Survey report pharmaceutical marketing  ethical and responsible conduct
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An EY survey report among pharma marketeers post MCI era

An EY survey report among pharma marketeers post MCI era

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Survey report pharmaceutical marketing ethical and responsible conduct Document Transcript

  • 1. Pharmaceuticalmarketing: ethical andresponsible conductA survey on effectiveness of the guidelinesSeptember 2011
  • 2. 2 Pharmaceutical marketing: ethical and responsible conduct
  • 3. ForewordRecent media articles have brought to the fore the On the other hand, the Medical Council of India amendednexus between health care professionals (HCPs) and its guidelines in 2009 to regulate the conduct of medicalpharmaceutical companies. HCPs are lured by promises of practitioners, to keep pace with the changing medicalcostly gifts and foreign trips to exotic locales in the guise scenario in the country. It has introduced new regulationsof seminars and conferences in return for prescribing a with regard to the relationships of HCPs with pharmaceuticalcompany’s products. This tends to impair the judgment and allied health sector companies.g^ l`] @;H m] lg Y [gfÖa[l g^ afl]j]kl Z]lo]]f hYla]fl Along with these guidelines and code of marketing, Indiasafety and personal gain. Several other instances of has adopted a two-tier approach that covers HCPs (doctors)unethical behaviour on the part of HCPs and pharmaceutical and pharmaceutical companies operating in the country,companies frequently keep making the news. to create a transparent and ethical environment thatIndian regulators have been attempting to effectively oadd Z]f]Õl [gfkme]jk& @go]n]j$ ada_]fl Yf ]^^][lan]regulate and monitor the professional conduct of medical implementation of the regulations and periodicallypractitioners and pharmaceutical companies for a long monitoring them is imperative to ensure that the intent oftime. The Department of Pharmaceuticals (DoP) under the the legislation is interpreted uniformly and a level playingMinistry of Chemicals and Fertilizers, Government of India, Õ]d ak eYaflYaf] ^gj Ydd hdYq]jk&has been recently formed to look into the activities of the At Ernst & Young, we have conducted a survey amongpharmaceutical industry. In order to check any irregularities HCPs and pharmaceutical companies to understand theirthe DoP introduced a voluntary draft uniform code of perspective of the MCI’s guidelines and the DoP’s marketingpharmaceutical marketing practices (UCPMP) for the Indian [g]& O] Yj] hd]Yk] lg k`Yj] l`] Õfaf_k g^ gmj klmq oal`pharmaceutical industry in June 2011. Some of the areas you in this report.covered in the code include claims and comparisons ofmedicinal products, advertising and promotional material, We take this opportunity to express our gratitude to thethe activities and conduct of medical representatives as people and organizations who took time to respond to ourwell as the hospitality extended and gifts given to HCPs. kmjn]q& L`] j]hgjl Yf l`] Õfaf_k ogmd fgl `Yn] l`] kYe]Voluntary implementation of the UCPMP by pharmaceutical value without the support of these respondents and all thoseassociations and companies will be reviewed after six months who made the survey successful.from its initiation, and if it is discovered that it has not beeneffectively implemented, the Government may consider O] `gh] qgm Õf l`ak j]hgjl j]d]nYfl Yf afka_`l^md&making this a statutory code. Arpinder Singh Partner and National Director Fraud Investigation & Dispute Services (FIDS) Ernst & Young Pvt. Ltd. Pharmaceutical marketing: ethical and responsible conduct 3
  • 4. ContentsExecutive summary 5Marketing of pharmaceutical products 6Recordkeeping of samples and hospitality provided 8Impact on pharmaceutical sales 10Effectiveness of regulations 12Need for robust internal controls 14Annexure 16 4 Pharmaceutical marketing: ethical and responsible conduct
  • 5. Executive summaryThe ethical conduct of health care professionals is vital 2. Part two was conducted among health carefor maintaining professional autonomy, integrity and professionals on the guidelines issued by the Medicalindependence in their interactions with pharmaceutical Council of India (MCI) regarding its code of conduct forand allied health care organizations. Implementation of HCPs in their relationship with pharmaceutical and alliedgood marketing practices by pharmaceutical companies health care companies.demonstrates their adoption of ethical practices andtransparency in their operations.This survey is an attempt to provide an insight into how Methodologycurrent regulations are affecting health care professionalsand the pharmaceutical industry.  Ernst & Young was assisted by a market research agency in conducting interviews.The survey is in two parts:  All the interviews were conducted telephonically.1. Part one of the survey was conducted among marketing  In all, 100 respondents participated in the survey. professionals in the pharmaceutical sector on the draft uniform code of marketing practices for the Indian pharmaceutical industry (UCPMP) issued by the DoP, Ministry of Chemicals and Fertilizers, Government of India. Kge] g^ l`] ka_faÕ[Yfl Õfaf_k g^ l`] survey  Around two-third of the respondents felt that the implementation of the UCPMP would change the manner in which pharma products are currently marketed in India.  According to the survey, more than 50% of the respondents are of the opinion that the UCPMP’s guidelines may lead to manipulation in recording of actual sampling activity.  More than 50% of the respondents indicated that the effectiveness of the code will be very low in the absence of legislative support provided to the UCPMP committee.  An overwhelming majority of the respondents (90%) felt that pharma companies in India should focus on building a robust internal controls system for ensuring compliance with the UCPMP.  Around 72% of the respondents felt that the MCI was not stringently enforcing its medical ethics guidelines.  And only 36% of the respondents felt that the MCI’s guidelines would have an impact on the overall sales of pharma companies. Pharmaceutical marketing: ethical and responsible conduct 5
  • 6. Marketing of pharmaceutical products9[[gjaf_ lg l`] kmjn]q$ l`j]] gml g^ ]n]jq Õn]respondents indicated that the UCPMP issued by theDoP would impact marketing of drugs in India. 6 Pharmaceutical marketing: ethical and responsible conduct
  • 7. India has one of the fastest-growing pharmaceutical In 2002, over 20,000 registered drugmarkets in the world, and its market size has manufacturers sold US$9 billion worth off]Yjdq gmZd] af l`] hYkl Õn] q]Yjk& L`] [gmfljqÌk formulations and bulk drugs in India. However, mostpharmaceutical market is expected to reach of the players in the market are small to mediumUS$20 billion by 2015 from US$11.5 billion in 2009 enterprises and 250 of the largest companiesat a CAGR of 11.7%, and establish its presence control 70% of the Indian market.2Yegf_ l`] ogjdÌk d]Yaf_ )( eYjc]lk& 9l hj]k]fl$it is the third-largest market in the world in terms ofvolume and 14th in terms of value.1 Around 72% of theStatistics clearly indicate the tremendous growth potential of respondents indicated that theIndia’s pharmaceutical sector and the degree of competitionamong players to secure a larger share of the market. In this code of marketing practice willindustry, direct-to-consumer marketing is not popular, sincepatients rely on doctors’ prescriptions and guidance on any impact the manner in whichmedication. Therefore, pharmaceutical companies focusmore on promoting their products among HCPs. In sucha scenario, this takes three main forms — such companies pharma products are marketedgiving gifts and free drug samples, and their sponsoringcontinuing medical education (CME) for doctors. to consumers.The DoP released a draft uniform code on voluntaryregulation of the marketing practices3 in the Indian Figure 2:pharma industry on 2 June 2011. The regulator intends to Will UCPMP guidelines on claims and comparisons, and textual andensure that promotion of pharmaceuticals to health care audio-visual promotional material result in more transparent andprofessionals and interactions between pharma companies ethical marketing of pharma products in India?and the latter is carried out in a responsible, ethical, Noprofessional and legal manner. This will help to assure 28%consumers that their choices in respect to their medicationYj] eY] gf l`] ZYkak g^ l`] ]^Õ[Y[q g^ ]Y[` hjgm[l ^gj l`]individual health care needs of patients. YesFigure 1: 72%Will implementation of the UCPMP change the manner in whichpharma products are currently marketed in India? No Sample: 50 | Base: All 34% According to the code, pharma companies will be required to disclose relevant information on indications for use, known side effects and contra-indications of drugs for patients, to Yes enable them to make informed decisions on their choice 66% of medication. Furthermore, misrepresentation of existing products as new ones by simply changing their packaging will not be possible under the provisions of the code.Sample: 50 | Base: All1 Taking wings, Ernst & Young, 2009; “Indian pharma market valued at over Rs 55K crore in FY10,” The Economic Times, 30 July 2009.2 “Pharmaceuticals in India,” wikipedia, http://en.wikipedia.org/wiki/Pharmaceuticals_in_India, accessed 1 September 2011.3 www.pharmaceuticals.gov.in/uniformcode.pdf Pharmaceutical marketing: ethical and responsible conduct 7
  • 8. Record-keepingof samples andhospitality providedDrug samples distributed by drug companies to medicalpractitioners form an essential part of their overallmarketing strategy. According to the survey, more than 50%of the respondents felt that enforcement of UCPMP maylead to manipulation in recording actual sampling activity. 8 Pharmaceutical marketing: ethical and responsible conduct
  • 9. L`] j][gj%c]]haf_ j]imaj]e]flk ]Õf] af l`] [g]$relating to distribution of free samples, is expected to bringtransparency on the number of units sampled, the names More than 80% of theof medical representatives, as well as the place, quantityYf Yl] g^ kYehdaf_$ Yf Ydkg a]fla^q l`] Z]f]Õ[aYja]k g^ respondents felt that thethe free samples. This will help to curb unethical practicesin the guise of sampling. Furthermore, it will also help to words “reasonable” andidentify whether organizations are complying with the otherprovisions of the code. “appropriate” in the codeFigure 3:In light of UCPMP regulations relating to distribution of free are open to interpretatione]a[afYd kYehd]k$ ogmd Õ]d ^gjeYlagfk afmd_] af eYfahmdYlagf g^records to conceal non-compliance with the code? by pharma companies. No 46% Figure 4: What is the possibility that lack of explicit monetary limits set in the UCPMP in respect to guidelines on “reasonable hospitality,” as well as on “appropriate travel expenses, meals, refreshments, accommo- Yes dation and registrations,” etc., for HCPs will be open to interpreta- 54% tion by pharma companies? Very low 10% Very highSample: 50 | Base: All 32% Low 8%Af l`] YZk]f[] g^ Yfq [d]Yj aj][lan]k gj imYflaÕ[Ylagf ^gjextending hospitability to HCPs, it appears that the regulator Highmay have left a gap for pharma companies to take undue 50%advantage of the code. Sample: 50 | Base: All Pharmaceutical marketing: ethical and responsible conduct 9
  • 10. Impact on pharmaceutical salesNearly two-third of the medical practitioners whohYjla[ahYl] af l`] kmjn]q ^]dl l`Yl l`] E;AÌk _ma]daf]k oaddhave no impact on the sales of pharmaceutical companies. 10 Pharmaceutical marketing: ethical and responsible conduct
  • 11. More than three-fourth of theFigure 5: respondents, out of thoseDo you think the MCI’s guidelines, issued on 10 December 2009 inrespect to the interactions of practicing physicians with pharmaceuti-cal companies, will have an impact on the overall sales of pharma- who indicated that sales willceutical companies? be affected, felt that the extent of this effect would be Yes No 36% more than 6%. 64% Figure 6: To what extent will the sales of pharmaceutical companies be affected by MCI’s guidelines?Sample: 50 | Base: All >6% of total sales 78%E;A [g] g^ e]a[Yd ]l`a[k ^gj @;Hk gÌk Yf gfÌlk No gifts, travel facilities or hospitality to be accepted 4% to 6% of total sales 17% from pharmaceutical and allied health care organizations No cash or monetary grants accepted in individual 1% to 3% of total sales 6% capacity Ensure that medical research conducted is accurate and ethical <1% of total sales 0% Maintain professional autonomy Base: 18, All who agreed that MCI guidelines will impact the sales of No public endorsement of drug/ industry products pharmaceutical companiesMedical Council of IndiaThe MCI was established in 1934 under the Indian Medical Council Act, 1933. Its main function is establishing uniformklYfYjk g^ `a_` imYdaÕ[Ylagfk af e]a[af] Yf j][g_faraf_ e]a[Yd imYdaÕ[Ylagfk af AfaY Yf YZjgY& >Y[] Zq l`]challenges posed by the speedy development and progress of medical education in the country, the old Act was repealed in)1-. Yf Y f]o gf] ]fY[l]& L`ak oYk ^mjl`]j egaÕ] af )1.,$ )11+ Yf *(()&The MCI initiated with a regulation related to the professional conduct, etiquette and ethics of registered medical practitionersin 2002. This is called the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002.*In 2009, these regulations were further amended with the aim to achieve the following: Build a healthy relationship, based on self-regulation, between doctors and the pharmaceutical and allied health care sector, and prevent the unscrupulous practices of some doctors Enhance transparency in sales promotions, ban bribes paid to doctors for drug promotions and control other unethical practices Stop medical professionals from accepting gifts or perquisites such as free holidays from drug manufacturers and ensure that they prescribe drugs by their generic rather than their brand names*Source: http://www.mciindia.org/RulesandRegulations/CodeofMedicalEthicsRegulations2002.aspx Pharmaceutical marketing: ethical and responsible conduct 11
  • 12. Effectiveness of the regulationsEgj] l`Yf -( g^ l`] j]khgf]flk ^]dl l`Yl l`] E;AÌk_ma]daf]k ^gj e]a[Yd hjY[lalagf]jk Yf l`] <gHÌk [g] g^eYjc]laf_ hjY[la[]k ^gj h`YjeY [gehYfa]k oadd fgl km^Õ[]to ensure ethical marketing of drugs in India. 12 Pharmaceutical marketing: ethical and responsible conduct
  • 13. Figure 7: L`] [g] g^ eYjc]laf_ hjY[la[]k ]Õf]k l`] kl]hk ^gjIs the two-tier approach of MCIs regulating HCPs and the DoP in the forming a committee to handle complaints. However, moreMinistry of Chemicals and Fertilizers to regulate the pharma industrythe best way of deterring the practice of pharma companies luring than 50% of the respondents felt that in the absence ofHCPs through gifts and free hospitality offers? legislative support to this committee, the effectiveness of the code will be negligible or nil. Figure 9: In the absence of legislative support, how effective will the “Committee for Pharma Marketing Practices” be in acting on Yes complaints pertaining to non-compliance with the UCPMP? No 44% 56% Not effective Very effective 26% 6%Sample: 50 | Base: All Less effective 28% Effective 40%Nearly three-fourth of the respondents have highlightedinadequate enforcement of these guidelines. Therefore, it Sample: 50 | Base: Allmay take some time before the unethical drug promotionpractices of some medical practitioners and pharmacompanies are stopped.Figure 8: According to 72% of the@Yk l`]j] Z]]f ka_faÕ[Yfl ]f^gj[]e]fl g^ l`]k] _ma]daf]k Zqthe MCI? respondents, there has not Z]]f ka_faÕ[Yfl ]f^gj[]e]fl Yes 28% of the MCI’s guidelines. Ng 72%KYehd]2 -( t :Yk]2 9dd Pharmaceutical marketing: ethical and responsible conduct 13
  • 14. Need for robust internal controlsAccording to the survey,90% of the respondents feltthat pharma companies need morerobust internal controls to ensure theircompliance with regulations. 14 Pharmaceutical marketing: ethical and responsible conduct
  • 15. Figure 10: Kh][aÕ[ j]_mdYlagfk af l`] Ye]f] E;A _ma]daf]k$With the implementation of the UCPMP in the country, do you feelthat pharma companies should focus on building a robust internal prohibiting such practices, have therefore been put intocontrol system that relates to compliance with the DoP’s guidelines? practice. However, our survey respondents felt that the MCI has not been effective in implementing these regulations. No The draft UCPMP for the Indian pharma industry aims to 10% kh][aÕ[Yddq j]_mdYl] hjY[la[]k j]dYl] lg h`YjeY [gehYfa]k marketing their products to HCPs and their relationship with the latter. Yes 90% The Government will continue to introduce new regulations to monitor the relationship between health care professionals and the pharma industry. Pharma companiesSample: 50 | Base: All will need to demonstrate their compliance with these regulations and be transparent in their interactions with `]Ydl` [Yj] hjg^]kkagfYdk& L`]q [Yf Y[`a]n] l`ak ZqThe relationship between medical practitioners and putting in place an effective internal compliance reviewthe pharma industry goes a long way back, since they are program (CRP).dependent on each other. What initially began asan information-sharing practice has evolved over a periodof time into aggressive marketing strategies targetedat HCPs, to ensure greater coverage and translate intoenhanced sales for pharma companies. Consequently,practices such as giving gifts and other incentives to HCPshave crept into the system. This has raised serious concernsrelating to the professional autonomy and integrity of HCPsaccepting such enticements and their duty and responsibilityto their patients. Some of the essential characteristics of a CRP:  Assess existing processes and controls on activities covered by the code  Design guidelines or frame SOPs and templates to implement practices laid down in the code  Implement guidelines and establish independent approvers for transactions with respect to the code  Conduct periodic testing and monitoring of transactions to assess their compliance with the code  Review and improve practices for effective compliance  Impart training to target audience for effective implementation of SOPs and guidelines Pharmaceutical marketing: ethical and responsible conduct 15
  • 16. AnnexureHjgÕd] g^ j]khgf]flkFigure A: Figure B:Total no. of respondents - 100 Total no. of respondents from pharmaceutical companies - 50 BrandPharma managersprofessionals 6%50% Health care professionals Marketing 50% Others professional 20% 58% Product manager 16%References www.pharmaceuticals.gov.in/uniformcode.pdf http://www.mciindia.org/RulesandRegulationsCodeofMedicalEthicsRegulations2002.aspx 16 Pharmaceutical marketing: ethical and responsible conduct
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  • 18. More ways to stay connected to Ernst & YoungServices for you... Assurance, Tax, Transactions, Advisory O] hjgna] k]jna[]k lg `]dh qgm j]lYaf [gfÕ]f[] of investors, manage your risk, strengthen your control and achieve your potential. Read more on www.ey.com/Services Sector knowledge Center of excellence for key sectors We have specialized teams that bring sector knowledge to you. Read more on www.ey.com/industriesSubscribe to our... Publications — easy to use subscription form www.ey.com/subscription-form Webcasts and podcasts http://webcast.ey.com/thoughtcenter/ The choice is yours! Go to www.ey.com/india @Yn] im]klagfk YZgml Y kh][aÕ[ =Q k]jna[]7 Whatever your inquiry, we’ll help direct you to the right place. www.ey.com
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  • 20. Ernst & Young Pvt. Ltd.Assurance | Tax | Transactions | AdvisoryAbout Ernst & YoungErnst & Young is a global leader in assurance, tax, transaction and advisory services.Worldwide, our 141,000 people are united by our shared values and an unwaveringcommitment to quality. We make a difference by helping our people, our clients and ourwider communities achieve their potential.Ernst & Young refers to the global organization of member firms of Ernst & Young GlobalLimited, each of which is a separate legal entity. Ernst & Young Global Limited, a UKcompany limited by guarantee, does not provide services to clients. For more informationabout our organization, please visit www.ey.com.9Zgml =jfkl  Qgmf_Ìk >jYm Afn]kla_Ylagf  <akhml] K]jna[]kDealing with complex issues of fraud, regulatory compliance and business disputes candetract from efforts to achieve your company’s potential. Better management of fraudrisk and compliance exposure is a critical business priority – no matter the industrysector. Our more than 1,000 fraud investigation and dispute professionals around theworld bring the analytical and technical skills needed to quickly and effectively conductfinancial investigations, quantify economic damages and gather and analyze electronicevidence. Working closely with you and your legal advisors, we assemble the rightmultidisciplinary and culturally aligned team, and bring an objective approach and freshperspective to these sensitive and contentious situations – wherever you are in theworld. And because we understand that, to achieve your potential, you need a tailoredservice as much as consistent methodologies, we work to give you the benefit of ourbroad sector experience, our deep subject matter knowledge and the latest insights fromour work worldwide. It’s how Ernst & Young makes a difference.Ernst & Young Pvt. Ltd. is one of the Indian client serving member firms of EYGM Limited. For more information aboutour organization, please visit www.ey.com/indiaErnst & Young Pvt. Ltd. is a company registered under the Companies Act, 1956 having its registered office at 22Camac Street, 3rd Floor, Block C, Kolkata - 700016© 2011 Ernst & Young Pvt. Ltd. Published in India.All Rights Reserved.This publication contains information in summary form and is therefore intended for general guidance only. It is notintended to be a substitute for detailed research or the exercise of professional judgment. Neither EYGM Limited norany other member of the global Ernst & Young organization can accept any responsibility for loss occasioned to anyperson acting or refraining from action as a result of any material in this publication. On any specific matter, referenceshould be made to the appropriate advisor. In line with Ernst & Young’s commitment to minimize its impact on the environment, this document has 50% been printed on paper with a high recycled content.www.ey.com/indiaEYIN1109-097.