Tag Archives: Malpractices

First ever ‘Code of Pharma Marketing Practices’ by the Government: A strong signal to “Shape Up”!

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After a protracted debate on the alleged ‘unethical marketing practices’ by the pharmaceutical companies, in May 2011, the Department of Pharmaceuticals (DoP) came out with a draft ‘Uniform Code of Pharmaceutical Marketing Practices (UCMP)’ to address this issue squarely and effectively in India.

This decision of the government is the culmination of a series of events, covered widely by the various section of the media, at least, since 2004.

Examples of public/media outcry:

Way back, in its January–March, 2004 issue, ‘Indian Journal of Medical Ethics’ (IJME) in context of marketing practices for ethical pharmaceutical products in India commented: “If the one who decides, does not pay and the one who pays, does not decide and if the one who decides is ‘paid’, will truth stand any chance?” Three year later, in 2007 the situation remained unchanged when IJME (April–June 2007 edition) once again reported: “Misleading information, incentives, unethical trade practices were identified as methods to increase the prescription and sales of drugs. Medical Representatives provide incomplete medical information to influence prescribing practices; they also offer incentives including conference sponsorship. Doctors may also demand incentives, as when doctors’ associations threaten to boycott companies that do not comply with their demands for sponsorship.” Even ‘The Times of India’ reported the following in December 15, 2008: “1. More drugs a doctor prescribes of a specific company, greater are the chances of his/ her winning a car, a high-end fridge or a TV set. 2. Also, drug companies dole out free trips with family to exotic destinations like Turkey or Kenya. 3. In the West, unethical marketing practices attract stiff penalties. 4. In India, there are only vague assurances of self-regulation by the drug industry and reliance on doctors’ ethics”.

Urgent need for change:

In today’s India, the degree of commercialization of the noble healthcare services has reached its nadir, sacrificing the ethics and etiquette both in medical and pharmaceutical marketing practices at the altar of unlimited greed and want.

As a result of fast degradation of ethical standards and most of the noble values  in the healthcare space, the patients in general have started losing faith and trust both on the medical profession and the pharmaceutical industry, by and large. Health related multifaceted compulsions do not allow them, either to avoid such a situation or even raise a strong voice of protest against the vested interests.

Growing discontentment of the patients in both the private and public healthcare space in the country, is being regularly and very rightly highlighted by the media, including reputed medical journals like, ‘The Lancet’ to help arrest this moral and ethical decay with some tangible proactive measures.

MCI took the first step:

In a situation like this, steps taken by the ‘Medical Council of India (MCI)’ in 2009 for the Medical Profession/ Healthcare Practitioners (HCP) deserves kudos from all corners. It is now up to the HCP to properly abide by the new regulations on their professional conduct, etiquette and ethics. The pharmaceutical industry of India should naturally be a party towards conformance of such regulations, in every possible way.

Quite likely, based on the media outcry, the Department of Pharmaceuticals (DoP), also mooted the idea of a self-regulatory UCMP for the entire pharmaceutical industry of India almost around the same time of 2009. However, as was reported, due to lack of consensus within the pharmaceutical industry, the DoP supposedly could not make the said UCMP operational at that time.

A brand new code from the DoP:

Meanwhile in May 2011, the Department of Pharmaceuticals (DoP) released a draft ‘Uniform Code of Marketing Practices’ for the Pharmaceutical Industry of India for comments by the stakeholders. The preamble of the document states as follows:

“This is a voluntary code of Marketing Practices for Indian Pharmaceutical Industry, for the present and its implementation will be reviewed after a period of six months from the date of its coming into force and if it is found that it has not been implemented effectively by the Pharma Associations/Companies, the Government would consider making it a statutory code.”

Some Key features of the DoP Code:

  1. All promotional material must be consistent with the requirements of this Code.
  2. Brand names of products of other companies must not be used for comparison without prior consent of the concerned companies.
  3. Paid or arranged publication of promotional material in journals must not resemble editorial matter.
  4. The names or photographs of healthcare professionals must not be used in promotional material.
  5. Audio-visual material must be accompanied by all appropriate printed material to ensure compliance of the Code.
  6. Samples should be provided directly to prescribing authority and be limited to prescribed dosages for three patients and in response to a signed and dated request from the recipient. Each sample pack shall not be larger than the smallest pack presented in the market.
  7. Medical and Educational events for doctors should be organized in the appropriate venue in India and all expenses must be incurred only for the events held in India.
  8. Outline of a detailed Complaint Lodging and Redressal mechanism (Committee for Code of Pharma Marketing) to ensure compliance of the marketing code.

Overall quality of the DoP marketing code:

  • The overall document is well written, balanced and fair. The DoP should indeed be commended on the great work that they have done in putting all details of pharmaceutical marketing practices together in this document in a very comprehensive manner.
  • This unified Code does not seem to pose any major extra restrictions to the pharmaceutical companies as compared to the MCI guidelines. All concerned should welcome the DoP decision that the same standards will now be applied to all small, mid-sized and large companies, equally. The main focus of the DoP should be in ensuring that all companies across the pharmaceutical industry follow the same standards in their marketing practices and interactions with the HCP.
  • The draft code of the DoP also states that companies must maintain a detailed record of expenditures incurred on these events. It is not quite clear though, as to what extent and detail the pharmaceutical companies are expected to keep these records and how long?  It is also not clear whether these records have to be maintained on file and supplied to the DoP only on specific request for the same or those details are expected to be disclosed on a regular basis to the regulator.
  • The draft indicates that associations must upload full details of received complaints onto their websites. Although this provision could help making the system more transparent, the DoP should clearly articulate the details about the specific information that will require to be disclosed in cases of any proven breach of the code.
  • It is interesting to note in the draft code states that media reports and published letters indicating that a company may have breached the Code will be treated as a complaint.

The global scenario:

Just like in India, a public debate has started since quite some time in the US, as well, on allegedly huge sum of money being paid by the pharmaceutical companies to the physicians on various items including free drug samples, professional advice, speaking in seminars, reimbursement of their traveling and entertainment expenses etc. All these, many believe, are done to adversely influence their rational prescription decisions for the patients.

‘The New England Journal of Medicine’, April 26, 2007 reported that virtually, all doctors in the US take freebies from drug companies, and a third take money for lecturing, and signing patients up for trials. The study conducted on 3167 physicians in six specialties (anesthesiology, cardiology, family practice, general surgery, internal medicine and pediatrics) reported that 94% of the physicians had ‘some type of relationship with the pharmaceutical industry’, and 83% of these relationships involved receiving food at the workplace and 78% receiving free drug samples. 35% of the physicians received re-reimbursement for cost associated with professional meetings or Continuing Medical Education (CME). And the more influential a doctor was, the greater the likelihood that he or she would be benefiting from a drug company’s largess. As a result of strict regulatory measures, the situation in the US has presumably started changing now.

However, such issues are not related only to physicians. ‘Scrip’ dated February 6, 2009 published an article titled: “marketing malpractices: an unnecessary burden to bear”. The article commented: “Marketing practices that seem to be a throwback to a different age continue to haunt the industry. Over the past few months, some truly large sums have been used to resolve allegations in the US of marketing and promotional malpractices by various companies. These were usually involving the promotion of off-label uses for medicines. One can only hope that lessons have been learnt and the industry moves on.” “As the sums involved in settling these cases of marketing malpractices have become progressively larger, and if companies do not become careful even now, such incidents will not only affect their reputation but financial performance too.”

Fierce ongoing debate:

As the financial relationship between the pharmaceutical companies and the physicians are getting increasingly dragged into the public debate, it appears that there is a good possibility of making disclosure of all such payments made to the physicians by the pharmaceutical companies’ mandatory by the Obama administration, as a part of the new US healthcare reform process.

Examples of global voluntary measures:

Eli Lilly, the first pharmaceutical company to announce such disclosure voluntarily around September 2008, has already uploaded its physician payment details on its website. US pharmaceutical major Merck has also followed suit and so are Pfizer and GSK. However, the effective date of their first disclosure details is not yet known.

Meanwhile, Cleveland Clinic and the medical school of the University of Pennsylvania, US are also in the process of disclosing details of payments made by the Pharmaceutical companies to their research personnel and the physicians.

Similarly in the U.K the Royal College of Physicians has reportedly to have called for a ban on gifts to the physicians and support to medical training, by the pharmaceutical companies. Very recently the states like Minnesota, New York and New Jersey in the US disclosed their intent to bring in somewhat MCI like regulations for the practicing physicians of those states.

Transparency: Australia sets an example: The Australian Competition and Consumer Commission (ACCC) has decided to grant authorization for five years to Medicines Australia’s 16th edition of its Code of Conduct. The Code sets standards for the marketing and promotion of prescription pharmaceutical products in Australia. The Code provides, among other measures, a standard to address potential conflicts of interest from unrestricted relationships between pharmaceutical companies and the HCPs, which may harm the consumers through inappropriate prescriptions. The Code also prohibits the pharmaceutical companies from providing entertainment and extravagant hospitality to HCPs with the requirement that all benefits provided by companies should be able to successfully withstand public and professional scrutiny. “The requirement for public disclosure was imposed by the ACCC as a condition of authorization of the previous version of Medicines Australia’s Code and was confirmed on appeal by the Australian Competition Tribunal.” Edition 16 of the Code fully incorporates the public reporting requirements.

Conclusion:

Currently in the US, both in Senate and the House of Congress two draft bills on  ‘The Physician Payment Sunshine Act’ are pending. It appears quite likely that Obama Administration, with the help of this new law, will make the disclosure of payments to physicians by the pharmaceutical companies mandatory.

It appears, India has taken an extra step forward towards this direction as compared to the Obama administration in the USA. The amended MCI regulations for the HCPs coupled with the draft code of the DoP for the entire pharmaceutical industry should make the financial transactional relationship between the physicians and the pharmaceutical industry in India absolutely clean and transparent.

It should be kept in mind by all concerned that the draft code very categorically warns, in case the voluntary code of Marketing Practices is not implemented effectively, the Government would seriously consider making it statutory for the entire pharmaceutical industry of India…quite a strong signal indeed for ‘Shaping Up’!

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.

Are Indian patients victims of “unnecessary tests and procedures, rewards for referrals and irrational use of drugs?” A perspective

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Since quite some time, serious concerns have been expressed by the media, government and the civil society at large about the means adopted by the pharmaceutical industry in general to get their respective brands prescribed by the doctors and why do some of the doctors prescribe what they prescribe to the patients out of multiple available choices.
The MCI Guidelines:
Being concerned mainly by the media outcry, the Medical Council of India (MCI), a year ago, amended their related guidelines for the doctor, clearly articulating what they can and cannot do during their interaction and transaction with the pharmaceutical and related industries.
The Ministry of Health believes that these guidelines, if strictly enforced, would severely limit what the doctors can receive from the pharmaceutical companies in terms of free gifts of wide ranging financial values, entertainments, free visits to exotic locations under various commercial reasons, lavish lunch and dinner etc. in exchange of prescribing specific brands of the concerned companies more…more…and more.
“The Lancet” report:
Let me now combine this scenario with a recent report on India dated January 11, 2011, published in ‘The Lancet’, which states in a similar, though not the same context, as follows:
1. “Reported problems (which patients face while getting treated at a private doctor’s clinic) include unnecessary tests and procedures, rewards for referrals, lack of quality standards and irrational use of injection and drugs. Since no national regulations exist for provider standards and treatment protocols for healthcare, over diagnosis, over treatment and maltreatment are common.”
2. “Most people accessed private providers for outpatient care – 78% in rural areas and 81% in urban areas.”
3. “India’s private expenditure of nearly 80% of total expenditure on health was much higher than that in China, Sri Lanka and Thailand.”
Considering the above three critical issues of India, as reported by ‘The Lancet’, the need to follow a transparent code of pharmaceutical marketing practices by the entire pharmaceutical industry is of utmost importance. Recently amended MCI guidelines for the doctors are welcome steps in the right direction.
Are patients just the pawns?
In the absence of all these, the patients of all socio-economic strata will continue to be exploited as pawns by some unscrupulous healthcare players to satisfy their raw greed for making fast bucks at the cost of the intense agony of the ailing patients and their near and dear ones.
As stated earlier, this phenomenon is not new at all. Over a period of time, many stakeholders of the pharmaceutical industry and the public at large have been raising the issue of physicians being influenced in their prescription decisions by various types of payments made to them by the pharmaceutical companies. Such types of significant and seemingly avoidable expenditures, presumed to be considered by the respective companies as a part of their ‘marketing costs’, are believed to be included in the maximum retail price (MRP) of medicines, making them more expensive to the patients.
On the other hand, most physicians believe that free entertainment, gifts, their travel costs and seminar sponsorships in no way influence their prescription decision for the patients.
This is not a just India specific issue. Some skeptics believe that it has now become an all pervasive global scandal.
Self-regulation by the industry is most desirable:
To address this issue effectively, some national and international pharmaceutical associations have come out with their own codes of ethical marketing practices along with appropriate stakeholder grievance redressal mechanism, effectively.
Despite all these, it is an undeniable fact that overall perceptual image of the pharmaceutical industry in this respect to the stakeholders, in general, is not as good as it should have been.
The Government intervened in India:
Being alarmed by various media reports on the alleged pharmaceutical marketing (mal) practices in the country, the Department of Pharmaceutical (DoP) had advised the pharmaceutical industry to develop an ‘Uniform Code of Marketing Practices (UCMP)’, which will be applicable to the entire pharmaceutical industry in India.
It has been reported that the said UCMP with its stakeholder grievance redressal mechanism in a transparent procedural format, was submitted to the government by the major pharmaceutical industry associations in India. However, because of dissent of some section of the industry, the UCMP has not received the ‘green signal’ of the government, as yet. It was expected that all stakeholders will help maintaining the sanctity of the UCMP to address this sensitive global and local issue, effectively.
An emerging trend of public disclosure:
Around third quarter of 2008, in an industry first step, Eli Lilly announced its intent of full disclosure of payments that the company made to the physicians for various commercial reasons. Eli Lilly indicated disclosure of payments of more than US $500 to the physicians for advice and speaking at the seminars. Over a period of time, the company indicated that it will expand such disclosure to include other forms of payments to the physicians like gifts, various entertainment and travel.
Eli Lilly was soon followed in this direction by global pharmaceutical majors like, Merck and GlaxoSmithKline (GSK).
However, in India, such instances have not been reported, as yet.
Skepticism with voluntary disclosure:
Some are still skeptical about announcements of such ‘voluntary disclosure of payment to the physicians’ by the global pharmaceutical majors to bring in better transparency in the functioning of the industry.

This section of people believes, there are hundreds and thousands of other pharmaceutical companies, who will not follow such precedence of voluntary disclosure in the absence of any properly enforced regulation.
Conclusion:
In all the countries and India is no exception, pharmaceutical companies, by and large, try to follow the legal ways and means to maximize turnover of their respective brands. Many follow transparent and admirable stringent self-regulations, stipulated either by themselves or by their industry associations.
‘Self-regulation with pharmaceutical marketing practices’ and ‘voluntary disclosure of payment to the physicians’ by some leading global pharmaceutical companies are laudable steps to address this vexing issue. However, the moot question still remains, are all these good enough for the entire industry?
It is about time that all players in the healthcare space realize, in case these voluntary measures of the industry and the guidelines of the regulators like MCI, do not work effectively for any reason, there will be no other option but for the government to step in with iron hand and ‘fool proof’ regulations.
The popular dictum, especially, used in the healthcare industry, “all these are for the patients’ interest” should not be allowed to be misused or abused, any further, by some unscrupulous elements and greedy profiteers, to squeeze out even the last drop of financial resource from the long exploited population of ailing patients of India.

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.

MCI has been dissolved but the guidelines to doctors must remain, carefully sanitizing the ambiguities within the process

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The recent developments within the MCI are indeed very disturbing and were definitely avoidable, if appropriate checks and balances were in place within the system. Even after the immediate ‘damage control measures’ by the Government, I reckon, the stigma on the credibility of MCI, may continue to haunt the institution, for a reasonably long time. The steps taken by the government, so far, are definitely necessary.

The new board appointed by the Ministry of Health, we expect, will work out an appropriate policy framework not only to restore the credibility of MCI, but also to put in place enough measures to prevent repetition of blatant misuse of power by the vested interests, in future.

The other side of it:

In today’s India, blatant commercialization of the noble healthcare services has reached its nadir, as it were, sacrificing the ethics and etiquettes both in medical and pharmaceutical marketing practices at the altar of unlimited greed. As a result of fast degradation of ethical standards and most of the noble values supposed to be deeply rooted in the healthcare space, the patients in general are losing faith and trust both on the medical profession and the pharmaceutical industry, by and large. Health related multifaceted compulsions do not allow them, either to avoid such a situation or even raise a strong voice of protest.

Growing discontentment – a stark reality:

Growing discontentment of the patients in the critical area of both private and public healthcare in the country, is being regularly and very rightly highlighted by the media to encourage or rather pressurize all concerned to arrest this moral and ethical decay and reverse the evil trend, without further delay, with some tangible regulatory measures.

It was a laudable move by the MCI, the current fiasco not withstanding:

In such a prevailing situation, recent steps taken by the ‘Medical Council of India (MCI)’ deserves kudos from all corners. It is now up to the medical profession to properly abide by the new regulations on their professional conduct, etiquette and ethics. The pharmaceutical industry of India should also be a party towards conformance of such regulations, may be albeit indirectly.

No room for ambiguity:

The amended MCI regulations, no doubt, are aimed at improving the ethical standards in the medical profession and are expected to achieve the desired objectives. However, in many places the guidelines lack absolute clarity.

Ambiguity, if any, in the MCI regulations, should be addressed through appropriate amendments, in case such action is considered necessary by the experts group and the Ministry of Health. Till then all concerned must ensure its strict compliance… for patients’ sake. The amended MCI regulations are only for the doctors and their professional bodies. Thus it is up to the practicing doctors to religiously follow these regulations without forgetting the ‘Hippocrates oath’ that they had taken while accepting their professional degree to serve the ailing patients.

If these regulations are implemented properly, the medical profession, I reckon, could win back their past glory and the trust of the patients, as their will be much lesser possibility for the patients to get financially squeezed by some unscrupulous elements in this predominantly noble profession.

A concern:

Although the new MCI regulations are steps in the right direction, the pharmaceutical industry, by and large, does have an apprehension that very important and informative ‘continuing medical education (CME)’, which in turn could help the patients immensely, may get adversely impacted with this new regulation; so are the areas involving medical/clinical research and trials.

What is happening in the global pharmaceutical industry?

Just like in India, a public debate has started since quite some time in the US, as well, on allegedly huge sum of money being paid by the pharmaceutical companies to the physicians on various items including free drug samples, professional advice, speaking in seminars, reimbursement of their traveling and entertainment expenses etc. All these, many believe, are done to adversely influence their rational prescription decisions for the patients.

USA:

In the USA ‘The Pharmaceutical Research and Manufacturers of America (PhRMA)’ has recently revised their code of marketing practices as follows:

• “Prohibits distribution of non-educational items (such as pens, mugs and other “reminder” objects typically adorned with a company or product logo) to healthcare providers and their staff. The Code acknowledges that such items, even though of minimal value, “may foster misperceptions that company interactions with healthcare professionals are not based on informing them about medical and scientific issues.”

• Prohibits company sales representatives from providing restaurant meals to healthcare professionals, but allows them to provide occasional meals in healthcare professionals’ offices in conjunction with informational presentations. The Code also reaffirms and strengthens previous statements that companies should not provide any entertainment or recreational benefits to healthcare professionals.

• Includes new provisions that require companies to ensure that their representatives are sufficiently trained about applicable laws, regulations and industry codes of practice – including this Code – that govern interactions with healthcare professionals. Companies are also asked to assess their representatives periodically and to take appropriate action if they fail to comply with relevant standards of conduct.

• Provides that each company will state its intentions to abide by the Code and that company CEOs and Compliance Officers will certify each year that they have processes in place to comply, a process patterned after the concept of Sarbanes-Oxley compliance mechanisms. Companies also are encouraged to get external verification periodically that they have processes in place to foster compliance with the Code. PhRMA will post on its Web site a list of all companies that announce their pledge to follow the Code, contact information for company compliance officers, and information about the companies’ annual certifications of compliance.

• Other additions to the Code include more detailed standards regarding the independence of continuing medical education (CME); principles on the responsible use of non-patient identified prescriber data; and additional guidance for speaking and consulting arrangements with healthcare professionals, including disclosure requirements for healthcare providers who are members of committees that set formularies or develop clinical practice guidelines and who also serve as speakers or consultants for a pharmaceutical company.

• Other changes to the Code include, PhRMA’s recent acceptance of the revised Physician Payments Sunshine Act in the Senate.”

Raging ongoing debate on the financial relationship between industry and the medical profession:

As the financial relationship between the pharmaceutical companies and the physicians are getting increasingly dragged into the public debate, it appears that there is a good possibility of making disclosure of all such payments made to the physicians by the pharmaceutical companies’, like the proposed Physician Payments Sunshine Act in the USA, mandatory in many other countries, probably even in India.

Exemplary voluntary measures taken by large global pharmaceutical majors:

Eli Lilly, the first pharmaceutical company to announce such disclosure voluntarily around September 2008, has already uploaded its physician payment details on its website. US pharmaceutical major Merck has also followed suit and so are Pfizer and GSK. However, the effective date of their first disclosure details is not yet known.

Meanwhile, Cleveland Clinic and the medical school of the University of Pennsylvania, US are also in the process of disclosing details of payments made by the Pharmaceutical companies to their research personnel and the physicians. Similarly in the U.K the Royal College of Physicians has been recently reported to have called for a ban on gifts to the physicians and support to medical training, by the pharmaceutical companies. Very recently the states like Minnesota, New York and New Jersey in the US disclosed their intent to bring in somewhat MCI like regulations for the practicing physicians of those states.

Transparency is the key for drug industry relationships – Australia sets another example:

The Australian Competition and Consumer Commission (ACCC) has decided to grant authorization for five years to Medicines Australia’s 16th edition of its Code of Conduct. The Code sets standards for the marketing and promotion of prescription pharmaceutical products in Australia.

The Code provides, among other things, a standard to address potential conflicts of interest from unrestricted relationships between pharmaceutical companies and healthcare professionals, which may harm consumers, for example through inappropriate prescribing by healthcare professionals.

The Code prohibits pharmaceutical companies from providing entertainment and extravagant hospitality to healthcare professionals, with the requirement that all benefits provided by companies successfully withstand public and professional scrutiny.

“The requirement for public disclosure was imposed by the ACCC as a condition of authorization of the previous version of Medicines Australia’s Code and was confirmed on appeal by the Australian Competition Tribunal.” Edition 16 of the Code fully incorporates the public reporting requirements.

Conclusion:

Currently in the US, both in Senate and the House of Congress two draft bills on ‘The Physician Payment Sunshine Act’ are pending. It appears quite likely that Obama Administration, with the help of this new law, will make the disclosure of payments to physicians by the pharmaceutical companies mandatory.

If President Obama’s administration takes such regulatory steps, will India prefer to remain much behind? The new amended MCI regulations together with such disclosure by the pharmaceutical companies, if and when it comes, could make the financial transactional relationship between the physicians and the pharmaceutical industry squeaky clean and totally transparent.

By Tapan 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.

To restore patients’ confidence MCI has amended its regulations… to strengthen it further will the government consider an Indian version of ‘Physician Payment Sunshine Act’?

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In today’s India, blatant commercialization of the noble healthcare services has reached its nadir, as it were, sacrificing the ethics and etiquettes both in medical and pharmaceutical marketing practices at the altar of unlimited greed. As a result of fast degradation of ethical standards and most of the noble values supposed to be deeply rooted in the healthcare space, the patients in general are losing faith and trust both on the medical profession and the pharmaceutical industry, by and large. Health related multifaceted compulsions do not allow them, either to avoid such a situation or even raise a strong voice of protest.

Growing discontentment – a stark reality:

Growing discontentment of the patients in the critical area of both private and public healthcare in the country, is being regularly and very rightly highlighted by the media to encourage or rather pressurize all concerned to arrest this moral and ethical decay and reverse the evil trend, without further delay, with some tangible regulatory measures.

A laudable move by the MCI:

In such a situation, recent steps taken by the ‘Medical Council of India (MCI)’ deserves kudos from all corners. It is now up to the medical profession to properly abide by the new regulations on their professional conduct, etiquette and ethics. The pharmaceutical industry of India should also be a party towards conformance of such regulations, may be albeit indirectly.

No room for ambiguity:

Ambiguity, if any, in the MCI regulations, which has been recently announced in the official gazette, may be addressed through appropriate amendments, in case such action is considered necessary by the experts group and the Ministry of Health. Till then all concerned must ensure its strict compliance… for patients’ sake. The amended MCI regulations are only for the doctors and their professional bodies. Thus it is up to the practicing doctors to religiously follow these regulations without forgetting the ‘Hippocrates oath’ that they had taken while accepting their professional degree to serve the ailing patients. If these regulations are implemented properly, the medical profession, I reckon, could win back their past glory and the trust of the patients, as their will be much lesser possibility for the patients to get financially squeezed by some unscrupulous elements in this predominantly noble profession.

What is happening in the global pharmaceutical industry?

Just like in India, a public debate has started since quite some time in the US, as well, on allegedly huge sum of money being paid by the pharmaceutical companies to the physicians on various items including free drug samples, professional advice, speaking in seminars, reimbursement of their traveling and entertainment expenses etc. All these, many believe, are done to adversely influence their rational prescription decisions for the patients.

Raging ongoing debate on the financial relationship between industry and the medical profession:

As the financial relationship between the pharmaceutical companies and the physicians are getting increasingly dragged into the public debate, it appears that there is a good possibility of making disclosure of all such payments made to the physicians by the pharmaceutical companies’ mandatory by the Obama administration, as a part of the new US healthcare reform process.

Exemplary voluntary measures taken by large global pharmaceutical majors:

Eli Lilly, the first pharmaceutical company to announce such disclosure voluntarily around September 2008, has already uploaded its physician payment details on its website. US pharmaceutical major Merck has also followed suit and so are Pfizer and GSK. However, the effective date of their first disclosure details is not yet known. Meanwhile, Cleveland Clinic and the medical school of the University of Pennsylvania, US are also in the process of disclosing details of payments made by the Pharmaceutical companies to their research personnel and the physicians. Similarly in the U.K the Royal College of Physicians has been recently reported to have called for a ban on gifts to the physicians and support to medical training, by the pharmaceutical companies. Very recently the states like Minnesota, New York and New Jersey in the US disclosed their intent to bring in somewhat MCI like regulations for the practicing physicians of those states.

Conclusion:

Currently in the US, both in Senate and the House of Congress two draft bills on ‘The Physician Payment Sunshine Act’ are pending. It appears quite likely that Obama Administration, with the help of this new law, will make the disclosure of payments to physicians by the pharmaceutical companies mandatory. If President Obama’s administration takes such regulatory steps, will India prefer to remain much behind? The new MCI regulations together with such disclosure by the pharmaceutical companies, if and when it comes, could make the financial transactional relationship between the physicians and the pharmaceutical industry squeaky clean and totally transparent.

By Tapan 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.

Amendment of ‘Professional Conduct, Etiquette and Ethics’ Regulations for the Doctors by the MCI could dramatically change the Pharmaceutical Marketing Practices in India, hereafter.

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As reported in the media, the notification of the Medical Council of India (MCI) dated December 10, 2009 amending the “Indian Medical Council (Professional Conduct, Etiquette and Ethics), Regulations 2002″ has been welcomed by the medical profession.
Areas of stricter regulations:

The notification specifies stricter regulations for doctors in the following areas, in their relationship with the ‘pharmaceutical and allied health sector industry’:

1. Gifts
2. Travel facilities
3. Hospitality
4. Cash or Monetary grants
5. Medical Research
6. Maintaining Professional Autonomy
7. Affiliation
8. Endorsement

These guidelines have come into force with effect from December 14, 2009.

Possible implications:

With this new and amended regulation, the MCI has almost imposed a ban on the doctors from receiving gifts of any kind, in addition to hospitality and travel facilities from the pharmaceutical and allied health sector industries in India.

Moreover, for all research projects funded by the pharmaceutical industry and undertaken by the medical profession, prior approval from the appropriate authorities for the same will be essential, in addition to the ethics committee.

Although maintaining a cordial and professional relationship between the pharmaceutical industry and the doctors is very important, such relationship now should no way compromise the professional autonomy of the medical profession and a medical institution, directly or indirectly.

It also appears that the common practices of participating in private, routine and more of brand marketing oriented clinical trials could possibly be jettisoned as a pharmaceutical strategy input.

The new MCI regulations is much stricter:

Since the new amended regulations of the MCI are much stricter than the existing codes of marketing practices of the pharmaceutical industry associations, there could be an emerging disconnect between these two practices till such time a clearer picture emerges after due deliberations by all concerned, in this matter.

It is also interesting to note, how would the pre December 14, 2009 commitments for the post December 14, 2009 period, of both the medical profession and the industry related to such regulated practices, be handled by the MCI, in future.

Conclusion:

Be that as it may, the new ball game of pharmaceutical marketing strategies and practices will no longer be driven by more of a ‘deep pocket’ syndrome and less of ‘cerebral power’, by all concerned.

If this happens, I shall not be surprised to witness a dramatic change in the prescription share of various companies in the next 3 to 5 years thereby impacting the ranking of these companies in the Indian pharmaceutical industry league table.

Thus, the name of the game in the pharmaceutical marketing space, in not too distant future, will be “generation and effective implementation of innovative ideas”.

By Tapan 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.

For greater transparency in the relationship between physicians and the pharmaceutical companies, does India need an Act like, proposed ‘The Physician Payment Sunshine Act’ of the USA?

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As we discussed earlier, to make the pharmaceutical companies disclose and report various types of payments made to the physicians, two Senators of the United States of America, Chuck Grassley and Herb Kohl introduced a bill called ‘The Physician Payment Sunshine Act’ in January, 2009.If this bill is passed in 2010, the government will make available to the public by 2011 all types of payments made to the physicians by the pharmaceutical companies over a cumulative value of US $ 100.Items of disclosure:

Among various other heads, the following items related to the “payment made to the physicians’’ will require to be reported:

• Consulting Fees

• Compensation for services other than consulting

• Honoraria

• Gifts

• Entertainment

• Food

• Travel

• Education

• Research

• Charitable Contributions

• Royalties or licenses

• Current or prospective ownership or investment interests

• Compensation for serving as a faculty member or as a speaker for a continuing medical education program

• Grant

• Reporting will be required for compensation towards serving as faculty, or as a speaker for a CME program, and grants.

• Any other nature of the payment or other transfer of value as defined by the government

Research payments:

Pharmaceutical companies will also require reporting aggregate amounts of research payments in a specified manner.

Items exempt from disclosure:

There will be items, as mentioned below, which will be exempted from such reporting:

• Product samples

• Payments in the aggregate of less than $100

• The loan of a device for less than 90 days

• Patient education materials

• Warranty replacements (devices)

• Items for use as a patient

• Discounts and rebates

• In-kind items used in charity care

• Dividends from a publicly-traded company

Penalties for default from disclosure:

Proposed penalties have been categorized as follows:

• For unintentional failure to report: fines from US $1,000 – US $10,000 for each payment not reported with a cap of US $150,000/year

• For intentional failure to report: fines from US $10,000 – US $100,000 for each payment not reported with a cap of US $1 million/year.

World Medical Association (WMA) Statement Concerning the Relationship Between Physicians and Commercial Enterprises:

Meanwhile, WMA is also trying to address this vexing issue and coming closer to some sort of voluntary disclosure at their end, as well.

Such type of statement was first adopted by the WMA in its General Assembly at Tokyo, Japan in October 2004. Recently in its General Assembly held at New Delhi in October 2009, the statement was further amended coming closer to the disclosure of payments.
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The preamble of the amended statement articulates the following:

“In the treatment of their patients, physicians use drugs, instruments, diagnostic tools, equipment and materials developed and produced by commercial enterprises. Industry possesses resources to finance expensive research and development programmes, for which the knowledge and experience of physicians are essential. Moreover, industry support enables the furtherance of medical research, scientific conferences and continuing medical education that can be of benefit to patients and the entire health care system. The combination of financial resources and product knowledge contributed by industry and the medical knowledge possessed by physicians enables the development of new diagnostic procedures, drugs, therapies, and treatments and can lead to great advances in medicine.

However, conflicts of interest between commercial enterprises and physicians occur that can affect the care of patients and the reputation of the medical profession. The duty of the physician is to objectively evaluate what is best for the patient, while commercial enterprises are expected to bring profit to owners by selling their own products and competing for customers. Commercial considerations can affect the physician’s objectivity, especially if the physician is in any way dependent on the enterprise.

Rather than forbidding any relationships between physicians and industry, it is preferable to establish guidelines for such relationships. These guidelines must incorporate the key principles of disclosure, avoidance of obvious conflicts of interest and the physician’s clinical autonomy to act in the best interests of patients.
These guidelines should serve as the basis for the review of existing guidelines and the development of any future guidelines.”

This new statement of the WMA, having a remarkable similarity with the ‘Codes of marketing Practices’ of the pharmaceutical industry associations in India, like Organization of pharmaceutical Producers of India (OPPI) and Indian Drug Manufacturers’ Association (IDMA) is indeed a welcome step in the right direction.

Conclusion:

Along with the self regulation initiatives by both the industry and WMA, this bill, if passed, will surely and significantly improve the transparency related to the transaction between the pharmaceutical companies and the physicians to the public at large in the US to start with. However, bringing research within the ambit of this bill could possibly be a contentious issue.

Be that as it may, in India a large section of the civil society still feels that it is now high time for the Government of India to decide whether the nation needs an Act like the proposed ‘Physician Payment Sunshine Act’ of the US to bring in greater transparency in the process of various financial transactions between the pharmaceutical industry in India and the physicians, along with the continuing initiatives of self-regulations by both the industry and the physicians.

By Tapan 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.

Will mandatory disclosure of ‘payments to physicians’ by the pharmaceutical companies be an overall part of “Healthcare reform process” in the US and what about India?

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The brief Scenario in India:
In India over 20, 000 pharmaceutical companies of varying size and scale of operations are currently operating. It is alleged that lack of regulatory scrutiny is prompting many of these companies to adapt to ‘free-for-all’ types of aggressive sales promotion and cut-throat marketing warfare involving significant ‘wasteful’ expenditures. Such practices involve almost all types of their customer groups, excepting perhaps the ultimate consumer, the patients.

Unfortunately in India there is no single regulatory agency, which is accountable to take care of the healthcare needs of the patients and their well being.

The pharmaceutical industry of India, in general, has expressed the need to self-regulate itself effectively, in the absence of any regulatory compulsion. However, many activists groups and NGOs feel that the bottom-line in this scenario is the demonstrable transparency by the pharmaceutical companies in their dealings with various customer groups, especially the physicians.

The brief scenario in the US:

Like in India, a public debate has started since quite some time in the US, as well, on allegedly huge sum of money being paid by the pharmaceutical companies to the physicians on various items including free drug samples, professional advice, speaking in seminars, reimbursement of their traveling and entertainment expenses etc. All these, many believe, are done to adversely influence their rational prescription decisions for the patients.

As the financial relationship between the pharmaceutical companies and the physicians are getting increasingly dragged into a raging public debate, it appears that there is a good possibility of making disclosure of all such payments made to the physicians by the pharmaceutical companies mandatory by the Obama administration, as a part of the new US healthcare reform process.

As I said in my earlier article, Eli Lilly, the first pharmaceutical company to announce such disclosure voluntarily around September 2008 has already uploaded its physician payment details on its website.

US pharma major Merck has also followed suit and so are Pfizer and GSK. However, the effective date of their first disclosure details is not yet known.

In the meantime, Cleveland Clinic and the medical school of the University of Pennsylvania, US are in the process of disclosing details of payments made by the Pharmaceutical companies to their research personnel and the physicians. Similarly in the U.K the Royal College of Physicians has been recently reported to have called for a ban on gifts to the physicians and support to medical training, by the pharmaceutical companies.

Conclusion:

Currently in the US, both in Senate and the House of Congress two draft bills on ‘The Physician Payment Sunshine Act’ are pending. It appears quite likely that Obama Administration, with the help of this new law, will make the disclosure of payments to physicians by the pharmaceutical companies mandatory, along with its much discussed new healthcare reform process.

If President Obama’s administration takes such regulatory steps will Dr. Manmohan Singh government prefer to stay much behind?

I shall try to explore that emerging scenario in my next blog post.

By Tapan 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.

Allegation of ‘Marketing Malpractices’ in the pharmaceutical Industry of India has assumed a huge proportion– who will ‘bell the cat’?

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Sometime back, in its January – March, 2004 issue, ‘Indian Journal of Medical Ethics’ (IJME)in context of marketing practices for ethical pharmaceutical products in India commented:“If the one who decides, does not pay and the one who pays, does not decide and if the one who decides is ‘paid’, will truth stand any chance?”Three year after, in 2007 the situation remained unchanged when IJME (April – June 2007 edition) once again reported:

“Misleading information, incentives, unethical trade practices were identified as methods to increase the prescription and sales of drugs. Medical Representatives provide incomplete medical information to influence prescribing practices; they also offer incentives including conference sponsorship. Doctors may also demand incentives, as when doctors’ associations threaten to boycott companies that do not comply with their demands for sponsorship.”

This situation is not limited to India alone. It has been reported from across the world. ‘The New England Journal of Medicine’, April 26, 2007 reported that virtually, all doctors in the US take freebies from drug companies, and a third take money for lecturing, and signing patients up for trials. The study conducted on 3167 physicians in six specialities (anaesthesiology, cardiology, family practice, general surgery, internal medicine and paediatrics) reported that 94% of the physicians had ‘some type of relationship with the pharmaceutical industry’, and 83% of these relationships involved receiving food at the workplace and 78% receiving free drug samples. 35% of the physicians received re-imbursement for cost associated with professional meetings or continuing medical education (CME). And the more influential a doctor was, the greater the likelihood that he or she would be benefiting from a drug company’s largess.

Even our own ‘The Times of India’ reported the following on December 15, 2008:

1. “The more drugs a doctor prescribes of a company, greater the chances of him or her winning a
car, a high-end fridge or TV set.”

2. “Also, drug companies dole out free trips with family to exotic destinations like Turkey or Kenya.”

3. “In the West, unethical marketing practices attract stiff penalties.”

4. “In India, there are only vague assurances of self-regulation by the drug industry and reliance on
doctors’ ethics.”

Such issues are not related only to physicians. ‘Scrip’ dated February 6, 2009 published an article titled: “marketing malpractices: an unnecessary burden to bear”. The article commented:

“Marketing practices that seem to be a throwback to a different age continue to haunt the industry. Over the past few months, some truly large sums have been used to resolve allegations in the US of marketing and promotional malpractice by various companies. These were usually involving the promotion of off-label uses for medicines. One can only hope that lessons have been learnt and the industry moves on.”

“As the sums involved in settling these cases of marketing malpractices have become progressively larger, and if companies do not become careful even now, such incidents will not only affect their reputation but financial performance too.”

Huge settlement sums involved in such ‘federal misdemeanour’ cases could act as a reasonably strong deterrent in the USA. However, in India, even the written complaints to the Drug Controller General of India (DCGI) about ‘off label’ promotion of drugs attracts no such punitive measure. Marketing malpractices in India seems to have now become a routine, as it were. All stakeholders, in principle, agree that it should stop. But in absence of any strong deterrent, like in the USA, will it remain just as another wishful thinking?

Both the Government and the industry talk about ‘self regulation’ to address this issue. This is indeed a very pragmatic thought. A part of the industry already has such a self regulation system in place. But the moot question that comes in everybody’s mind is it working, effectively?

To effectively address this issue should the entire pharmaceutical industry in India together not form a self regulatory body in line with “Consumer complaint council” of “The Advertising Standards Council of India”, as was created by the Fast Moving Consumer Goods (FMCG) industry? The decisions taken by the ‘pharma council’ against each complaint of marketing malpractice should be disseminated to all concerned, to make the system robust and transparent…and in that process it will act as a strong deterrent too.

By Tapan 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.