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Patients’ Trust And Pharma Remain Strange Bedfellows?

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Like many other industries, pharmaceutical companies too often talk about improving focus on effective ‘stakeholder-relationship management’. The doctors obviously form an integral part of this process. There is nothing wrong with it. Nevertheless, serious concern of ‘conflict of interest’ between the two entities is being raised on the means adopted to achieve the targeted end results.

Much as the drug makers expect that these methods are easily justifiable and would not bother anyone, it usually doesn’t happen that way, especially among the informed patients. When patient-interest gets compromised in this complex transactional web, the residual impact is awfully negative. Over a period of time, such episodes lead to a patient-doctor trust-gap, having a snowballing effect on the integral constituent of this saga – the pharma industry.

In this article, I shall briefly explore the scale and depth of such trust-gap and try to fathom who can effectively address this cancerous spread. This initiative when implemented well, won’t just protect patients’ health interest, ensuring affordable health care of good quality for all. It will also help rejuvenate pharma players’ declining reputation, facilitating long-term business interest –unchained by too many stifling regulations.  

For being in the paradise of health care…

‘Trust’ is the bedrock of any meaningful relationship and is usually built based on one’s experience, perception and feelings, besides a few other factors. It falls apart in the presence of deception or lies, even if these are well camouflaged. Similarly, clandestine acts when unearthed could also lead to the same outcome. The charted pathways for development or collapse of patients’ trust regarding doctors, or government policy makers trust towards pharma players are fundamentally no different.

In a scenario where patients can trust doctors for suggesting the best affordable treatment of good quality, including safe and effective drugs; hospitals and caregivers are just and conscientious; insurance companies are caring and fair in their dealings; drug prices are rational; published clinical trial reports on drug efficacy and safety are unbiased, the communication from pharma companies are trustworthy without any hidden agenda – we are living in the paradise of health care.

Nonetheless, the same paradise built on patients’ valuable trust would get shattered, as the drug regulators and the media get to know and unearth lies and clandestine dealings between doctors and pharma companies. Patients soon realize, though the hard way that they are being short-changed. A trust-gap is created, giving rise to an avoidable vicious cycle in the healthcare space. It is difficult to break, as one witness today, but not impossible, either.

The trust-gap is all pervasive:

Although, we are discussing here the trust-gap between doctors and drug companies on the one hand, and patients, drug policy makers and the regulators on the other – the trust-gap is all pervasive. This is vindicated by a startling headline of the January 16, 2018 edition of a leading Indian business daily. It says: “Over 92% people don’t trust the health care system in India: Study”.

It quotes the GOQii India Fit 2018 report saying a large part of which includes doctors, hospitals, pharma, insurance companies and diagnostic labs. The following table shows the ranking of some these constituents in terms of trust gap of Indians.

Rank Healthcare system People don’t trust (%)
1. Hospitals 74
2. Pharma companies 62.8
3. Insurance companies 62.8
4. Medical clinics 52.6
5. Doctors 50.6
6. Diagnostic Labs 46.1

The survey emphasizes that a series of failure, particularly the negligence of hospitals in the recent past has made it hard to trust in the system. The lack of transparency was the other reason that stands out.

Not a recent phenomenon, but increasing:

A trust-deficit in the healthcare system isn’t a recent phenomenon. This was corroborated in the article, titled ‘Doctors, patients, and the drug industry: Partners, friends, or foes?’ It was published almost a decade ago – in the February 07, 2009 edition (Volume 338) of the British Medical Journal (BMJ). The authors quoted a contemporary report issued by the ‘Royal College of Physicians’, which captured an all-time low relationship between the drug industry, academia, healthcare professionals, and patients, even at that time. The paper suggested that it is in the interests of all parties to bridge the trust-gap, without further delay.

As mentioned before, this particular discussion will focus on just two areas – pharma companies and the doctors – not all constituents of the health care system. This is primarily to have a congruity with my previous discussion on the importance of ‘perception’ in pharma. From that perspective, it is evident from the BMJ paper that a trust-gap exists not just in the doctor-patient relationship, but also between the drug policy makers and the pharma industry. I shall try to drive home this point with the following two examples.

 A. The trust-gap in doctor-patient relationships for ‘Conflict of Interests’:

The article titled, “Conflict of Interest in Medicine” featuring in the JAMA Network on May 02, 2017 described ‘Conflict of Interest’ as ‘a situation in which a person is or appears to be at risk of acting in a biased way because of personal interests.’

The article further elaborated thatdoctors’ relationships with drug companies (including any payments or gifts received from the companies) might affect how they report the results of research studies, what they teach medical students about particular drugs, or what treatments they recommend for patients. Moreover, doctors may preferentially refer patients to those diagnostic facilities for tests that may financially benefit them for doing so.

B. The trust gap between the government policy makers and the pharma industry:

That such trust-deficit is all pervasive, gets reverberated even through the speeches of no less than the Prime Minister of India.

On April 18, 2018, during an interactive session of theBharat Ki Baat, Sabka Saath‘ diaspora event at the Central Hall in Westminster, UK, Prime Minister Modi,reportedly said that doctors visit Singapore and Dubai to attend conferences, and not because someone is sick. “The pharma companies invite them for that. To finally break the resultant sale of expensive medicines, the government has launched generic stores where medicines of similar quality are sold at cheaper prices” – the PM further added during his interaction with the audience present in this function at London.

As expected, the medical community in India expressed displeasure over the remark of the PM on doctors and pharma companies on a foreign soil, the same media report highlighted.

Interestingly, just a year ago, on April 17, 2017, while inaugurating a hospital in Surat, a home to several top Indian generic drug makers Prime Minister Modi had said: “We are going to make legal arrangements to ensure that when doctors write prescriptions they write that generic medicines are sufficient and that there is no need for any other medicine.”

Some ineffective interventions:

As I said before, this downward spiral with a widening trust-gap in the healthcare space of the country needs to be arrested soon, with effective steps. The best remedial measure in such cases will obviously be self-regulation by all concerned, keeping patients’ interest at the center.

As an antidote to this problem, in the previous Government regime, ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’ was put in place, but only for voluntary implementation by the drug companies.

Enough time has elapsed in experimenting with this process, since then. Regrettably, like many other countries, self-regulation in this area to address the malady of trust deficit hasn’t worked in India too. Both the ‘Professional Conduct and Ethics’ of Medical Council of India (MCI) for doctors, and the UCPMP of the Department of Pharmaceuticals (DoP) for drug companies intended to address the so-called doctor-pharma industry unholy nexus, have not yielded expected results. The saga continues, unabated.

Conclusion:

From the patient-interest perspective, what is happening today in the global healthcare space is indeed baffling. Improving access to good quality, affordable drugs for all, has become a challenge in many countries, just as in India. Consequently, alleged unholy doctor-industry nexus that contributes a significant part to this problem, is attracting greater public attention today. The issue is being often raised even at the highest echelon of the incumbent government. But, more puzzling is, even after the PM’s public anguish, the DoP doesn’t seem to have walked the talk. Much hyped – the proposed mandatory UCPMP has not yet seen the light of the day, despite a clear indication of the same.

The question then arises, what happens if it does not happen due to political or any other compulsions? In that case, I reckon, the primary initiative to bridge the existing trust-gap, should rest on pharma companies. They may not always agree with all public allegations leveled against them, as the creator of this ungodly collaboration, and rightly so. Nonetheless, remaining in a perpetual denial mode in this regard, won’t help the pharma industry, anymore. More so, when the number of net-savvy, reasonably well-informed and globally connected patient groups, are fast increasing. Besides being fair in all business transactions, drug players need to sincerely engage with patients, not in usual condescending ways, but with due respect, for mutual benefits.

Otherwise, despite pharma industry and patients being interdependent in so many ways, sans a strict regulatory framework with legal teeth, ‘patients’ trust’ and ‘pharma’ will continue to remain uneasy, if not strange bedfellows.

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.

Public Healthcare Space: Evaluating Three Fresh Edicts

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Medicines constitute a significant cost component of modern healthcare systems across the world. However, in India the situation is even worse, where as per recent studies, drugs contribute as high as around 70 percent of the total treatment cost. This is mainly because overall healthcare system in the country is fundamentally different not just from the developed world, but also from many other developing countries like, China, Brazil, South Africa and Thailand, to name a few.

In most of those countries significant expenses towards healthcare including medicines are reimbursed either by the Governments or through health insurance or similar mechanisms. However, the Indian situation is just the reverse, where around 72 percent of overall healthcare costs, including medicines, are private or Out of Pocket (OoP), incurred by the individuals/families.

According to a recent report, ‘about 38 million people in India (which is more than Canada’s population) fall below the poverty line every year due to healthcare expenses, of which 70% is on purchase of drugs’, as stated above.

In this context, it is worth noting that for patented drugs, the Drug Policy of December 2012 clearly articulates that Government of India will follow the approach of price negotiation with the respective companies. Unfortunately, work done in this so important area by the concerned authority, so far, has been rather superficial, if not shoddy. Most of the patented products, which are prohibitively expensive, continue to remain out of reach of a vast majority of patients in india.

Expenditure towards healthcare – a fundamental need:

Expenditure towards healthcare in India, which is largely private, highly exploitative and thus expensive, is absolutely essential for all, either to be able to earn a living for a family or for maintaining a reasonable quality of life.

According to an ‘Access Survey’ conducted by IMS Consulting Group in 2012, ‘Out Patient (OP)’ treatment costs in private care is ~2-3 times that of public and in case of ‘In-Patient (IP)’ care it is ~4-8 times the cost of Public care.

Focus has not been just enough:

Since 1970, the Government of India and various States have been adopting  measures including, National Health Mission (NHM), Rashtriya Swasthya Bima Yojana (RSBY), Drug Price Control Order (DPCO), besides others, to make healthcare in general and medicines in particular affordable and accessible to the common man. However, these measures though essential, have not delivered quite well when measured against the set objectives. This keeps on happening, due to lack of accountability and inefficient Government control over the processes involved together with fast increasing exploitative mindset in the private healthcare space, over the last several decades.

Health being a State subject inequity in access:

Health being a State subject in India, there has been large variations in public healthcare spend within various States of the country. Some of the poorer States have low  per capita public healthcare expenditure and some of the richer states incur significantly more, leading to huge inequity of access, especially among the poorer sections of the society. (Source: IMS Consulting 2012)

Three fresh edicts:

In the above backdrop, the decision of the Government of India to increase the National Health Expenditure Budget from 1.2% to 2.5% of GDP in the 12th Five Year Plan of India in 2012 has the potential to be a game changer in the public healthcare space of India.

It is envisaged that this decent increase in the budgetary allocation will help initiating the process of Universal Health Care (UHC) to ensure free access to essential health services for every citizen of the country, including cashless in-patient and out-patient treatment for primary, secondary and tertiary care.

Probably as a precursor to UHC, the Government of India has announced three fresh edicts:

1. Budgetary clearance for ‘Free distribution of essential medicines’ by the States

2. Notification for operationalizing the new ‘Central Medical Services Society (CMSS)’ to streamline the drug procurement system 

3. Announcement for implementation of ‘Standard Treatment Guidelines (STGs)’ 

The above edicts are indeed laudatory, as these measures, if taken effectively in tandem would also help maximizing overall productivity of the public healthcare delivery systems, immensely.  This is expected mainly because, the process would require avoidance of unnecessary medicines and diagnostics tests, chain of multiple doctor visits starting from GPs, specialists to super specialists, besides simultaneous re-engineering of below par public healthcare delivery systems of the country.

1. Budgetary clearance for free distribution of essential medicines by the States:

Late 2012, the Union Government made its first major move by formally clearing Rs. 13,000 Crore  (around US$ 2.2 billion) towards providing free medicines for all through government hospitals and health centers. The State Governments under National Health Mission to utilize this fund for purchase and free distribution of essential medicines. Some State Governments are already in the process of implementing this scheme, though effective implementation of the same, across the country, still remains a challenge.

This new scheme, I reckon, has also the potential to hasten the overall growth of the pharmaceutical industry, as poor patients who could not afford will now have access to essential medicines. On the other hand, rapidly growing middle class population will continue to favor branded generic drugs prescribed by the doctors at the private hospitals and clinics.

Some people are apprehending that generic drug makers will have brighter days as the project starts rolling on. This apprehension is based on the assumption that large branded generic players will be unable to take part in this big ticket drug procurement process of the Government, which seems to be imaginary at this stage.

However, in my view, it could well be a win-win situation for all types of players in the industry, where both the generic-generic and branded-generic businesses could continue to grow simultaneously.

That said procedural delays and drug quality issues, while procuring cheaper generics, might pose to be a great challenge for the Government to ensure speedier implementation of this project. Drug regulatory and law enforcing authorities will require to be extremely vigilant to ensure that while sourcing cheaper generic drugs, “Public health and safety” due to quality issues do not get compromised in any way.

POTENTIALITY: Significant increase in access to medicines and simultaneous sharp reduction on OoP expenses.

2. Operationalization of CMSS for drug procurement:

Recently this year, the Union Health Ministry issuing the final notification reportedly has made the drug procurement system through Central Medical Services Society (CMSS) formally operational.

The drug procurement for different flagship program, of the Government like National Health Mission, will now be done through the CMSS.

The notification says:

  • The CMSS will be responsible for procuring health sector goods in a transparent and cost-effective manner and distributing them to the States/UTs by setting up an IT enabled supply chain infrastructure including warehouses in 50 locations.
  • The main objective of CMSS is to ensure uninterrupted supply of health-sector goods to the state Government, which will then maintain the flow to the govt. health facilities such as district hospitals, primary health centers and community health centers.
  • All decisions on procurement will be taken by the CMSS without any reference to the Ministry of Health and Family Welfare.
  • The Ministry will be responsible only for policy decisions concerning procurement and for monitoring its performance.
  • The CMSS will also assist the state governments to set up similar organizations in states to reform their procurement.
  • The Government has appointed the Director General and other key persons to run the organization, which will look to eliminate deficiencies in the existing system of purchasing medicines, vaccines, contraceptives and medical equipment for all government’s flagship program.
  • At present, the ministry procures drugs departmentally and through agents, drawing flaks and raking controversies at regular intervals.

This seemingly transparent drug procurement process for public use, would prompt tough price negotiations with the manufacturers for purchase of medicines leading to significant reduction in drug prices, as evidenced already in the States like, Tamil Nadu and Rajasthan.

POTENTIALITY: Significant reduction in public healthcare costs, especially for medicines.

3. Announcement for implementation of Standard Treatment Guidelines (STGs):

Another recent news that Standard Treatment Guidelines (STGs) for 20 disciplines will soon be put in place in India is indeed a breath of fresh air. The centers of excellence for healthcare, both public and private, for around 1.2 billion population of the country, are still rather limited.

STG is usually defined as a systematically developed statement designed to assist practitioners and patients in making decisions about appropriate cost-effective treatment for specific disease areas.

For each disease area, the treatment should include “the name, dosage form, strength, average dose (pediatric and adult), number of doses per day, and number of days of treatment. STG also includes specific referral criteria from a lower to a higher level of the diagnostic and treatment requirements.

For an emerging economy, like India, formulation of STGs would ensure cost-effective healthcare benefits to a vast majority of its population.

STGs, therefore, will provide:

- Standardized guidance to practitioners

- Cost-effective ‘health outcomes’ based services

The Ministry of Health is now reportedly mulling to streamline in a phased manner the disease treatment procedures and protocols by introducing STGs in 20 disciplines under the ‘Clinical Establishments Act’ of the country. These disciplines are Cardiovascular, Endocrinology, ENT, Gastroenterology, General Surgery, Interventional Radiology, Laboratory Medicine, Obstetrics and Gynecology, Organ Transplant, Pediatrics, Oncology, Urology, Nephrology, GI Surgery, Medicine Respiratory, Medicine Non-Respiratory, Critical Care, Ophthalmology, Neurology and Orthopedics.

The National Council for Clinical Establishments (NCCE) is the apex body under the Clinical Establishments Act. STGs, therefore, will be binding on all hospitals and establishments registered under the Clinical Establishments Act 2010.

The Council has already deliberated on the draft STGs prepared by the experts in the respective disciplines of medicines. Surgical intervention in cardiovascular diseases reportedly will assume priority while implementing the STGs.

It is expected that the first of the STGs will be announced soon.

Currently only Uttar Pradesh, Mizoram, Sikkim, Rajasthan, Arunachal Pradesh, Himachal Pradesh and Jharkhand, apart from all Union Territories, have adopted the Act. Again, health being a State subject in India, all the States of the country will need to enforce this Act to make the initiative successful. However, states like West Bengal have their own Clinical Establishment Act, while Tamil Nadu has its own STGs.

Incidentally, putting STGs in place has been one of the long-standing demands of many, including the medical insurance companies. This is mainly because, laid-down protocols will make the hospitals avoiding unnecessary procedures on insured patients, thereby reducing the cost of treatment significantly.

POTENTIALITY: Huge reduction in healthcare cost, avoiding wastage in every step of any disease treatment. This could also help the medical insurance companies containing hospitalization costs, hopefully leading to reduced insurance premium.

Conclusions: 



All these three edicts of the Government, do promise a huge potential to help containing the overall cost of treatment in general and the costs of medicines in particular.

Effective implementation of these important initiatives would call for a significant change in mindset of all concerned. Doctors, hopefully, would also avoid using those expensive drugs having no significant improvement in ‘health outcomes’ over the cheaper alternatives.

STGs would initially need to be encouraged not just through self-regulation of the medical profession, but by the pharmaceutical industry and other allied interested parties in this area, as well. If ‘self-regulation’ does not work, stringent regulatory measures must be enforced by the Government to protect patients’ health interest.

No doubt both the Union and the State Governments of India would still have lot to chew in pursuit of ensuring affordable healthcare in general and medicines in particular, to all.

That said, would expectations of crafty implementation of these edicts, at least, flicker a ray of hope in an otherwise gloomy and exploitative overall healthcare environment of the country?

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 asks Doctors to Prescribe Medicines in Generic Names

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Last week, on January 21, 2013, in a circular addressed to the Dean/Principals of all the Medical Colleges, Director of all the hospitals and Presidents of all the State Medical Councils, the Medical Council of India (MCI) called upon the doctors practicing medicine to prescribe Drugs with Generic names, as far as possible.

The MCI circular reinforced that all Registered Medical Practitioners under the Indian  Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 will comply with it without fail. At the same time, wide publicity of this regulation be given and necessary steps be taken to ensure observance of this provision in its letter and spirit.

PSC also recommended it:

Prior to this circular, Parliamentary Standing Committee (PSC) for Health and Family Welfare in its recommendation to the ‘Rajya Sabha’ of the Indian Parliament on August 4, 2010, also recommended prescription of medicines by their generic names.

The basic premises:

All these recommendations are reportedly based on the basic premises that high ‘Sales and Marketing’ costs of branded generic drugs in India can be significantly reduced, if prescription in generic names are encouraged, to make medicines available to patients at cheaper and much affordable prices.

‘Sales and Marketing’ expenses of ‘Branded’ drugs:

According to a recent report in BMJ every dollar that the pharmaceutical companies spend on “basic research,” US$ 19 goes toward promotion and marketing.

Another recent report from Forbes India titled “Will Pharma Companies Have to Stop ‘Gifting’ Doctors?“ states as follows:

“The budget that pharma companies have for freebies is huge. According to one estimate, the top 20 drug makers in India spend about $600 million a year on only freebies for doctors. It is still a paltry sum compared to the US, where drug makers spend $58 billion or more annually on marketing drugs, including freebies for doctors.

While the practice of giving gifts to doctors is rampant internationally, several sources told Forbes India that in India it borders on petty corruption. Doctors often refuse to write prescriptions unless they are offered at least Rs 50,000 in cash every time a new drug needs to be prescribed.” 

The prescribers’ ‘diplomatic’ stand:

It is interesting to note that some doctors reportedly are of the view that:

“For the benefit of patients and to get the best possible results, highest quality drugs with best possible pharmacological properties should be used by all doctors. If the quality of generic drugs is up to high standards, doctors should prescribe generic medicines.”

This comment needs to be taken considering that it has been made in response to the above MCI circular by a doctor. However, I reckon, in the real world such intent, as reflected in various independent retail audit reports, is hardly seen getting translated into reality, at least not just yet.

Ongoing debate on the quality issue with generic medicines:

Many opine that there could be a huge quality issue with generic medicines, which could make such drugs unsafe for the patients.

In response, other school of thought leaders often raise, among many others, the following questions:

  1. Are all generic medicines of dubious quality and branded generics are of good quality?
  2. If quality parameters can be doubted for both in many cases, why then raise this issue only in context of generic medicines?
  3. If the quality issues are not much with the larger companies and are restricted to only smaller companies, why then some branded generic drugs of smaller companies prescribed so much by the doctors?
  4. Currently many large companies market the same drugs both as generics and also as branded generics, why then the branded generic versions sell more than their generic equivalents, though manufactured by the same large companies?
  5. Why are the generic medicines available at ‘Jan Aushadhi’ outlets (though small in number) cost a fraction of their branded generic equivalents?
  6. Why do the doctors also not show much interest in prescribing generic medicines as of date?
  7. Why not those who argue that phonetically similar or wrong reading of generic names at the chemist outlets may cause health safety hazard to the patients, also realize that many already existing phonetically similar brand names in totally different therapy areas may cause similar hazards too?
  8. How does a doctor while prescribing a branded generic or generic medicine decide which ones are of good quality and which others are not?

A recent study:

As reported by the US FDA, ‘A recent study evaluated the results of 38 published clinical trials that compared cardiovascular generic drugs to their brand-name counterparts. There was no evidence that brand-name heart drugs worked any better than generic heart drugs. [Kesselheim et al. Clinical equivalence of generic and brand name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA.  2008; 300(21) 2514-2526]‘.

Similar studies are also required in India to resolve much hyped ‘quality issue’ for generic medicines.

Some countries are taking similar steps: 

Just to cite an example, as reported by ‘The Guardian” on August 23, 2011, the Spanish government enacted a law compelling the doctors of Spain to prescribe generic drugs rather than more expensive patented and branded pharmaceuticals, wherever available. This move is expected to help the Spanish government to save €2.4 billion (£2.1billion) a year, as in Spain the drugs are partly reimbursed by the government.

As a result, the doctors in Spain will now have to prescribe only in the generic or chemical names of the respective drugs. Consequently the pharmacies will be obliged to dispense ‘the cheapest available versions of drugs, which will frequently mean not the better-known brand names sold by the big drugs firms’.

Interestingly, the above point, though considered as a positive fall-out in Spain, is reportedly taken negatively in India with the oft repeated argument, ‘India is different’.

Prescriptions for generic medicines were a record high in America in 2010:

As per published reports, last year i.e. in 2010, generic medicines accounted for more than 78 percent of the total prescriptions dispensed by retail chemists and long-term care facilities in the US. This is a record high and is four percentage points more than what it was in 2009 and came up from 63% as recorded in 2006.

This vindicates that prescription in generic names is encouraged in the US too for various reasons.

Concerns over pharmaceutical marketing malpractices in India:  

Ethical concerns on significant expenditure towards alleged sales and marketing malpractices since quite some time has further strengthened the demand for prescriptions only in the generic name of a drug.

Frequent reports by Indian media have already triggered a raging debate in the country on the subject, involving even the Government and also the Parliament. It has been reported that a related case is now pending with the Supreme Court for hearing in not too distant future.

In 2010, “The Parliamentary Standing Committee on Health’ expressed its deep concern that ‘the evil practice’ of inducement of doctors continued because the Medical Council of India (MCI) has no jurisdiction over the pharma industry and it could not enforce the code of ethics on it.”

It was widely reported that the letter of a Member of Parliament, Dr. Jyoti Mirdha to the Prime Minister Dr. Manmohan Singh, attaching a bunch of photocopies of the air tickets claiming, “Doctors and their families were beating the scorching Indian summer with a trip to England and Scotland, courtesy a pharmaceutical company”, compelled the Prime Minister’s Office (PMO) to initiate inquiry and action on the subject.

The letter had claimed that as many as 30 family members of 11 doctors from all over India enjoyed the hospitality of the said pharmaceutical company.

In addition Dr. Mirdha reportedly wrote to the PMO stating, “The malpractice did not come to an end because while medical profession (recipients of incentives) is subjected to a mandatory code, there is no corresponding obligation on the part of the healthcare industry (givers of incentives). Result: Ingenious methods have been found to flout the code.”

The report also indicated that the Department of Pharmaceuticals (DoP) is trying to involve the Department of Revenue under the Ministry of Finance to explore the possibilities in devising methods to link the money trail to offending companies and deny the tax incentives.

Incidences of such alleged malpractices related to financial relationship between the pharmaceutical companies and the medical profession are unfolding reasonably faster now. All these issues are getting increasingly dragged into the public debate where government can no longer play the role of a mere bystander.

Taking the first step closer to that direction, Central Board of Direct Taxes (CBDT), which is a part of Department of Revenue in the Ministry of Finance, has now decided to disallow expenses on all ‘freebies’ to Doctors by the Pharmaceutical Companies in India.

A circular dated August 1, 2012 of the CBDT that the any expenses incurred by the pharmaceutical companies on gifts and other ‘freebies’ given to the doctors will no longer be allowed as business expenses. 

The response in favor of ‘Branded Generics’:

The proponents of ‘Branded Generics’ argue that the brand name is built on various differential value parameters to create a proper position of the brand in the minds of healthcare professionals as well as the patients. Thus, brand names offer a specific identity to generic drugs and is of high importance for both the doctors and the patients. 

The areas of complexity:

Those who favor branded generics also highlight, among others, the following three areas of complexity:

1. In India, over 50% medicines prescribed by the physicians are for Fixed Dose Combinations (FDCs), spanning across almost all therapeutic categories. Thus, it could be difficult for doctors to prescribe such medicines in generic names and might equally be difficult for the chemists to dispense such prescriptions.

They also argue that in case of any mistake of dispensing the wrong drug by the chemist inadvertently, the patients could face serious consequences.

2. Currently doctors use brand names to differentiate one formulation from the others. Different brands of even single ingredient medicines may have inherent differences in their formulations like, in the drug delivery systems (controlled/sustained release), kind of coatings allowing dissolution in different parts of alimentary canal, dispersible or non-dispersible tablets, chewable or non-chewable tablets etc. Since doctors are best aware of their patients’ conditions, they may wish to prescribe a specific type of formulation based on specific conditions of the patients, which may not be possible by prescribing only in generic names.

3. Patients also could face other difficulties due to generic prescribing. As is known, different brands of FDCs may have different proportions of same active ingredients. If chemists do not know or have the exact combination prescribed by the doctor in their shops, they would possibly substitute with a different combination of same drugs, which could well be less effective or even harmful to the patients.

The common perception:

The entire issue arises out of the key factor that the patients do not have any say on the use/purchase of a brand/brands that a doctor will prescribe.

It is generally believed by many that doctors predominantly prescribe mostly those brands, which are promoted to them by the pharmaceutical companies in various questionable ways, as reported above.

Thus, in today’s world and particularly in India, the degree of commercialization of the noble healthcare services, as often reported by the media, has reached a new high, sacrificing the ethics and etiquette both in the medical and also in the pharmaceutical sales and marketing practices at the altar of greed and conspicuous consumption.

Conclusion:

The recent MCI circular to doctors calling upon them to prescribe medicines in the generic names making them more affordable to patients, may be an important step towards a better future.

This assumes even greater importance when medicines constitute over 70 percent of the total treatment cost, especially for domiciliary treatment, and around 80 percent of total healthcare expenses is ‘out of pocket’ in our country.

However, the moot point is, the need of the hour calls for a total change in the mindset of all concerned. The importance of genuine care for the societal needs, while being in pursuit of professional excellence, in tandem, should ideally be demonstrated through voluntary measures by the concerned players in this area, leaving enforcement of stringent regulations as a last resort by the Government.

That said, while generic drugs per se are in no way bad for the patients, a careful analysis of all possible risk factors against expected benefits, especially for FDCs and different drug delivery formulations, will be important in the Indian perspective. Without effectively addressing the above issues, if prescriptions in generic names are made mandatory for all drugs, it could possibly be counter productive jeopardizing patients’ safety and interest.

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. 

 

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.