Ethical practices in pharma

M.PHARM + MBA (QUALITY ASSURANCE) SEMESTER II (2015-2016)

SPP SCHOOL OF PHARMACY AND TECHNOLOGY MANAGEMENT 1 | P a g e

BACKGROUND Indian pharmaceutical industry has been witnessing remarkable growth over past few years. It currently tops the chart amongst India's sciencebased industries with large ranging capabilities in the complex field of drug manufacture and technology. A highly organized sector, the Indian pharmaceutical industry is estimated to be worth $ 4.5 billion, growing at about 8 to 9 percent annually.

India is now among the five pharmaceutical emerging markets. There will be new drug launches, new drug filings, and Phase II clinic trials which are expected during this year (2016). The domestic pharmaceutical market is expected to register a strong doubledigit growth of 18-19 per cent in the coming times. In the present article we enlist the key features of the Uniform Code of Pharmaceuticals Marketing Practices.

The quality of UCPMP: The UCPMP draft document is well written, balanced and by and large 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.

Draft UCPMP does not seem to pose any major extra restrictions to the pharmaceutical companies as compared to the MCI guidelines. All concerned should welcome this decision of the DoP, as the same ethical standards will now be applicable to all small, midsized and large pharma players , equally. The main focus of the DoP should be in ensuring that all companies across the pharmaceutical industry follow these welldefined standards in their marketing practices and interactions with the doctors. The draft UCPMP 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 the pharmaceutical companies are expected to keep these detail records and how long? It is also not clear whether such records have to be maintained on file by the individual companies and supplied to the DoP only on specific requests for the same or all these details are expected to be disclosed on a regular basis to the regulator. The draft UCPMP indicates that industry associations must upload full details of received complaints on their respective websites. Although this provision could help making the system 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 marketing code.

Topic- Ethicality in pharmaceutical marketing practices in India- Response from various stakeholders. (Steps taken & likely to be taken in pharmaceutical ethical practices.)



Skepticism with the UCPMP: Some are quite skeptical about the effectiveness of UCPMP in containing unethical marketing practices within the Indian Pharmaceutical Industry.

This section of people believes, with thousands of pharmaceutical companies operating in India, just selfcontrol with UCPMP without any properly enforceable stringent Government regulation, will simply not work.

The issue: The entire issue arises out of the key factor that the patients do not have any say on the use/purchase of a medicine brand/brands that a doctor will prescribe. It is generally believed by the civil society that doctors predominantly prescribe mostly those brands,which are promoted to them by the pharmaceutical companies in various ways. Thus, in today’s world and particularly in India, the degree of commercialization of the noble healthcare services, as reported quite often by the media, has reached a new high, sacrificing the ethics and etiquette both in medical and pharmaceutical marketing practices at the altar of unlimited greed, want and conspicuous consumption.

‘The Times of India’ also reported the following in its December 15, 2008 edition: “1. More drugs a doctor prescribes of a specific company, greater are the chances of his/ her winning a car, a highend fridge or a TV set. 2. Drug companies dole out free trips with family to exoticdestinations like Turkey or Kenya. 3. In the West, unethical marketing practices attract stiff penalties.4. In India, there are only vague assurances of selfregulation by the drug industry and reliance on doctors’ ethics”. Thus, it has been quite a while from now, serious concerns are being 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.

A global phenomenon: Since quite some time, this issue has indeed become a global phenomenon. Many countries, including India, are taking note of such examples of socioeconomic decay, that too in the healthcare sector. Just the other day, the July 4, 2012 edition of ‘The Guardian’, while reporting that GlaxoSmithKline has agreed to pay $3bn (£1.9bn) to settle a series of old criminal and civil investigations by the US authorities into the sales and marketing of some of its bestknown products, commented, “GlaxoSmithKline’s bribes are evidence that Big Pharma isn’t working – the inadequacies of relying solely on market forces for our drugs are clearer than ever. This scandal should prompt a rethink.”

The Guardian further commented: “After all, this has happened before. All the giants – AstraZeneca, BristolMyers Squibb, Merck, Eli Lilly, Pfizer – have been investigated for bribery. One of the most notorious episodes of misconduct involved Merck’s anti-inflammatory drug Vioxx, withdrawn in 2004 after the company persistently played down its risk of causing cardiovascular problems.” The New York Times (NYT) in its April 12, 2010 edition in an article titled, “Data on Fees to Doctors is Called Hard to Parse”, reported that though some big pharmaceutical companies have started disclosing payments to doctors who act as consultants or speakers, many still find it far too difficult to follow the money trail.

NYT reported in the same article, “Senate researchers have found that some prominent doctors at academic medical centers have failed to disclose millions of dollars in drug company payments, despite university



requirements that they do so. Federal prosecutors say some payments are really kickbacks for illegal or excessive prescribing”.

UCPMP Framework



The Principles of Good Marketing Practices which indian pharmaceutical must be pursue.

General Marketing practices should never be such as to bring discredit upon the Indian pharmaceutical industry. Companies should establish and maintain appropriate procedures to ensure full compliance of Good

Marketing Practices. All promotional material for new products should have complete prescribing information based on the

format of Physicians Desk Reference. Later, a succinct statement of the side effects, precautions and contraindications relevant to the

indications generally termed as the abridged prescribing information should be given in all printed promotional material.

Promotional material should conform, both in text and illustration, to canons of good taste and should recognize the professional standing of the recipients.

Companies should use complete candor in dealings with healthcare professionals. Good marketing practices should therefore be evidence based which can benefit the final consumer the

patient.

Product Promotion Promotion should encourage the appropriate use of products by presenting them objectively on the

basis of valid scientific evidence and without exaggeration. (For instance, a combination of amoxicillin and clavulanic acid should be promoted only after microbiological tests and never as firstline treatment.)

Promotion should not be disguised. Pilot studies orpostmarketing surveillance must be conducted with the primary scientific purpose of pharmacovigilance.

Unapproved indications (offlabel indications) should not be promoted. Unqualified superlatives should not be used in sales promotional material. Comparative statements, tables, charts must be used carefully. Medical ethics should be adhered to. Products, activities or representatives of other pharmaceutical companies must not be disparaged. The medical and scientific opinions of Key Opinion Leaders and other healthcare professionals must

not be disparaged. Doctors' names or photographs must not be used in any way that is contrary to medical ethics. If any new side effect or drug interaction is generated that significantly changes the safety and/or

efficacy information of a product, then all promotional material must be updated and immediately communicated to all concerned.

Postmarketing surveillance (PMS) studies should be conducted for products being introduced for the first time in India solely for the purpose of pharmacovigilance and not for product promotion.

Gifts Inappropriate financial or material benefits, including inappropriate hospitality, should not be offered

to doctors to influence them to prescribe the companyâ s products. Inappropriate gifts or financial inducement should not be offered or given to doctors or paramedics for

the purpose of getting prescriptions or product usage. For instance, a mercury thermometer or a hand sanitizer to a doctor may be an appropriate gift.



Payments in cash or cash equivalents (such as gift vouchers, prepaid credit cards) must not be offered to doctors either directly or indirectly.

Exceptional gifts during various festive seasons should be symbolic and modest, For instance, a small box of dryfruits during Diwali could be appropriate.

Text or reference books, subscription to online journals and other educational materials may be given to health care providers if they serve a genuine educational function.

Sponsorship Symposia, CMEs and similar events are indispensable for the dissemination of knowledge and

experience. Scientific objectives should be the principal focus in arranging such meetings. Entertainment and other hospitality should not be inconsistent with these objectives.

No payments should be made to compensate doctors for time spent in attending such events. Any support provided to individual healthcare professionals must not be conditional upon any

obligation to prescribe, recommend or promote any pharmaceutical product. When a medical body (such as APICON or ANCIPS) sponsors a conference, the sponsorship from a

pharma company must be able to withstand public and professional scrutiny and conform to the professional standards of ethics and good trust.

Invitations to such meetings should not be extended to spouses unless they themselves are practising members of the medical or allied profession.

When a symposium sponsored by a pharmaceutical company based in India is to be held in an overseas location, at least 80% of the attendees should be from the country in which the symposium is held.

When a symposium is organized, a minimum of 90% of time should be spent on core activities.

Training the Field Staff Medical representatives and the field managers must be adequately trained and possess sufficient

medical and technical knowledge to present information on their company's products in an accurate, responsible and ethical manner.

Training is not a onetime event. The training given to medical representative and the field managers should be an ongoing process.

Medical representatives should ensure that the frequency, timing and duration of calls, together with the manner in which they are made, are such as not to cause inconvenience to the doctors.

Clinical Trials Clinical trials should be conducted to evaluate the efficacy and safety of medicines. The protocol for clinical trials should be in accordance with the guidelines set by WMA Declaration of

Helsinki and the Belmont Report. In chronic therapy clinical trials, the participants in the clinical trial should receive a continuous supply

of the medicine till such time it is commercially available. Participants in clinical trials should be mentally stable and be aware that they are the subjects of a

clinical trial. Unfavorable and negative reports too should be published in journals â not just favourable ones. Transparency of clinical trial data should be observed in the best interest of the patients who use them

and doctors who prescribe them.



Conclusion: In all countries and India is no exception, pharmaceutical companies, by and large, have been articulating that they try to follow the legal ways and means to maximize turnover of their respective brands. Many of them do follow transparent and admirable stringent selfregulations, stipulated either by themselves or by their industry associations. ‘Selfregulation 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 in India? It appears, immediately after the Department Related Parliamentary Standing Committee on Health and Family Welfare presented its 58th Report on the action taken by the DoP on the recommendations / observations contained in the 45th report to both the Lower and the Upper houses of the Parliament on May 08, 2012, the DoP has reportedly taken an extra step forward towards this direction last week. The amended MCI regulations for the doctors coupled with the notified UCPMP for the entire pharmaceutical industry should make the financial transactional relationship between the physicians and the pharmaceutical industry in India clean and transparent. It was also reported last week that Government will soon decide whether there will be an independent industry appointed ‘Ombudsman’ for the enforcement of UCPMP across the country or the implementation of the code will strictly be monitored under the Government control. It is worth reiterating that the draft UCPMP very categorically warns, in case the selfcontrol With UCPMP by the industry appointed independent ‘Ombudsman’ does not work effectively, the Government would seriously consider making it statutory for the entire pharmaceutical industry of India. This is indeed quite a strong signal from the government to the industry for ‘Shaping Up’… sooner the better. The popular dictum, especially used by the healthcare industry, “patients’ interest come first”, 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, as “Pharmaceutical Marketing Malpractices are Proven Barriers to Healthcare Access”. Reference

http://www.livemint.com/Industry/9bFTJSchdr4cmxkWViUsqK/Govt-may-bring-pharma-marketing-under-statutory-ethics-law.html

http://www.sciencedirect.com/science/article/pii/S0970389612001231 http://www.theenablers.org/white-paper---good-marketing-practices.php http://brandcare.net/blog/2012/01/17/ethical-matters/ http://www.frost.com/prod/servlet/market-insight-print.pag?docid=MKEE-59QUU4 http://www.issuesinmedicalethics.org/index.php/ijme/article/view/776/1853

http://www.livemint.com/Industry/9bFTJSchdr4cmxkWViUsqK/Govt-may-bring-pharma-marketing-under-statutory-

http://www.sciencedirect.com/science/article/pii/S0970389612001231

http://www.theenablers.org/white-paper---good-marketing-practices.php

http://brandcare.net/blog/2012/01/17/ethical-matters/

http://www.frost.com/prod/servlet/market-insight-print.pag?docid=MKEE-59QUU4

http://www.issuesinmedicalethics.org/index.php/ijme/article/view/776/1853

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Ethical practices in pharma