckon, the document is rather weak in its effective implementation potential. Meaningful and transparent deterrent measures to uphold public health interest are also lacking. The entire process also deserves a well-structured monitoring mechanism and digital implementation tools that can be operated with military precision.
It also raises a key question – Is this UCPMP good enough, especially after witnessing that self-regulation in pharma marketing practices is not working in most countries of the world?
In that sense, would the UCPMP, in its current avatar, with weak enforcement potential, shorn of enough deterrent against violations and commensurate sanctions, be able to deliver the requisite deliverables?
By: Tapan J. Ray
Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.