What President Obama And Prime Minister Modi Discussed On IPR And Healthcare In India

During the recent visit of the US President Barack Obama to India from January 25-27, 2015, both the domestic and international media was abuzz with the speculation, whether or not India would concede some ground to America on the prevailing, generally considered, well balanced patent regime in India.

Many expected that the American delegation would succeed in getting some specific assurances from Prime Minister Narendra Modi to follow the line of the US style Intellectual Property Rights (IPR) in India, which would help the American pharma companies to maximize their financial returns in the country.

The assurances from India were expected mainly in areas involving grant of patents even to those pharma products, that do not quality for the same under section 3(d) of the Indian Patents Act 2005, dilution of provisions for Compulsory License (CL) and creation of a new provision for Data Exclusivity in the country, besides a few others.

As everyone noticed, just before the US President’s visit, interested groups both in India and also from abroad intensified lobbying and released op-eds to create pressure on the Indian negotiators, in general, and the Prime Minister Modi in particular.

Terming the Indian Patents Act weak, the lobby groups turned the Indian IPR regime on its head. Playing the role of India’s benefactor, they re-packaged their shrill collective voice into pontificating words while giving interviews to the Indian media by saying: “A strong IPR regime could allow the country (India) to make a major contribution to tackling health challenges, both domestically and around the world.”

Additional US interest in Indian IP regime from TPP perspective:

Exemplary demonstration of India’s resistance to intense external pressure, time and again, for dilution of the IP regime in the country, seems to have become a model to follow for the emerging economies of the world, in general. This trend now gets reflected even among some of the members of the 12-nation Trans-Pacific Partnership (TPP), which is a proposed regional regulatory and investment treaty.

According to reports, TPP members, such as, Brunei, Malaysia, Singapore and Vietnam are negotiating hard to get incorporated somewhat similar to Indian IP rules in the TPP agreement. Besides America, other members of the TPP are Australia, Japan and New Zealand, Canada, Chile, Mexico and Peru.

TPP negotiations are generally expected to follow the overall framework of American laws. However, according to media reports, based on the leaked draft of the TPP, the data exclusivity period for biologic medicines has already been negotiated down to 7 years, from 12 years under the US Affordable Care Act.

However, on January 27, 2015, US Senator Orrin Hatch, Chairman of the Senate Finance Committee reportedly said that he would oppose Senate approval of the TPP, if it does not provide 12 years of patent protection for biologics.

The same day, at a hearing before the House Ways and Means Committee, US Trade Representative Mike Froman reportedly reiterated, “The US is insisting on 12 years of IP protections, even though the Obama administration’s budget calls for 7-year exclusivity on biologic meds.”

It is also worth noting that Nobel laureate Joseph E. Stiglitz in an op-ed titled, “Don’t Trade Away Our Health”, published in The New York Times of January 30, 2015 commented as follows:

“TPP could block cheaper generic drugs from the market. Big Pharma’s profits would rise, at the expense of the health of patients and the budgets of consumers and governments.”

Clicking on this short video clip you will be able watch another similar viewpoint on TPP, its general perspective and what it encompasses.

Thus, the closely guarded ‘turf war’ on TPP is now heating up, making negotiations increasingly tougher to arrive at a consensus on the IP rules that would be applicable to pharmaceutical products in this trade initiative. Consequently, the evolving scenario has prompted the interested groups to keenly follow, with hopes, the outcome of Presidents Obama’s recent visit to India, especially in the pharma IP areas. This is because, many emerging economies of the world are now appreciative of the prevailing well-balanced patent regime in India.

After the 12-nation TPP agreement comes into force, probably following the lines of the US IP laws, it is quite possible that India may sometime in future would prefer to be a part of this agreement for greater trade facilitation, as the country comes closer to America…Who knows?

However, in that case the bottomline is, India would have to amend relevant provisions of its Patents Act in conformance with the requirements of mainly the US pharmaceutical companies and the IP laws prevailing in America, as this will be necessary to become a new member of this treaty.

Discussion in the summit meeting:

According to the Joint Statement on the summit meeting released by the White House, President Obama and Prime Minister Modi discussed the following subjects related to IPR and Healthcare in India, as detailed below:

  • Reaffirmed the importance of providing transparent and predictable policy environments for fostering innovation.  Both countries reiterated their interest in sharing information and best practices on IPR issues, and reaffirmed their commitment to stakeholders’ consultations on policy matters concerning intellectual property protection.
  • Reaffirmed their commitment to the Global Health Security Agenda (GHSA) and announced specific actions at home and abroad to prevent the spread of infectious diseases, including a CDC-Ministry of Health Ebola and GHSA preparedness training, expansion of the India Epidemic Intelligence Service, and development of a roadmap to achieve the objectives of the GHSA within three years.
  • Committed to multi-sectoral actions countering the emergence and spread of antimicrobial resistance (AMR), and cooperation in training of health workers in preparedness for infectious disease threats. The Leaders agreed to focus science and technology partnerships on countering antibiotic resistant bacteria and promoting the availability, efficacy and quality of therapeutics.
  • Welcomed further progress in promoting bilateral cooperation on cancer research, prevention, control, and management and agreed to continue to strengthen the engagement between the CDC and India’s National Centre for Disease Control.
  • Welcomed the upcoming completion of an Environmental Health, Occupational Health and Injury Prevention and Control MoU between the U.S. Centers for Disease Control and Prevention and the Indian Council for Medical Research to further collaborative efforts to improve the health and welfare of both countries’ citizens.
  • Agreed to expand the India-U.S. Health Initiative into a Healthcare Dialogue with relevant stakeholders to further strengthen bilateral collaboration in health sectors including through capacity building initiatives and by exploring new areas, including affordable healthcare, cost saving mechanisms, distribution barriers, patent quality, health services information technology, and complementary and traditional medicine.
  • Pledged to encourage dialogue between the U.S. Department of Health and Human Services and its Indian counterparts on traditional medicine.
  • Pledged to strengthen collaboration, dialogue, and cooperation between the regulatory authorities of the two countries to ensure safety, efficacy, and quality of pharmaceuticals, including generic medicines.
  • Agreed to accelerate joint leadership of the global Call to Action to end preventable deaths among mothers and children through a third meeting of the 24 participating countries in India in June 2015.  As host, India will showcase the power of new partnerships, innovations and systems to more effectively deliver life-saving interventions.
  • Also lauded the highly successful collaboration on a locally produced vaccine against rotavirus, which will save the lives of an estimated 80,000 children each year in India alone, and pledged to strengthen the cooperation in health research and capacity building through a new phase of the India-U.S. Vaccine Action Program.

As stated earlier, during this summit meeting, US lobbyists were reportedly nurturing a hope that Prime Minister Modi would eventually agree, at least in principle, to jettison section 3(d) on the patentability criteria enshrined in the Indian Patents Act 2005 and significantly water down the country’s Compulsory License (CL) provisions. This expectation increased, when the US President made the investment promise of U$4 billion in India.

That said, from the above points of discussion in the joint statement, it appears that no breakthrough on the part of the US was achieved especially in the IPR space, during the summit.

However, in other areas of bilateral healthcare co-operation, such as, science and technology partnerships in countering antibiotic resistant bacteria; cancer research and traditional medicines; the reaffirmations made by the two leaders are encouraging.

US pressure on IP to continue:

Going by India’s reaffirmation during the summit meeting of its commitment to consultations with America on policy matters related to IPR protection and US Trade Representative Mike Froman’s reported affirmation of the following to the US lawmakers during a Congressional hearing held on January 27, 2015, it is construed by the IP activists that the kettle has possibly started boiling:

- “We have been concerned about the deterioration of the innovation environment in India, and we have engaged with the new government since they came into office in May of last year about our concerns,”

- “We held the first Trade Policy Forum in four years in November. I just returned from India yesterday as a matter of fact … and in all of these areas, we have laid out a work program with the government of India to address these and other outstanding issues.”

- “We are in the process of providing comments on that draft policy proposal on IPR, and we are committed to continuing to engage with them to underscore areas of work that needs to be done in copyright, in trade secrets as well as in the area of patents,”

- “We’ve got a good dialogue going now with the new government on this issue, and we’re committed to working to achieve concrete progress in this area,”

Media reports also indicate that US pressure on IPR would continue, as they highlight:

“Threatened by free trade of high-quality and affordable medicines, US-based pharmaceutical companies and politicians friendly with the industry are using prominently placed op-eds, large advertisements on Washington, D.C. buses, and letters to President Obama to spread false information -claiming India’s rules are not legal or discourage innovation. The companies have been threatening to withhold investment if India does not adopt weaker patent laws that would extend pharmaceutical monopolies and stymie the country’s generic industry.”

I discussed some of these issues in my blog post of January 19, 2015, titled “New National IPR Policy of India – A Pharma Perspective”.

Conclusion:

Irrespective of whatever the US-India Joint Statement says on IPR, some experts do apprehend that Indian Government may now wilt under continuous intense pressure from the American Government. This is mainly because, India’s Commerce and Industry’s Minister has reportedly sought America’s inputs in the finalization process of the new National IPR policy of the country.

On this score, let me hasten to add that it may not be prudent to read too much into it, as seeking stakeholders’ comments on such matter is a practice that India has been following since long on various issues and policies.

However, at the same time, other groups of experts nurture a quite different viewpoint. They are confident that the nationalist Modi Government, under no circumstances would concede its long nurtured strategic ground on IPR to the US power play.

Emerging countries across the globe are keenly watching this intense game of  ‘Power Chess’, as they plan to emulate India in many of the pharmaceutical IP areas to uphold the public health interest, providing affordable healthcare to all.

These are still early days. Thus, in my view, on January 25, 2015, what President Barack Obama and Prime Minister Narendra Modi discussed on the IPR regime in India may not be as important as what they would eventually decide to agree, disagree or agree to disagree in this area, moving on from here.

Only time would prove…not just who is right, that is pretty obvious to many, but who wilts at the end of the day…and more importantly, why?

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.

Ringside View Of A Key Pharma Job Missing ‘The X Factor’

Just the other day, a well known doctor and a long-time friend of mine invited me for a friendly chat over lunch, after a long while. I had no option really but to accept the invite, as the warmth of his voice was overflowing.

Though the eatery, based on the ambiance and the quality of food we like, was mutually decided in his previous call, I called him again to ask whether on the pre-fixed date, about an hour earlier to the scheduled time, I can meet him first in his clinic and from there we can go together for lunch.

With a slight pause, he said, ‘No problem…but I won’t be able to talk to you there much, as I need to see all those patients with pre-scheduled appointments.”

“That’s no issue. We’ll have enough time to chat while eating. But, would you see any Medical Representatives (MRs) during that time?” I asked.

“Though my hectic schedule and other commitments don’t allow me to meet with them as much as I used to earlier…  yes, still I do meet with a few of them only two days in a week,” he took a pause, possibly to refer to his calendar and said, “Tomorrow being one those day…yes… I will… but why are you asking that?”

“I would like to just observe the MRs, while they discuss their products with you”, I literally warmed up while replying to him

“But Tapan, I don’t talk much in these meetings”, he replied somewhat apprehensively.

“Don’t worry, I shall just sit there, incognito, taking a mental note of what’s happening around, nothing more, nothing less,” I closed the call, as he did not ask any further question.

The ‘D-Day’:

On the ‘D-Day’, I entered for the first time into his well equipped and squeaky-clean clinic and saw his secretary sitting outside his office. She buzzed him immediately, as I introduced myself to her. To my utter surprise, my doctor friend came out promptly, despite his jam-packed schedule. Greeting me with his both hands and usual warmth and laughter, he took me inside, as the waiting patients were probably wondering, who is this gate-crasher? Offering a chair to me, the doctor friend smiled and said, “I couldn’t make time to meet any MR today since morning, though have kept a couple of them waiting for you to arrive, as you had desired.”

“That was not really necessary,” I quipped, “but thanks so much, nonetheless.”

The ringside view:

In a little over an hour’s time, I observed with great interest four MRs interacting with their, quite expectedly, one of the very potential customers.

Three of them were about thirtyish or below and one middle aged gentleman. Two of them came with their respective superiors. Three were quite traditional in approach. One was armed with an iPad.

I got an overall impression that the MRs were more in a hurry to conclude the call as compared to my doctor friend. Most of the interactions were more of reminder types than full detailing of any product, though all four of them had some very specialized products. I was under the impression that, at least, in presence of the supervisors, in-clinic proceedings take place with far more detail.

My doctor friend seem to be rather impatient and not quite enthused with the ongoing proceedings, but I was curious, very curious, especially when the young MR took out his iPad. I expected to see something novel on the innovative application of technology in medical communication. Probably for that reason, I was disappointed, when the young man handled the gizmo rather clumsily and used it merely to highlight some recent references on his specialized product stored in the archive.

Young looking accompanying managers of the two MRs did not appear to be live-wires, either. The participation of one of them was restricted to just handing over some medicine samples to the doctor, which the MR was passing on to him from his bag and the other just requested for prescription support for a product, as he was getting up from his chair.

While I was engrossed in the ringside view and my related thoughts, my doctor friend seemingly woke up wearing a smile, as a middle-aged confidant looking MR entered into the room. That gentleman came alone. He started his interaction recalling some events related to a trip abroad, which his boss had briefed him and conveyed to my friend how positive was the audience feedback after his speech. Informing that after the event his company has analyzed the key questions raised on the concerned product, he sought permission of the doctor to discuss top three of those questions very briefly, and he did. The doctor shifted his position in the chair several times rather awkwardly; probably because he was being so frequently referred to by the MR with lavish eulogy and that too in my presence. Though the content of the MR’s talk was not anything earthshaking, the environment that he created putting my friend on the pedestal, albeit with plain flattery, appeared to be working. He used no detailing aids, neither did he give any gift, but applied just impromptu traditional salesmanship.

This was the last MR call for us. My friend looked at me and asked, “Liked?” looking at each other both of us laughed loudly. I then stopped to ask him, “Do you prescribe the products they thanked you for prescribing?”

I am not very sure about others, but the gentleman who came last? … Yes, I do prescribe at least two of his products,” my friend replied with a disarming smile as he was standing up, looking at his watch.

He then put his hand on my shoulder and with a mild squeeze said, “Let’s step out now, rest we shall catch up on the run.”

A quick analysis:

According to my assessment, barring the last MR, none of the other three calls appeared to have interested my friend in any way, as he kept referring to his calendar, diary and other things very often, while those MRs were talking.

No wonder, my friend could not even remember prescribing any of their products. This probably means, at least three out of the four calls, made by MRs of very well reputed companies, did not leave much impact, if at all. Interestingly, two out of the four calls were from the MNCs.

Is the professional standard of MRs declining in India?

As we know, pharma industry in India is highly fragmented, with over 10,000 companies in the organized sectors and around 60,000 brands. In an environment of cutthroat competition like this, pharma players are exploring all possible means to carve out for themselves a decent share of the respective product categories, incurring average sales and marketing expenditure of around 20 to 22 percent of the total sales.

Like many other countries of the world, in India too, MRs are the most important link between the medical profession and the pharma companies. Thus, the cost of MRs takes quite a significant chunk of total sales and marketing budget of the pharma companies. There remains a huge scope for improvement though, in the realm of per MR productivity, which varies widely between the companies. For example, according to a recent report, a Sun Pharma MR on an average generated around Rs 90 lakh of business in the full year ended on March 31 2014, as compared to Rs 55 lakh of Ranbaxy, during the same period.

According to a survey conducted among both specialists and General Practitioners (GP), published in Express Pharma some years ago, out of total 30 doctors interviewed, 23 reported that quality of medical representatives visiting them has deteriorated. Only three doctors reported that the quality has not really changed, while four reported quality has improved. It was claimed by the authors that this survey result is statistically significant both on ‘t test and z test’.

The study concluded that pharma companies are responsible for this decline, as majority of them are focusing just on the end results without bothering much about the means to the end. This indicates, disproportionately more weightage is being given on the total quantum of sales rather than its quality, during performance measurement.

My above personal experience on the subject, though very short, is not much different from the above survey results, either.

The tradition continues over decades:

It appeared to me, besides new application of state-of-art technology to modernize the communication process, to ensure rapid access to all related information and to improve efficiency of tech based command and control sales & marketing management systems; basically nothing noteworthy has changed, just yet.

Interestingly, many readily available third party training programs for the MRs in the peripheral areas are springing up in large numbers with fancy claims, leaving one of the most critical issues virtually unaddressed.

I shall try to deliberate on that area now, as I see it.

‘The X Factor’:

In my view, just as the doctors are well recognized professional experts in medical care for treating patients based on evidence based science, MRs are also, supposedly, experts and a valuable source of knowledge for the medicines that their respective companies deal with, but unfortunately not regarded that way in India, generally. This is predominantly because, the doctors have accreditation for their profession that is absolutely a pre-requisite for their medical care business. Whereas, MRs do not have any such accreditation, which could formally recognize them as professionals in the knowledge-based drug/medicine business and related areas. Thus, there is somewhere a basic disconnect between the professions of the doctors and the MRs.

‘The X Factor’, in my view, is the process that facilitates requisite professional connects between the doctors and MRs, cemented by mutual professional respect, sans any kind of vested interests or needs of allurements, generally speaking.

Only with ‘The X Factor’ induced professional connects, I reckon, MRs could establish themselves as high quality source of knowledge for the drugs and disease areas that they deal with, of course, backed by regular training to hone their knowledge and skills.

This ‘X Factor’ could well be embedded into the organizational sales/marketing systems by putting in place a formal process to recognize medical representation as a respected profession.

The process of accreditation:

A structured process for Accreditation of MRs, most desirably, by involving the Government, can help achieving this goal sooner. If the Government participation is not possible for various reasons, the accreditation to MRs should come from some highly credible source, as would be accepted by the medical profession.

The process of Accreditation of MRs involves, in brief, documentation of the candidate’s basic pharma related knowledge, comprehension ability and domain specific skill sets, together with the ability of successful application of all those, while interacting with the medical profession to achieve the business goals.

The key task in the process of Accreditation is to develop modern technology based self-learning programs for the MRs that would provide basic knowledge of anatomy, physiology, pathophysiology and pharmacology together with a range of common treatments. Overall knowledge of communication and selling skills would also form an integral part of this process.

The Accreditation would ensure that the MR aspirants attain reasonable high standards for the profession that they are aspiring for. Later on, the pharmaceutical companies, who would hire them, could mold and sharpen their knowledge and skills according to company specific requirements.

Accreditation of MRs would, therefore, be a formal way to ensure that requisite high standards of the MR profession are met. Consequently, while meeting accredited MRs, the doctors would also know that they are meeting well trained and groomed, competent and credible disease area specific drug consultants. This, in turn, would help establishing requisite professional connects between the two professions based on a bond of mutual trust and respect, resulting in a win-win outcome for both.

How would the doctors recognize accredited MRs?

On successful completion of the examination for Accreditation, the individual would earn the privilege of being called an ‘Accredited Medical Representative (AMR)’, and acquire the right to put ‘AMR’ symbol next to his or her name in the business card and to wear a nice looking ‘AMR Pin’, while meeting the doctors.

Nothing much visible in this direction:

That said, not much has been effectively done, as yet, either to arrest the declining image of the MRs in the eyes of the medical profession or to make the MR profession a respectable one, except giving some extrinsic fancy job titles to them, devoid of any intrinsic value.

I am aware of some highly credible organizations, which are capable enough to give a formal shape to ‘MR Accreditation Program’ in India.

Thus the following key question arises in search of ‘The X-Factor’:

Should MRs need to have Accreditation from a credible and recognized authority in India, formally recognizing them as ‘Drugs/Medicine professionals’ and adding significant value and greater respect to the profession that they belong to?

In an earlier blog post titled “A National Regulatory Standard is necessary for MRs of the Indian Pharmaceutical Industry”, I had flagged this issue, though on a different perspective

Epilogue:

Now I get back to where I started from, in this article:

In about an hour, we were done with the lunch. However, while my doctor friend and I were eating, in track two of my brain, all those that I mentioned above were flashing by, though not in an orderly manner.

While we were in the portico of the hotel requesting the doorman to page our drivers, I thanked my doctor friend for buying me a sumptuous lunch and casually commented, “You remember the last MR?… He seems to have been really flabbergasted by your awesome speech in their conference abroad. My compliments! You have always been an excellent speaker!”

“Well…”, he quipped somewhat embarrassingly.

“Why have you reduced the frequency of meeting with the MRs?” I was curious, as those calls were a great learning experience for me, after a long while.

“Time…that’s a great constraint for me. Moreover, these meetings are like going through just motions”, he replied, while looking for his car.

Our cars arrived.

Before, I got into my car, I turned back to ask again, “Did you enjoy your foreign sojourn as a speaker for that pharma company?”

By that time the doctor friend was already in his car. Before closing the door, he looked at me again, widely smiled…somewhat naughtily, lunged forward, lowered his voice and haltingly replied, “Well…You know that…Bye for now.”

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.

A National Regulatory Standard is necessary for MRs of the Indian Pharmaceutical Industry

Medical Representatives (MR) form the bedrock of business success, especially for the pharmaceutical industry in India. The Job of MRs is tough and high voltage one, laced with moments of elation and sprinkles of frustration, while generating prescription demand for selected products in an assigned business territory. Though educational qualifications, relevant product and disease knowledge, professional conduct and ethical standards vary widely among them, they are usually friendly, mostly wearing a smile even while working in an environment of long and flexible working hours.

Currently, there is a huge challenge in India to strike a right balance between the level and quality of sales pitch generated for a brand by the MRs, at times even without being armed with required scientific knowledge and following professional conduct/ ethical standards, while doing their job.

It is critical for the MRs to understand scientific details of the products, its mode of action in a disease condition, precautions and side-effects in order to be fair to the job and be successful. As MRs are not just salesmen, they must always be properly educated in their respective fields and constantly hone their knowledge and skills to remain competitive.

A qualitative study:

Indian J Med Ethics, 2007 Apr-June; 4(2) reported a qualitative study to determine a wide range of pharmaceutical promotional practices by the MRs influencing prescription of medicines in Mumbai. The study highlighted:

An unholy alliance: Manufacturers, chemists and doctors conspire to make profits at the expense of consumers and public health, even as they negotiate with each other on their respective shares of profits”.

The paper identified misleading information, incentives and unethical trade practices as methods to increase the prescription and sale of drugs. It reported, besides other points that MRs provide incomplete medical information to influence prescribing practices.

‘Code of Pharmaceutical Marketing Practices’ is necessary, but just not enough:

Gift-giving, ethical vs. unethical promotion, transparency and self-regulation appear to be the main issues in the pharmaceutical industry right across the globe. Owing to inadequate national legislation and the lack of universally accepted self-regulatory codes, the pharmaceutical industry in India has yet to tackle the problem of alleged “Unethical drug marketing practices”.

After a protracted debate on this subject 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 sections of the media, since 2004. Be that as it may, the UCMP, in my view, is just not enough to address the issue of alleged, “Unethical drug marketing practices” holistically.

A mandatory ‘accreditation/certification’ program for MRs is the need of the hour:

Countries like United Kingdom (UK) and Australia with much longer experience of dealing with pharmaceutical industry than India, have appropriate mechanisms, safeguards and legislation in place to deal with the pharmaceutical marketing practices. Even the pharmaceutical industry in the UK and Australia have controlling authorities with comprehensive standards in place to deal with proper education, professional conducts and ethics for the MRs. Similar mandatory ‘accreditation/certification’ program for MRs, in my view, is also necessary in India without any further delay.

India should learn from others to work out a robust process:

Even with such systems and regulations in place, both in the UK and Australia, some ethical issues still remain unresolved. In Australia the largest consumer organization highlights, “that it is a conflict of interest for the Code to be administered by the industry peak body.” and “it is also concerned that the sanctions available in the Code do little to prevent breaches”. United Kingdom is no exception in this regard.

Other markets are fast catching up:

Very recently in Turkey, Turkish Ministry of Health published a new pharmaceutical promotion regulation, which specifies for the first time a certification obligation for the MRs.

In Philippines, ‘MR Accreditation Program (MRAP)’ started about 8 to10 years ago. MRAP is administered by the Pharmaceutical and Healthcare Association of Philippines. The certifying examination is accredited by the Professional Regulation Commission (PRC) under its Board of Pharmacy of the Government of Philippines.

In Japan there is a certification program for the MR since 1997, which is administered by the MR Education and Accreditation Center of Japan, a public service corporation. One has to receive over 450 hours education and training in Japan to be qualified for the examination. Even after being qualified in the certification examination, at least 50 hours of continuing education is required every year to keep the certification updated that expires after 5 years.

In Germany, under German law and practice, MRs have either the status of “pharma advisors” (“Pharmaberater”) as specified in German Drugs Act or they have to pass the examination for certified MRs (“Pharmareferent”), which is accessible online.

“Pharma Advisors” have science background as a pharmacist, chemist, physician, veterinarian etc. whereas other MRs are required to obtain scientific and medicinal knowledge through suitable education and training program, which will lead to an examination for certification by the German authorities. All MRs are required to start the program within 6 months of employment in the industry and complete the five modules within 2 years.

In Canada ‘the Code of Ethical Practices’ requires the MRs to complete an accreditation course offered by the Council for Continuing Pharmaceutical Education within two years of commencing their employment.

In USA, there is no official MR certification program.

In Hungary, the MR certification program is administered officially by the Health Authority of the country.

In Indonesia, this is administered officially by the state/ governmental bodies or by the industry through an outside consulting organization, which issues certificates after successful completion of the examination.

In Argentina, MR Certification Program is required by the law of the land. In order to include the name in the ‘Registry of MR’, a qualifying degree as medical sales representative, issued by a tertiary educational institution and/or officially acknowledged training institutions, is essential.

In South Africa, they have certification only for marketing code training, which is administered by an independent Marketing Code Authority.

In Sweden, this course is administered by an external course organizer on behalf of LIF Sweden.

However, Swedish companies nowadays prefer to employ pharmacists, who do not need to take the examination.

A National regulatory standard for MRs is necessary in India:

India is now one of fastest growing emerging pharmaceutical markets of the world with 3rd global ranking in volume of production and 13th in value terms. Domestic turnover of the industry is around US$ 12.1 billion in June 2011 (IMS) representing just over 1% of the global pharmaceutical industry turnover of US$ 850 billion (IMS). Since 1970, Indian pharmaceutical Industry has rapidly evolved from almost a non-entity to meeting around 20% of the global requirements for high quality and low cost generic medicines.

Unfortunately, despite a fast evolving scenario, appropriate regulations in various areas of the industry in India have not been worked out, as yet, to derive the best mileage out of this scorching pace of growth of the industry. India still does not have a national code of conduct or regulatory standards applicable to MRs.

Only the clause 4 of ‘The Magic Remedies (Objectionable Advertisement) Act, 1954’ deals with misleading advertisements. It is about time to formulate not just a national code on pharmaceutical marketing practices, but also a mandatory accreditation program and qualifying criteria for the MRs for entire pharmaceutical industry in India, like many other countries of the world.

Central Drugs Standard Control Organization (CDSCO) of the Ministry of Health and Family Welfare of the Government of India in its website lists the “Laws Pertaining to Manufacture and Sale of Drugs in India”. However, it does not specify any regulation for the MRs nor does it recommend any standard of qualification and training for them, which is so critical for all concerned.

Conclusion:

In the above scenario, the moot question is without any comprehensive and formalized uniform national standards of educational qualification, knowledge, ethics and professional conduct being in place for the MRs, are they getting right uniform inputs, across the board, to appropriately interact with the medical profession in a manner that will benefit the patients and at the same remain within the boundary of professional conduct and medical ethics?

Thus, a National regulatory standard for MRs, I reckon, is absolutely necessary in India… sooner the better.

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.

‘Prescription-brand’ loyalty and engaged field force – exploring the direct relationship.

Well known English writer and one of the most prominent members of the famous ‘Huxley family’, Aldous Huxley once said in the context of nature, “Everything has a cause and the same cause usually produces same effect. The law of cause and effect is fixed.”
‘Cause and effect’ relationship between ‘employee satisfaction’ and ‘customer satisfaction’:Following such ‘cause and effect’ relationship, there are many studies, which establish a direct correlation between ‘customers satisfaction’ and ‘satisfied employees’. Within the pharmaceutical industry, it has now been well established that there is a cause-and-effectrelationship between Doctors’ prescription-brand loyalty and a satisfied or properly engaged sales & marketing staff.

For most organizations, the objective of improving the satisfaction level or increasing the degree of engagement of an employee in the organization is an article of faith. Research studies on this subject indicate that building customer loyalty has a significant impact on profitability of the organization. A study based on 46,000 business-to-business surveys reports that a “totally satisfied” customer contributes 2.6 times more revenue than a “somewhat satisfied” customer.

‘Walking the talk’ is the name of the game:

It is extremely difficult if not impossible to create a critical mass of loyal doctors’ base for a brand or brands without a creating a team of satisfied, engaged or loyal sales & marketing team. The best employees usually prefer to work for companies where managers ‘walk the talk’, set examples and deliver superior values.

Acid test of leadership:

A work environment of such kind helps to create employee satisfaction, loyalty and engagement, which ultimately gets translated into building customer loyalty. Ensuring employee loyalty and creating employee satisfaction is, therefore, considered widely as the acid test of leadership.

Creating a positive psyche within employees is important, usual skill training is just not enough:

To create employee loyalty the organization will need to understand the mind of its employee and always try to have a positive influence on their psyche. Usual skill training will not help to achieve it.
Just as sowing a seed is no guarantee that it will grow into a plant, a highly skilled sales person is no guarantee that it will contribute to the growth of the organization. Just as one will need to create an environment for the seed grow into a plant, the organization will need to create an environment for employee satisfaction to enable them contributing towards the growth of the organization.

In HR invest resources where the mouth is:

It is very important for the managers to devote more resources both in terms of money and time to play the role of a mentor to each one of his or her direct reports to improve their satisfaction level with the organization. These satisfied employees will in turn help create a core group of prescription brand loyal doctors for the organization.

‘Charity begins at home’:

However, ironically most of these managers do not realize that attempts at their end towards this objective, many a times, are just cosmetic in nature. As the saying goes, “charity begins at home”…real enhancement in the level of customer services, indeed starts from extending superior services, support and satisfaction level to the sales force, the bedrock for generation of prescription demands for the prescription brands.

Facing the ‘moments of truths’ of every day positively:

Pursuit of an organization in providing great services to the patients through doctors ultimately depends on the people who provide those services…the sales force. It can only happen through one’s willingness to go beyond what is required of people who serve on the front lines.

Excellence in organizational performance takes place through efforts of frontline employees who make up their minds to face the “moments of truth” of every day, as positively as they possibly can. Such enthusiasm, loyalty, or devotion none will be able to impose on any one. These ordinary people are transformed into ‘brave hearts’ and highly satisfied top performers only through well articulated “shared values”, which take their deep roots within the organizational environment. In a situation like this one can easily make out the visible passion and pride of the frontline staff, emanating from deep within, of each one of them.

Some research findings:

Following are some examples from various research findings, which reinforce the hypotheses that there is a ‘cause and effect’ relationship between ‘customers satisfaction’ and ‘satisfied employees’:

• “For every one percent increase in internal service climate there is a two percent increase in
revenue”.

• “In cardiac care units where nurses’ moods were depressed, patient death rates were four times
higher than in comparable units”.

• Emotional commitment of the sales force and sense of identity with the company are key factors in
providing excellent service to the doctors.

• The reason of poor prescription demand of a company’s products is related to the degree of its sales
staff turnover.

Conclusion:

Therefore, one tends to believe that “a company’s external customer service is only as strong as the company’s internal leadership and the culture of commitment that this leadership creates”.

To transform one’s organization from “Good to Great” it is of utmost importance to build a team of loyal and satisfied ‘internal customers’ by creating a commensurate organizational culture, work environment, ethics and values. Various training & development programs or seminars, aiming only at employee ‘skill development’, are just not enough.

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.