Requirements of Regulatory Guidelines in Pharma Marketing Nitesh Kumar*, Shakshi Tiwari, Prof.

Dr. B. P. Nagori, Mr. Akash Midha *Nitesh Kumar is presently pursuing M. Pharmacy in Pharmaceutical Management & Regulatory Affairs branch at Lachoo Memorial College of Science & Technology, Pharmacy Wing, Jodhpur, India. Sakshi Tiwari is presently pursuing M.

Pharmacy in Pharmaceutical Management & Regulatory Affairs branch at Lachoo Memorial College of Science & Technology, Pharmacy Wing, Jodhpur, India. Professor Dr. B. P.Nagori is Professor and Director at Lachoo Memorial College of Science & Technology, Jodhpur, India. Abstract: Recent article provide a nexus relationship between Health Care Professionals (HCP’s) and pharmaceutical companies. HCP’s are lured by promises of costly gifts and foreign trips for prescribing company products. This tends to arises a conflict between HCP’s interest in patient safety and personal gain.

Indian regulators effectively monitor the professional conducts of medicinal practitioner and pharmaceutical companies.The Department of Pharmaceuticals (DOP) under Ministry of chemicals and fertilizers, Government of India look after all activities of pharmaceutical industry and in order to check irregulatories the DOP introduced a voluntary draft uniform code of pharmaceutical marketing practices (UCPMP) for the Indian pharmaceutical industry in June 2011 which covers the area of claims and comparisons of medicinal product, advertisements, promotion etc. On the other hand Medical Council of India (MCI) amended its guidelines in 2009 to regulate the conduct of medical practitioner.These guidelines and code of marketing providing two tier approaches that covers HCP’s and pharmaceutical pharmaceutical companies operating in country. This presentation will highlight major loopholes in Pharma marketing regulations and discusses the requirement or strong Regulatory guidelines in Pharma marketing. Keywords Health Care Professionals, code of marketing, Pharma marketing regulations, Pharma marketing, medicinal practitioner and pharmaceutical companies IntroductionIndia has one of the fastest-growing pharmaceutical markets in the world, and its market size has pharmaceutical market is expected to reach US$20 billion by 2015 from US$11. 5 billion in 2009 at a CAGR of 11.

7%, and establish its presence it is the third-largest market in the world in terms of volume and 14th in terms of value. Pharmaceutical marketing, sometimes called medico-marketing or pharma marketing in some countries is the business of advertising or otherwise promoting the sale of pharmaceuticals or drugs. There is some evidence that marketing practices can negatively affect both patients and the health care profession.Many countries have measures in place to limit advertising by pharmaceutical companies. The relationship between medical practitioners and the pharma industry goes a long way back, since they are dependent on each other. What initially began as an information-sharing practice has evolved over a period of time into aggressive marketing strategies targeted at HCPs, to ensure greater coverage and translate into enhanced sales for pharma companies. The draft UCPMP for the Indian pharma industry aims to marketing their products to HCPs and their relationship with the latter.

The regulator intends to ensure that promotion of pharmaceuticals to health care professionals and interactions between pharma companies and the latter is carried out in a responsible, ethical, professional and legal manner. This will help to assure consumers that their choices in respect to their medication individual health care needs of patients. Key Characteristics of the Indian Pharma Sector: The Indian pharmaceutical market is marked by the following significant features: · Self-reliance displayed by the production of 70% of bulk drugs and almost the entire requirement of formulations within the country; · Low cost of production; Low R&D costs; · Innovative Scientific Manpower; · Excellent and world-class national laboratories specializing in process development and development of cost effective technologies; · Increasing balance of trade in pharma sector; · An efficient and cost effective source for procuring generic drugs especially the drugs going off patent in the next few years; · An excellent centre for clinical trials in view of the diversity in population.It was long believed that since doctors made the selection of drugs, mass marketing was a waste of resources; specific ads targeting the medical profession were thought to be cheaper and just as effective. This would involve ads in professional journals and visits by sales staff to doctor’s offices and hospitals. An important part of these efforts was marketing to medical students.

How are drugs promoted? Obviously firms who spend money need to recoup their costs. Furthermore industry analysts point out that Big Pharma under pressure. It needs to expand sales of blockbuster drugs since there are fewer drugs in pipeline.In order to sustain current levels of growth, firms would need to introduce one new product each year that would sell $4. 9 million for each 1 to 1. 5 per cent it has of the world pharmaceutical market. “A company the size of the newly merged Glaxo Wellcome/Smith KlineBeecham needs three to seven products each year, while one the size of Astra Zeneca needs two to four products each year. The problem is that research productivity is failing.

None of the major companies is close to the target. ” Depending on the category of drug the nature of the marketing mission is different.There are essentially two categories of drugs: self-medication or over the counter (OTC) drugs, and prescription drugs – sometimes referred to as ethical drugs. OTC drugs are promoted directly to consumers as well as physicians and other healthcare professionals and range from analgesics such as paracetamol to anti-histamines. Corstjens identifies four main buying parties for prescription drugs: 1. Prescriber – prescribing rights vary internationally and this category may include doctors, dentists, pharmacists, nurses and optometrists 2.Influencer – hospitals, nurses, professors, reimbursement agencies 3. Consumer – patient 4.

Financier – partly patient, partly government or third party (varies by country), managed health care organization (hospitals, Health Maintenance Organisations etc. ) The majority of Big Pharma’s marketing budget is targeted at doctors and others with prescribing power, who are effectively the gatekeepers to drug sales. In 2002 the Canadian Medical Association Journal estimated some US$19 billion is spent by Big Pharma annually in promoting drugs to doctors in the United States alone.

In the European Union only OTC drugs are promoted directly to consumers. Examples include analgesic preparations and some ailment-specific drugs such as the Schering Plough blockbuster Clarityn – a Hayfever remedy. In the United States all drugs may be promoted to consumers, but in practice direct to consumer advertising focuses on OTC and common-ailment targeted prescription drugs.

There are other more limited application drugs for less common diseases that are only promoted to health care professionals, and hospital and organizational formulary committees. Why should this we be concerned with this?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 • The risk of disease mongering • The increasing costs of drugs within national health systems • New drugs are the ones most heavily promoted and these are the ones with the least well-understood safety profiles. Drug promotion often misleading Much drug advertising is misleading. A U. S.

congressional inquiry reported that from August 1997 to August 2002 the FDA issued 88 letters accusing drug companies of advertising violations.In many cases companies overstated the effectiveness of the drug or minimised its risks. As discussed earlier the instance of non-compliance with medicines board’s requirements for accuracy is even higher in New Zealand. PHARMAC, the New Zealand government’s drug purchasing agency, has raised considerable concerns about the impact of DTCA saying that consumers interpret the existence of DTCA as government approval of advertised brands, which leads them to discount potentially important risk information. Doctors’ responses to Big Pharma promotionDoctors are obviously not undiscerning recipients of advertising and other forms of promotion. The easy dichotomy of pharmaceutical giants as villains and doctors as innocent victims is over-simplifying the situation. Clearly doctors need to use drugs in order to deliver their services, and it is also reasonable that firms should be allowed to promote their products.

But surely doctors should be looking also to independent sources of information, and how did we reach a point where so many doctors won’t attend an educational meeting unless it’s accompanied by free food and a bag of ‘goodies’.There was a strong correlation between doctors’ tendencies to recommend drugs and their receipt of gifts/sponsorship/ non-related payment etc. Studies show that gifts impacts on doctors’ prescribing practices. Wazana examined 29 empirical studies of the impact of interactions between the medical profession and Big Pharma.

Synthesising these findings certain negative outcomes were found to be associated with interactions with the industry: • Inability to identify inaccurate claims about medications • Rapid adoption and prescription of new drugs Formulary requests for medications without important advantages over existing listed medicines • Non-rational prescribing behaviours • Increased prescribing rates, and • Prescribing of fewer generics and more expensive new medications at no demonstrated advantage. In this industry, direct-to-consumer marketing is not popular, since patients rely on doctors’ prescriptions and guidance on any medication. Therefore, pharmaceutical companies focus more on promoting their products among HCPs. Marketing to health care providers takes four main forms: Gifting, Detailing, Drug samples, and Sponsoring. Regulation:The MCI initiated with a regulation related to the professional conduct, etiquette and ethics of registered medical practitioners in 2002.

This is called the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations. 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 nethical 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. Government regulation can be a highly effective strategy to alter professional behaviors. The mere threat of regulation can motivate changes in professional and industry behavior as seems to have occurred in recent years with scrutiny by the press and policymakers. Credible legal enforcement provides a strong incentive to comply with government regulation.Writing and enforcing regulations is not without challenge. Regulated parties often find loopholes in laws, challenge their validity, or simply flout them when enforcement is difficult. In addition, regulations can transform the prevailing perceptions of an issue from professional in nature to purely legal in nature, thereby replacing virtue with compliance.

Government regulations need to be carefully crafted to address the fundamental issue of influence while minimizing unintended consequences In addition to prohibiting small gifts and reminder items such as pens, notepads, staplers, clipboards, pill boxes, etc. the revised Code: Prohibits company sales representatives from providing restaurant meals to healthcare professionals outside their offices, but allows them to provide occasional meals in healthcare professionals’ offices in conjunction with informational presentations. That includes: 1. Prohibits company sales representatives from providing restaurant meals to healthcare professionals, but allows them to provide occasional meals in healthcare professionals’ offices in conjunction with informational presentations. 2.Includes new provisions requiring companies to ensure their representatives are sufficiently trained about applicable laws, regulations, and industry codes of practice and ethics. 3. Provides that each company will state its intentions to abide by the Code and that company CEOs and compliance officers will certify each year that they have processes in place to comply.

4. Includes more detailed standards regarding the independence of continuing medical education. 5.

Provides additional guidance and restrictions for speaking and consulting arrangements with healthcare professionals.Guidelines This is a voluntary code of Marketing Practices for Indian Pharmaceutical Industry , for the present and its implementation will be reviewed after a period of six months from the date of its coming into force and if it is found that it has not been implemented effectively by the Pharma Associations/Companies , the Government would consider making it a statutory code. 1. General Points * A medicinal product must not be promoted prior to receipt of the product authorization, authorizing its sale or supply.

The promotion of a medicinal product must be consistent with the terms of the product authorization. * Information about medicinal products must be up-to-date, verifiable and accurately reflect current knowledge or responsible opinion. * Information about medicinal products must be accurate, balanced, fair, objective, and must not mislead either directly or by implication. * Information must be capable of substantiation. 2. Textual and Audio-Visual Promotional Material All promotional material issued by a product authorisation holder or with his authority, must be consistent with the requirements of this Code.Where the purpose of promotional material is to provide persons qualified to prescribe or supply with sufficient information upon which to reach a decision for prescribing or for use, then the following minimum information, must be given clearly and legibly and must be an integral part of the advertisement: (i) The relevant product authorisation number and the name and address of the holder of the authorisation or the business name and address of the part of the business responsible for placing the medicinal product on the market; (ii) The name of the product, and a list of the active ingredients, using the common name, placed immediately adjacent to the most prominent display of the name of the product; (iii) Recommended dosage, method of use and, where not obvious, method of administration; (iv) Adverse reactions, warnings and precautions for use and relevant contraindications of the product; (v) A statement that additional information is available on request; (vi) The date on which the above particulars were generated or last updated. Promotional material must conform, both in text and illustration, to canons of good taste and must be expressed so as to recognize the professional standing of the recipients and not be likely to cause offence.

3. Samples Free samples of medicinal products shall not be supplied to any person who is not qualified to prescribe such product. Where samples of products are distributed by a medical representative, the sample must be handed directly to a person qualified to prescribe such product or to a person authorised to receive the sample on their behalf.The following conditions shall be observed in the provision of samples to a person qualified to prescribe such product: (i) Such samples are provided on an exceptional basis only (see (ii) to (vii) below) and for the purpose of acquiring experience in dealing with such a product (ii) Such sample packs shall be limited to prescribed dosages for three patients ; (iii) Any supply of such samples must be in response to a signed and dated request from the recipient; (iv) An adequate system of control and accountability must be maintained in respect of the supply of such samples; (v) Each sample pack shall not be larger than the smallest pack presented in the market; (vi) Each sample shall be marked “free medical sample – not for sale” or bear another legend of analogous meaning; (vii) Each sample shall be accompanied by a copy of the most up-to-date version of the Product Characteristics relating to that product.A person shall not supply a sample of a medicinal product which is an antidepressant, hypnotic, sedative or tranquillizer. The companies will maintain a detail record of free samples distributed to Healthcare practitioners. 4. Gifts No gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to persons qualified to prescribe or supply by a pharmaceutical company .

Gifts for the personal benefit of healthcare professionals (such as tickets to entertainment events) also are not be offered or provided. 5. Promotion of the medicinal product: A medicinal product cannot be promoted prior to the receipt of the product authorization which authorizes its sale or supply. When product uthorization has been obtained, promotion of such product has to be consistent with the terms of the product authorization. 6.

Information supplied about the medicinal product: Information supplied about the medicinal product must be accurate, balanced, fair, objective, up-to-date, verifiable, must accurately reflect current knowledge or responsible opinion and should not be misleading. Information so supplied must also be capable of substantiation, without delay, as and when requested by members of the medical and pharmacy professions. 7. Claims and Comparisons: Claims of the usefulness of a medicinal product must be based on an up-to-date evaluation. Further, certain restrictions have been placed on the use of the words “safe” and “new”.

The word “safe” must not be used without qualification and it must not be stated categorically that a medicine has no side effects, toxic hazards or risk of addiction. The word “new” must not be used to describe any medicinal product which has been generally available, or therapeutic indication which has been generally promoted, in India for more than twelve (12) months. With respect to product comparisons, they must be factual, fair and capable of substantiation and should not be misleading.

Further, brand names of products of other companies must not be used in comparison unless the prior consent of the companies concerned has been obtained. 8. Textual and Audio-Visual Promotional Material:All promotional material issued by a product authorization holder must be consistent with the requirements of the Uniform Code.

Certain details such as the active ingredients used in the medicinal product, recommended dosage, methods of use and administration, adverse reaction, warnings and precautions for use, to name a few, have to be mentioned clearly and legibly and must be an integral part of the advertisement. The IMC Regulations incorporates similar provisions that drugs prescribed by a physician or brought from the market for a patient should explicitly state the proprietary formulae as well as the generic name of the drug. 9. Medical Representatives:The Uniform Code has defined the term “medical representatives” to mean sales representatives, including personnel retained by way of contract with third parties, and any other company representatives who call on healthcare professionals, pharmacies, hospitals or other healthcare facilities in connection with the promotion of medicinal products. The Uniform Code has laid down that medical representatives have to adhere to the Uniform Code while promoting medicinal products.

Medical representatives have to, at all times, maintain a high standard of ethical conduct in the discharge of their duties. They must not employ any inducement or subterfuge to gain an interview and must not pay, under any guise, for access to a healthcare professional.Companies are responsible for the activities of all their employees and must ensure that employees who are concerned in any way with the drafting or approval of promotional material (including employees of third parties contracted on behalf of the company) are fully conversant and compliant with the requirements of the Uniform Code. Further, the Uniform Code states that other third parties working for or on ehalf of pharmaceutical companies (including advertising companies executives, business consultants and market research companies), and those that do not act on behalf of companies (such as joint ventures and licensees) commissioned to engage in activities covered by the Uniform Code, must have a good working knowledge of the Uniform Code. 0. Samples: The Uniform Code states that free samples of medicinal products cannot be supplied to any person who is not qualified to prescribe such product. The Uniform Code also lays down certain conditions that have to be observed while samples are being provided.

Further, supply of samples of a medicinal product which is an antidepressant, hypnotic, sedative or tranquillizer is not allowed. 11. Hospitality, Sponsorship and Meetings: The Uniform Code lays down certain guidelines that need to be followed by pharmaceutical companies with respect to the hosting and the sponsorship of educational events in relation to the pharmaceutical industry.Pharmaceutical companies may legitimately provide assistance that is directly related to the bona fide continuing education of healthcare professionals and which genuinely facilitates attendance of such healthcare professionals for the duration of the educational aspect of the event held in India. Further, the Uniform Code makes it explicitly clear that such meetings should not coincide with sporting, entertainment or other leisure events or activities. Likewise, the IMC Regulations provide that medical practitioners shall not accept any travel facility inside the country or outside, including rail, air, ship, cruise tickets, paid vacations from any pharmaceutical or allied healthcare industry or their representatives for self and family members for vacation or for attending conferences, seminars, workshops, continuing medical education programme as a delegate.

A medical practitioner should not accept individually any hospitality, like hotel accommodation for himself and family members, and shall not receive any cash or monetary grants from any pharmaceutical and allied healthcare industry for individual purpose in individual capacity, under any pretext. 12. Mode of Operation: All Indian Pharmaceutical Manufacture associations have to upload the Uniform Code, and a detailed procedure for lodging complaints, on their website. 13. Complaints / Breach: The Uniform Code lays down in detail how complaints received by pharmaceutical companies should be handled. It states that a complaint handling committee named “Committee for Pharma Marketing Practices” has to be present in all pharmaceutical companies / associations. Further, the procedure of lodging a complaint and the method of responding to complaints has also been provided in the Uniform Code.The committee has to consist of a panel of five (5) member companies, represented by the Executive head of such companies or a nominee not below the rank of Director in such company.

The Uniform Code also provides for a Review Committee which will consist of a panel of seven (7) member companies of the association. Based on the company involved, the Secretary General or the Chairman or the President of the Association as the case may be, will nominate five (5) members to the review committee, which must include three (3) complaint committee members who dealt with the complaint in the first instance. In case there has been a breach of the Uniform Code, which breach has been established, the Committee can: (i) Suspend or expel the company from the association; ii) Reprimand the company and publish details of the reprimand; or (iii) ask the company to take steps to recover items given in connection with the promotion of a medicine provided to health professionals and members of the public and the like; details of the action taken must be provided in writing to the committee which will be uploaded on the website of the association. Conclusion: Around 72% of the pharmaceutical companies study indicated that the code of marketing practice will impact the manner in which pharma products are marketed to consumers. The implementation of the uniform code of pharmaceutical marketing practices (UCPMP) would change the manner in which Pharma products are currently marketed in India.

According to the study, more than 50% of the companies in the UCPMP’s guidelines may lead to manipulation in recording of actual sampling activity also it indicated that the effectiveness of the code will be very low in the absence of legislative support provided to the UCPMP committee.In India Pharma companies in India should focus on building a robust internal controls system for ensuring compliance with the UCPMP also MCI was not stringently enforcing its medical ethics guidelines. Pharmaceutical companies and companies manufacturing and marketing medicinal products would do well to consider implementing strategies within their respective organizations addressing the requirements of the Uniform Code. Even though Uniform Code is a voluntary code currently, it is likely that its requirements will be mandatory in the near future; in any event, these requirements capture good corporate procedures and governance, and it is always advisable to follow such stipulations.Companies therefore need to analyze and evaluate measures to incorporate the Uniform Code into their various internal systems, including, employees’ and representatives’ codes of conduct and, indeed, their employment or consultancy agreements.

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