Final White Paper on GMaP 27 April 2014.pdf Final White Paper on GMaP 27 April 2014.pdf
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White Paper on Good Marketing Practices for Pharmaceutical Industry Worldwide

Table of contents

  • Executive summary
  • Introduction
  • Current status of marketing practices in India
  • Future of marketing in the Indian pharma industry
  • The Principles of Good Marketing Practices

Executive Summary

This White Paper from The Enablers€™ is to help the pharma industry restore its past glory and the dignity of the profession of pharmaceutical selling. This in turn can attract talent. The challenge is immense as the country has around 24000 pharma companies of which only about 330 are in the organized sector.

 While every pharma company is entitled to promote its products and build brands, pharma companies should not divert the marketing budgets for brand building to other forms of sales promotional activities which can raise some eyebrows. The current pharma marketing practices in India replicate the practices adopted by the western world, from where modern medicine has evolved. This does not exclude some of the unhealthy marketing practices in vogue in the western countries as is evidenced by R. Moynihan in the British Medical Journal 326: 1189-1192 (2003) and A. Wazana in JAMA 283: 373-80 (2000). This calls for a 180 degrees change. Some of the issues which need to be addressed immediately are 'transactional marketing'; 'disease mongering'€™; misleading product promotion; and irrational drug combinations.

Pharma marketing strategies have not changed substantially in the last fifty years. Pharma marketers keep on doing what they have been doing for half a century. Time is apt for a change or else become extinct. Pharma marketers need to look at newer and modern strategies and apply the principles of evidence-based and patient-centric marketing. The critical objective should be to eliminate the practice of insanity in pharma marketing.

Pharma India should be conscious of its special position in the healthcare services in India, and should conduct its marketing and sales activities in a truthful, honest and trustworthy manner.

This can be done by adopting Good Marketing Practices as discussed in the White Paper.

Introduction

The challenge of getting pharma marketing right in India is growing. The aim of this White Paper is to revolutionize the current Indian pharma marketing practices and lay down guidelines and the principles for Good Marketing Practices for the pharmaceutical industry. This White Paper should mark the commencement of a social movement in India to establish a healthy and symbiotic relationship between the pharma and the medical professionals. The Enablers€™ will play the role of a 'thought leader & change leader'€™ for the pharma industry. 

Statement of the problem

Every pharma company is entitled to promote its products and build brands. Of late, quite a few pharma companies divert the marketing budgets for brand building to other forms of sales promotional activities which can raise some eyebrows. Some of these promotional activities include unethical practices of offering gifts not related to the medical profession, bribing the medical professionals through free lunches & dinners, jaunts & cruises - all in the name of CMEs and medical conferences. Very often pharma companies offer multiple gifts to influence the doctor'€™s prescriptions; although many doctors deny its influence despite considerable evidence to the contrary. Concerns over the influence of pharmaceutical gifts on physicians have surged in recent years. (1) Gifts associated with pharmaceutical detailing are motivated by a single goal - to increase the sales of a company'€™s products. There is no ethical basis for allowing these types of financial exchanges to continue. (1) The number of gifts that doctors receive correlate with beliefs that drug representatives have no impact on prescribing behavior. (2, 3) The ultimate burden is on the end consumer – the patient. Evidence based pharma marketing is one ideal path to tread. Evidence-based medicine is the conscientious, explicit, and judicious use of the best current evidence in making decisions about the care of individual patients. (4) As the awareness of the patients is increasing, evidence based pharma marketing can result into creation of value for our customers – both doctors and patients.

Good marketing practices should therefore, be evidence based, which can benefit the final consumer – the patient. By shifting gears, pharma companies can do a lot for the improvement for the medical professionals. Pharma can help medical professionals to improve the quality of their practice. Patients will benefit by reduced costs of drugs by lowering the marketing budgets. Pharma companies need to adhere to good and healthy marketing practices which not only guarantee sales but can add value to society.

Pharmaceutical marketing practices - time for change

Pharma marketers in India are stuck in a time warp – they keep on doing what they have been doing for half a century. The current marketing practices in India replicate the practices adopted by the western world, from where modern medicine has evolved. This does not exclude some of the unhealthy marketing practices in vogue in the western countries. In May 2003 the British Medical Journal devoted a special edition to the relationship between doctors and pharmaceutical companies titled “Time To Untangle Doctors From Drug Companies” (5). The theme was relationship between the medical profession and the pharmaceutical industry.  In this article, a journalist based in Washington, DC, Ray Moynihan explored the brewing conflicts at one of the world's leading medical campuses as it joined the wider global debate about how to redefine relations with big pharmaceutical companies.

In India, too, doctors and drug companies are entwined in a web of interactions which are contentious. Various forms of currency are used to lure the medical professionals to alter their prescriptions habit. Offering dinners, expenses for travel or accommodation, financing medical conferences and CMEs is common, for getting enhanced prescriptions for the products. Doctors attend company sponsored events providing Continuing Medical Education. Medical professional societies rely heavily on industry sponsorship of their events. Medical journals rely on pharmaceutical company funded advertisements, company purchased reprints, and company sponsored supplements. The marketer knows that gifts, lunches and jaunts do establish reciprocity!

Pharma companies which spend liberally on sales promotion via dinners, jaunts and gifts need to recoup the money spent, which more often than not results in high cost of therapy to the ultimate user -€“ the patient. Besides, companies offer trade incentives to the retailers and the wholesalers, the cost of which is ultimately recovered from the final victim, the hapless patient, who has no say in the purchase.

The patient thus becomes the eventual whipping boy.

The time for change is here and it is imminent.

Bad marketing practices and bad training contribute to pharma’s bad reputation

Pharmaceutical sales was considered a respectable profession a few decades back where the doctor waited for the medical representatives to gain valuable updated information on medicine and enrich his knowledge. Today, poor quality of field personnel coupled with lack of training has reduced the dignity of the pharma selling profession. Ambitious sales targets but lack of a well trained field force makes pharma companies take chaotic shortcuts to attain their goals - through poor marketing practices!

The invisible cost of poorly trained personnel and the resulting substandard image has not been appreciated by many in the industry. The most important and critical job is seeing that the sales force is properly trained. Besides mastering a host of selling skills, today medical representatives must be thorough with their products and that of competitors. Improper sales training can result in the waste of hundreds of thousands of rupees every year through prescriptions going to the competitors. The better trained sales force can pre-empt this loss of potential sale besides enhancing the image of the company and of the industry too. In addition medical representatives may find themselves unprepared to perform their jobs satisfactorily, become discouraged and leave the company. Top quality sales training helps reduce the rate of turnover and recruitment costs drop as the overall efficiency of the company rises. Every human being wants to develop and so do the pharma sales personnel. If opportunities are not available within the organization they would look for those organizations which provide these opportunities resulting in avoidable attrition.

Many companies try to offset these costs through bribes and other unethical marketing practices. 

Why this White Paper and what it is all about

The medical profession in Europe, in conjunction with many social movements, has begun to consider seriously the appropriateness of current relationships between Big Pharma and the medical professional. This White Paper from 'The Enablers' is to commence a social movement in India whereby in marketing campaigns the focus is based on evidence based medicine. To borrow and rephrase Neil Armstrong'€™s famous words: 'This White Paper can be a small step in the mankind'€™s fight against unethical pharma marketing practices.'

Current status of marketing practices

How are drugs promoted in India?

Aggressive pharma promotion with a clear aim to modify the prescribing habits of physicians is the norm of the Indian pharmaceutical industry. Promotions may also subtly encourage self-medication. Promotion involves informational and persuasive activities to induce prescriptions. It includes the activities of medical representatives, advertisements in journals, provision of gifts and samples, holding conferences, symposia and scientific meetings, sponsoring medical education and conducting promotional trials. Companies have the right to promote their products, but they should do so in a fair, accurate and ethical manner. The promotional claims need to be reliable, truthful, informative,balanced, up-to-date, and capable of substantiation. (6) Currently many companies do not adhere to these ethical principles. Hence, in most situations, these lead to irrational and unnecessary use of drugs. This is unfortunate. Patients are locked out either by tradition or by design. (7) Doctors and patients make decisions together when medical practice is at its best (7). This is where the Indian pharma can be a bridge between the doctors and patients through patient-centric marketing backed up by evidence-based marketing. In fact the marketing code of Indian Drug Manufacturers Association (IDMA) says: 'All promotional activity should primarily entail a benefit to patients'€ (8)   

Identifying the negative impacts of the current practices

  • Disease mongering (Or selling sickness)

This is perhaps the dirtiest way to market a product in the name of creating social awareness.  A lot of money can be made from healthy people who believe they are sick!  Some forms of medicalising ordinary life may now be better described as disease mongering: widening the boundaries of treatable illness in order to expand markets for those who sell and deliver treatments. (9) Pharmaceutical companies sponsor diseases and promote them to prescribers and consumers.Disease mongering is the opportunistic exploitation of both a widespread anxiety about frailty and a faith in scientific advance and '€œinnovation'€ - a powerful economic, scientific, and social norm.(10) Hepatitis B and dyslipidemia are some of the 'industry-promoted' ailments. 

  • Misleading promotional material

This is another dangerous and anti-social activity being pursued by Indian pharma marketers. Organizations like OPPI and IDMA have drawn up their own codes of ethics for their members but these remain more on paper than in practice. Companies are known to even flout their own code of conduct. For example OPPI Code 2012 says: “No pharmaceutical product shall be promoted for use until the requisite approval for marketing for such use has been given.” Yet, many pharma companies on the sly promote drugs for off-label use. (11) Clonazepam, for example, is indicated only as an adjunct in seizure disorders and in panic disorders. But pharmaceutical companies in India aggressively promote it in Generalized Anxiety Disorders (GAD). (12)

  • Irrational Drug Combinations

The supply of new chemical entities is drying out rapidly. The world pharma industry is concerned about this but not the pharmaceutical industry in India; thanks to the ingenuity of the Indian pharmaceutical marketers. Irrational fixed drug combinations (FDCs) which do not stand the scrutiny of WHO guidelines are in abundance in the Indian pharma industry.  â€œIrrational FDCs are prescribed by all the departments. Physicians were ignorant about the essential drugs and FDCs.” (13) Often drugs withsupra-additive toxicity of the ingredients are also promoted as rational combinations. Combinations of NSAIDS/analgesics with antispasmodic agents are also available in India. They are not only irrational but also could be dangerous. (14, 15)  This is where the Indian pharmaceutical marketers can display maturity and shun such irrational fixed drug combinations, adhere to the code of marketing laid down by IDMA and eradicate the menace of irrational FDCs. (8)

Some of the available evidence about doctors’ prescribing habits

  • Most doctors deny that gifts from the industry influence their prescribing.(3)
  • Receiving a gift and the number of gifts received correlated with the belief that pharmaceutical representatives have no impact on prescribing behavior; receiving gifts of high relevance to practice was also associated with a positive attitude.  (3)
  • 80%–95% of doctors see industry representatives regularly. (5)
  •  More frequent contact is linked to unnecessary prescribing and to increased use of new drugs. (3, 16)
  • Attendance at sponsored conferences is associated with increased prescribing of the sponsor'€™s product. This increase can be seen for the next 6 months. (3)

Future of marketing practices in the pharma industry

What needs to happen?

Pharma companies should apply the principles of evidence-based marketing in their strategies.  The critical objective should be to eliminate the practice of insanity in pharma marketing i.e.€“ employing the same strategies and tactics again and again, cycle after cycle, year after year and then expecting different results. Evidence-based marketing would include interaction with the medical professionals to help them to prescribe to patients the right medication based on the best available medical science, keeping the larger interest at heart.

Role of pharma groups like IDMA / OPPI / IPA

Current relationships of the pharma companies with the medical professionals are eroding public respect for both the industry and medical professionals. Social media appears to be a watchdog. Further loss of public trust can threaten to undermine the future of the industry in the eyes of the general public. The guidelines from IDMA / OPPI / IPA do not seem to be a meaningful driver of professional change. Perhaps it is time for these pharma bodies to develop professional enforcement or reward mechanisms for compliance with ethical standards.  For example, any company which practices achieving a level of compliance can receive special professional recognition and earn public accolades. 

Opinions of the medical professionals

Some doctors are taking up the fight against corruption in Indian medicine, which many observers claim is widespread in the country. Dr. K. K. Aggarwal, a Delhi-based physician on the ethics committee of MCI, says there's no method at present to document the percentage of doctors taking kickbacks, but he admits that the practice exists.(17) Dr. S. K. Sarin, former MCI chairman, defends MCI. “The MCI rules are quite robust, but enforcement is a problem. In my time, we cracked down on plenty of doctors for misconduct. The ethics committee used to take legal action on its own in response to tip-offs. There were several instances of doctors making their own foundations and getting donations from pharma companies, accepting foreign trips for themselves and their families. These were thoroughly investigated and due to the fear of strict and speedy action during our term, the menace was reduced significantly.” (17)

To deal with the problem of bribes by drug firms, MCI added several new amendments to its code of ethics in 2009. However, C. M. Gulhati, editor of Monthly Index of Medical Specialities, India, says, "At most, the code will suspend or cancel the licence of the doctor violating the code, but it cannot do anything to stop pharma companies from offering doctors gifts because they fall outside the purview of the code."€ He said a lack of a drug company regulator is a big concern.(17)

Pharma companies should respond to the public pressure and of the right-minded medical professionals to stop paying doctors to promote their products through speaking engagements as in medical conference, symposia and CMEs. Every company should end linking compensation for its field force to the number of prescriptions doctors write. Instead, alternative methods of rewards should be explored. The onus is on the pharma companies to adopt Good Marketing Practices. Some countries have enacted 'sunshine laws' that require pharmaceutical companies to disclose payments or gifts to physicians. (18)Probably such an act is required in India, too.  While governmental regulatory actions are needed, the medical profession needs to reclaim its professional independence from industry's unethical pressures. Current relationships are eroding public respect for medical professionals; further loss of social trust threatens to undermine the profession'€™s future. (18) The pharma industry is greatly responsible for this.

Responses from doctors on pharma promotion

There are a number of key reasons for concern about the impact of pharmaceutical companies marketing strategies. These include the fact that drug promotion is often misleading. Besides, the risk of disease mongering remains, say doctors. New drugs are the ones most heavily promoted and these are the ones with the least well-understood safety profiles. (19)  Doctors are obviously not undiscerning recipients of advertising and other forms of promotion. R. Smith says, "Your opinion may not be bought, but it seems rude to say critical things about people who have hosted you so well."€ He goes on to say that the easy dichotomy of pharmaceutical giants as villains and doctors as innocent victims is over-simplifying the situation. Sampling of products is one area which needs immediate attention.(20) 

"I don'€™t value samples at all!" is the overwhelming response of 23 of 25 doctors (92%) who were interviewed informally by 'The Enablers'€™. If at all samples have to be given, they need to be given for new products and for the full therapeutic duration for acute therapy and at least till such time the patient shows signs of good prognosis in case of chronic therapy. Yet pharma companies continue to use the 1970€™s method of brand promotion.    Obviously firms who spend that kind of money need to recoup their costs.

The authors suggest that the pharmaceutical industry should set up self-regulating bodies in this vital area since misleading/inaccurate pharmaceutical promotion can have very serious impacts on the populace.

See how authentic€™ the Indian pharma promotional materials are!

'€œA total of 134 promotional leaflets given to medical practitioners were collected. Out of these, 102 satisfied the inclusion criteria and were subjected to analysis. The analysis showed that as many as 20% of the claims were exaggerated, 32% were inconclusive, 17% were false and only 21% were authentic. In 10% of the leaflets, original data from literature was misrepresented to suit the therapeutic claims made.'€ (21)

Good Marketing Practices for the Pharmaceutical Industry 

Pharma India should be conscious of its special position in the healthcare services in India, and should fulfill its obligations in a free and fully responsible manner. Pharma India should have its own internal standards or follow the marketing codes set up by W.H.O., OPPI or IDMA. Every company should have its own marketing practices manual and ensure that the contents are followed rigidly. The marketing manual prepared should be in keeping with the spirit of the Prof. Chitta Mitra Oath.

Here are some Good Marketing Practices which Pharma India must 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 first-line treatment.)
  • Promotion should not be disguised. Pilot studies orpost-marketing surveillance must be conducted with the primary scientific purpose of pharmacovigilance.
  • Unapproved indications (off-label 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.
  • Post-marketing 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 company’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 dry-fruits during Diwali could be appropriate.
  • Text or reference books, subscription to on-line 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 on-going 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 - not just favorable ones.
  • Transparency of clinical trial data should be observed in the best interest of the patients who use them and doctors who prescribe them. 

Finally, every pharma marketer should swear by the Prof. Chitta Mitra Oath and abide by it. [Please log on to: http://www.theenablers.org/tribute-to-my-guru-prof-chitta-mitra.php]

References

  1. J Gen Intern Med. 2010 January; 25(1): 79–83. [A]
  2. MJA 2004; 180: 409-410 [B]
  3. Wazana A. Physicians and the pharmaceutical industry, is a gift ever just a gift? JAMA 2000;283: 373-80. [PubMed]
  4. David L. Sackett, et al., BMJ 1996; 312:71
  5. Moynihan, R. (2003) “Who pays for the pizza? Redefining the relationships between doctors and drug companies. 1: Entanglement” British Medical Journal 326: 1189-1192
  6. Kumar CJ  et al J Assoc Physicians India. 2001 Feb; 49:266-73.
  7. Gold acre Ben. Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients. Harper Collins, Northamptonshire, 2013
  8. IDMA: Marketing Code for Pharmaceutical Industry - 2012
  9.  BMJ 2002;324:886.1
  10. Moynihan R, Henry, D (2006): The fight against disease mongering: Generating knowledge for action. PLoS Med 3(4): e191.
  11. OPPI Code of Pharmaceutical Practices 2012
  12. RxList. http://www.rxlist.com/klonopin-drug/indications-dosage.htm
  13. Int J Basic Clin Pharmacol. 2013; 2(4): 347-352
  14. Gulhati CM. Monthly index of medical specialties, India. MIMS INDIA. 2005;25:81–94.
  15. Br J Clin Pharmacol. 2008 May; 65(5): 795-€“796.
  16. Watkins C, Moore L, Harvey I, et al. BMJ 2003; 326: 1178-1179
  17. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)62364-8/fulltext)
  18. Ross JS et al.. Pharmaceutical company payments to physicians: early experiences with disclosure laws in Vermont and Minnesota. JAMA. 2007;297:1216–1223. doi: 10.1001/jama.297.11.1216.)
  19. http://ejbo.jyu.fi/pdf/ejbo_vol9_no2_pages_4-11.pdf in EJBO Electronic Journal of Business Ethics and Organization StudiesVol. 9, No. 2.)
  20. Smith, R. (2003) Medical journals and pharmaceutical companies: uneasy bedfellows€ British Medical Journal 326: 1202-1205).
  21. Murthy, MB and Krishnamurthy, B. Indian J Pharmacol. Feb 2010; 42(1): 59-€“60.

 

 

Final White Paper on GMaP 27 April 2014.pdf Final White Paper on GMaP 27 April 2014.pdf
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