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Direct to consumer advertising of prescription drugs on internet: A Boon or a Curse

By Sushant Arora, Partner, Mumbai Office

Promoting products directly to consumers by the use of popular media. Historically, advertisers have used the traditional mass media - radio, television, newspapers, magazines, and billboards- to send their messages. But these are largely being replaced by Internet advertising. In today's world, advertising has a profound impact on the society of which consumer is a part. It is a powerful force that shapes the attitudes and behavior of the people. As advertising gives high returns in terms of money, pharmaceutical companies are spending more on medical drug advertising than on research and drug development.

Prescription drugs are the drugs which are required to be dispensed under the supervision of a physician. On the other hand, over the counter drugs can be sold directly to the consumers / patients without any doctor's prescription. The traditional pharmaceutical media for exposing and raising the product message of prescription drugs are professional journals, magazines or newspapers, direct mail, convention or hospital displays and service items such as educational films, medical illustrations and photographs, office supplies, text books, exhibitions and the like. For years pharmaceutical companies did most of their prescription drug marketing only to physicians, either through their sales force or by advertising in medical journals. However, in 1997 the Food and Drug Administration (FDA) issued new guidelines making it easier for pharmaceutical companies to advertise prescription drugs on television, print media as well as on the Internet. With the change in guidelines, the promotion of prescription only medicines using direct to consumer advertising is increasingly being used by the pharmaceutical industry as a means of enhancing market share. Brand name of prescription drugs such as Prozre, Viagra and Claritin have become as well known to consumers as brands of soft drinks.

The pharmaceutical companies note that the increased spending on medicine advertising on Internet is a boon. It has helped to educate consumers about their options and has caused people to see doctors about medications who might not have done so otherwise. It is thought to be source of quality patient information. DTCA can act as a tool to launch health communication and make an informed treatment choice. However, a number of physicians, consumer and health care groups have expressed concern over the increase in drug advertisement for several reasons. A major concern of these groups is whether advertisements on Internet are accurate, fair, balanced, truthful and whether these inform consumers of all the risks associated with taking the drug. According to them prescription drug advertising on Internet is a curse. It promotes inappropriate use of prescription drugs, or diverts consumers from better alternatives. It can cause damage by instigating rapid, widespread stimulation of use of new drugs before harmful effects are fully known. Advertisements exaggerate treatment benefits and use emotive messages to target people with milder health problems, many of whom are unlikely to benefit from the drugs advertised. Another concern over the increase in prescription advertisement is that the advertisement of medicines on Internet is driving up costs of health care. It is argued that advertising is expensive thus adding to the costs of medicine and that it also encourages consumers to request the higher cost brand name rather than less expensive generic alternatives. Further, advertising leads to higher medicine costs and overall health care costs through substitution of new, expensive drugs without treatment advantages. Many experts feel that drug companies should pay attention to the concerns being raised over their rapid increase in advertising expenditure. However, most drug companies say that they have no plans to cut back on their direct to consumer advertising costs as they need to educate consumers regarding their products.

Due to these burning issues, advertising of prescription drugs is currently allowed only in the USA and New Zealand. The European Parliament has emphatically opposed advertising to patients in line with the “precautionary principle”.

In India, direct to consumer (DTC) promotion is mainly in the sphere of social marketing i.e. on family planning initiatives, health awareness, hygiene and disease awareness. DTC product promotion is permitted for Ayurvedic proprietary medicines and for homeopathy drugs. DTC product promotion is prohibited for Schedule H and Schedule X drugs. Manufacturers cannot advertise prescription only drugs directly to the public because of their toxicity and the potential for harm from medically unnecessary or inappropriate use. It is prohibited as a health protection measure. However, this scenario is changing with the trends of an open society, liberal attitudes, fast access to world class information through the telecom - internet revolution, greater patient empowerment, and integration of Indian medical sector with the global market. Due to free access to Internet, the Indian population is being increasingly exposed to advertising for prescription drugs also. DTCA of prescription drugs still persists despite legal prohibitions.

Recent reports implicate that if properly used, DTCA of prescription drugs can lead to early diagnosis, better therapy and improved patient compliance in the acute phase as well as in the continuation phase of the treatment. So there is need to maximize the informational benefits of such advertising while minimizing potential misleading or confusing messages that could be contained in such advertising. Therefore, as a health protection measure, health care providers (including doctors, nurses, pharmacists etc.) should be made aware of the health care information that is being disseminated to their patients through Internet advertising. Increased awareness about information provided in advertisements might not only equip health care providers to better answer patients’ queries about advertising of medicines but also increase their awareness of any false and/or misleading claims in advertisements on internet to which their patients may be exposed. There is need to inculcate the art of critical appraisal amongst medical practitioners as well as patients. A multi prong strategy involving government, pharmaceutical industry, doctors, medical associations and consumers is urgently required.

 

What is drug promotion?

WHO defines drug promotion as ‘all informational and persuasive activities by manufacturers and distributors to induce/influence the sale and use of medicinal drugs.’[1] Drug promotion has an important bearing on the rational use of drugs; on drug price-control mechanisms, the manufacture, availability and use of essential drugs, on equity of drug distribution and the cost of health care—all making it a central public health issue. Thousands of Indian companies produce 70,000 brands of various drug formulations compared to WHO’s list of 250 essential drugs. Drugs are sold through chemists and stockists who make a margin on the sale. The private sector represents 80% of the health expenditure, so a doctor in private practice is an influential prescriber.

In India apart from registered medical practitioners, un- registered medical practitioners, i.e. "quacks" play an active role in health care system. In this situation pharmaceutical promotion can influence not only the use of a product, but also play an active role in our benefit of use of medicines.. In India, like other countries, the promotional information of prescription drugs and drugs sold without prescription (OTC-Drugs) is regulated by national legislation. Code of Ethics for Advertisement of Drugs, is a guideline to regulate the promotion of prescription drugs as well as OTC drugs marketed in India.

Considering the socio-economic condition in our country there is no way to avoid the situation of self-medication which is now an important element in Indian health care systems. Pharmaceutical information is of persuasive value which induces consumers to purchase drugs. Consumers, Naïve and uneducated consumers fall easy victims to unethical drug promotion practices.

A health professional obtains information from commercial sources of different pharmaceutical manufacturers through their sales professionals. Most of the time, pharmaceutical manufacturers claim that their newly introduced formulation is superior in respect of therapeutic efficacy to the existing formulation. Sales professionals produce their promotional documents and distribute the free samples along with eye catching visual-aids to target the increase of sales. The health professionals are initiated by such misleading documents and information to prescribe the product without justifying their claims.

In our country, we can take the example of the "Baby Oil" controversy of one multinational company and two big companies in Maharashtra. Finally, the drug authorities and the manufacturer settled the matter by deleting the word ``baby''. In fact, advertisements commonly contain misleading and inaccurate information in case of OTC drugs.

In a literature search on promotional practices undertaken by the Forum for Medical Ethics Society(FEMS), promotional practices have been grouped under three categories: information, incentives and trading practices.
Information
Doctors in developed countries have relatively better access to objective sources of information to offset what the industry promotes. There is not much documentation on drug information given to doctors in India. Most of the Indian articles deal with the accuracy of product information as given by medical representatives, package inserts and advertisements in medical journals. Drug advertisements in Indian medical journals contain less information on safety and clinical pharmacology than their American and British counterparts do.

Gifts and incentives

Studies suggest that doctors hold a range of views about gifts. However, smaller gifts and those useful in helping patients are more acceptable. Doctors readily accept gifts that are smaller and socially more acceptable. But they have double standards, and would frown if a politician accepted a similar gift. There was also a sense of ‘unique invulnerability’, that only ‘other’ doctors are influenced by gifts. Gifts from modest product samples to exotic cruises turn out to be a good investment for the companies, which spend huge amount of money because they are assured of returns. However, patients disapprove of gifts other than samples.

Trading practices

Internationally, it is well known that pharmaceutical firms have aggressive promotional tactics, but such practices have not been documented within the Indian subcontinent, either from the point of view of the strategies or the ethics of drug promotion. For example, people often get medications directly from chemists and retailers, bypassing doctors altogether, and drug companies exploit this link. The initial findings of the study seem to suggest that the doctor’s prescription is not so powerful, after all, in the Indian drug market.

In India, at the moment only the Magic Remedies (Objectionable Advertisement) Act[5], 1954 deals with misleading promotion. It has only one relevant clause, Clause 4, on misleading advertisements which: directly or indirectly gives false impression regarding the true character of the drug; makes a false claim for the drug, or is otherwise false or misleading in any particular material.

Where there is an irrational drug, then there is bound to be unethical promotion. Therefore, the codes which deal with the promotion of drugs need to be looked into:

  • International Federation of Pharmaceutical Manufacturers(IFPMA) code of Pharmaceutical Marketing Practices- updated in 1994
  • Criteria for medicinal drug promotion-prepared by World Health Organisation (WHO) in 1988 Guidelines on IFPMA Code of Pharmaceutical Marketing Practices-prepared by OPPI.
  • International Code on Pharmaceuticals-prepared by Health Action International (HAI)

 

The definition of 'promotion' is vital. WHO has stated, 'In this context, promotion refers to all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs.'

OPPI has ignored advertising through the electronic media, gifts, literature or display materials given to wholesalers and chemists, the sponsoring of individuals to attend meetings/ conferences, etc.

The WHO criteria states that training must include updated and continuing training. The training should also include ethical conduct including training on codes. Also, medical representatives should not offer inducements to prescribers and dispensers, and prescribers and dispensers should not solicit such inducements.

The code of conduct restricts many activities including those prescribed by legislation. Following steps can be brought to ethical code of advertisement and promotion of drugs:-

  • Prescription medicine i.e., "Schedule-H drugs" cannot be promoted to the general public.
  • Manufacturer or traders cannot promote their product for indication that are not listed in the approved product information.
  • Pharmaceutical representative or sales personal cannot promote the product over telephone unless the promotional material is marked urgent attention.
  • Unsolicited reprint of journal articles must be consistent with the product information and the word "safe" cannot be used unless it is substantiated.

    On an analysis of the various laws applicable to the promotion of drugs and the current situation prevailing, It can be concluded that the same is inadequate to deal with the maladministration of drugs which is taking place in India and only a thorough review of the same can help in countering this growing threat which is seemingly getting out of proportion.

The promotion of any irrational drug combination is bound to be unethical. It is also unethical to promote an irrational claim. The need of determining an ethical code of promotion of medicine is important. The following codes were available for study:

  • IFPMA code of Pharmaceutical Marketing Practices- updated in 1994
  • Criteria for medicinal drug promotion-prepared by WHO in 1988
  • Guidelines on IFPMA Code of Pharmaceutical Marketing Practices-prepared by OPPI, downloaded from their web page in August 2003
  • International Code on Pharmaceuticals-prepared by Health Action International (HAI)

This is an attempt to compare different codes towards developing a suitable code for India.

Objectives of the codes
The IFPMA code says, 'The international pharmaceutical industry is committed to the improvement of the health of the mankind through research and development of new medicines and production and marketing of pharmaceutical products of reliable quality, in accordance with internationally defined standards of good practice.'
What is a new medicine? Many new drugs do not have any significant advantage over existing drugs. Many are produced with mere molecular manipulation to overcome a competitive edge and medicines with the same effect are sold at higher prices.

The WHO code states: 'The main objective of ethical criteria for medicinal drug promotion is to support and encourage the improvement of health care through the rational use of medicinal drugs.' The ethical criteria start from the validity of the drug itself: is the drug or combination of drugs rational?
Today another important question is that of the price of medicines. In this context, the HAI code is explicit: 'The aim of this code is to enable consumers, particularly those from the developing countries, to procure safe and effective pharmaceuticals essential to their real health needs, at a cost they can afford.'
Another question arising from IFPMA's code is that of 'internationally defined standards of good practice'. Is it possible to have such a standard when so many codes exist, all for voluntary implementation?

Applicability of the codes
While IFPMA confines the applicability of its code to its member organisations and affiliates in the industry, WHO expanded its scope to people in all walks of life:  governments; the pharmaceutical industry (manufac-turers and distributors); the promotion industry (adver-tising agencies, market research organisations and the like); health personnel involved in the prescription, dispensing, supply and distribution of drugs; universities and other teaching institutions; professional associations; patients and consumer groups; and the professional and general media (including publishers and editors of medical journals and related publications). This definition of applicability is widest of all the codes. However, as things stand, it is a futile statement and does not enable corrective measures for violation of the code.

Scope of the Code
The IFPMA code states that promotional activities within the scope of the code include direct to-consumer advertising, where this is permitted under local laws. In many Third World countries, no regulatory law for promotion of medicines exists. What will be the responsibility of the industry and who will monitor them?
The HAI code defines the scope in different sectors such as drug registration; registration of new drugs; pre-registration clinical trials of new drugs; provision of information; labelling; package inserts and promotional materials; sales promotion of pharmaceutical products; pricing; sales and distribution; pharmaceutical technology; and research and development. The HAI code also explains and defines each of these sectors. In the absence of such definitions, the scope of the Code become futile-a problem evident in several clauses of the IFPMA code.
Definition of promotion in the codes
The definition of 'promotion' is vital. WHO has stated, 'In this context, promotion refers to all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs.'
For some reason the IFPMA code did not feel the need to provide such a definition. It states: 'Promotional materials for pharmaceutical products should be accurate, fair and objective and presented in such a way as to conform not only to legal requirements but also to high ethical standards and to be in good taste.' This statement is vague.
OPPI guideline have been more specific regarding promotion, defining it as: 'Promotional material on pharmaceutical products: printed literature (package inserts, data sheets, detail/visual aids, flip-charts, leave-behinds, mailings and advertisements); audio-visuals; sponsored symposia/conferences/guest lectures; gift items; information through medical representative training.'
However, OPPI has ignored advertising through the electronic media, gifts, literature or display materials given to wholesalers and chemists, the sponsoring of individuals to attend meetings/conferences, etc.
WHO has also defined 11 specific criteria for advertisements. OPPI mentions some four criteria and the IFPMA code mentions three. IFPMA categorises advertisements as 'all advertisements' and 'full advertisements'. Its code states that contraindications, side-effects and precautions must be mentioned only in 'full advertisements'. The HAI code defines advertisements as: 'Any representation conveyed by any means whatever for the purpose of promoting, directly or indirectly, the distribution or sale of any drug.'

Medical representatives
The IFPMA code mentions that medical representatives must be trained with sufficient medical and technical knowledge. They should also collect information from professionals about the use of a product.
The WHO criteria state that training must include updated and continuing training. The training should also include ethical conduct including training on codes. Also, medical representatives should not offer inducements to prescribers and dispensers, and prescribers and dispensers should not solicit such inducements.
The OPPI guidelines in this respect are:
Adequate training should include information on basic medical sciences such as anatomy, physiology, microbiology and pharmacology.
Sufficient medical knowledge should be given regarding aetiopathology and clinical aspects of the disease for which the product is used.
The representatives should be properly trained to impart information in an accurate and scientific manner. There is no reference to the appropriate conduct of a medical representative (MR). The company may refuse to take responsibility for the claims or quality of the campaign made by an MR.
The HAI code adds an important element by stating that the number of MRs 'must not exceed one representative per promoted pharmaceutical product per 500 registered physicians or other prescribers.' With the large product ranges of companies in India, this number would become outrageous. The number of MRs in each company must be restricted but so should the frequency of visits. The IFPMA only states that 'the frequency of printed material to healthcare professionals should be reasonable.'

Distribution of free samples
The OPPI remains quiet in this respect. The IFPMA states that 'samples may be given to prescribing professionals to familiarise them with the products, enable them to gain experience with the products in their practice, or on request.' WHO guidelines are more lenient, considering that free samples may be used by the weaker sections of society. However, in India, samples of old drugs are regularly distributed in large quantities. In some instances sale packs are also used as samples and these packs do not even contain the words 'free sample'. There is no regulation on the giving of samples. Some companies use the strategy of providing samples proportionate to the product's sales. This may lead to violation of ethics since samples should not be considered saleable.

Symposia and scientific meetings
The WHO code acknowledges the need for such meetings to be sponsored by manufacturers and distributors, and permits the giving of gifts or hospitality but they should be 'secondary'. The code states that 'any support to individual participants should not be conditional upon any obligation to promote any medical product.' This is absurd because obligation is implicit in such a relationship. Why else should a company sponsor individuals?
The IFPMA code states: 'payment of reasonable honoraria and reimbursement of out-of-pocket expenses, including travel, for speakers/prescribers are customary and proper,' but 'companies should not pay travel costs of persons accompanying invited members of the medical and allied professionals.'
In India, virtually no professional meetings are possible without the sponsorship of drug companies. In most of these meetings the main events are sparsely attended but the funfair sponsored by drug companies are always crowded. There is no limit to the money spent here and no sign of modesty. Companies compete with each other to sponsor in more and more exotic ways.

Gifts
Gifts found in professionals' offices vary from trifles to expensive items, and most are unrelated to their work. Quoting the IFPMA code, OPPI states: 'Promotional items of insignificant value, provided free of charge, are permissible as long as they are related to the healthcare provider's work and/or entail a benefit to patients.' Gift items should bear the brand names of the product and the generic name, only if possible. The value of the gift should not be so high as to oblige doctors to prescribe.
Though simple gifts may not directly influence prescription practices, they would not be distributed unless they had some related impact. It has been pointed out that a policy of limiting gift size is unlikely to eliminate bias, because 'even small gifts can subtly bias how arguments are evaluated, they can be surprisingly influential.'
Other issues
The IFPMA code does not provide guidelines on pre-registration of a drug which is left to the regulation of the respective countries. Similarly, there is no mention of the procedure to be followed in post-marketing surveillance. However, WHO discusses both these issues.
As the WHO code dates back to 1988, it has not addressed problems related to advertising in the electronic media. The IFPMA code deals with both the electronic media and advertisements on the Internet, but is vague and has nothing to say on web pages created by drug companies.
The IFPMA has many details on complaints regarding the code's violation but global experience shows that few complaints have been entertained and there is almost no redressal.

Regulations in India
The less said about this the better. We have a Magic Remedies (Objectionable Advertisement) Act, 1954. It has only one relevant clause, Clause 4, on misleading advertisements which: directly or indirectly gives false impression regarding the true character of the drug; makes a false claim for the drug, or is otherwise false or misleading in any particular material. After almost 50 years, surely it is time to develop a code on pharmaceutical promotional practices that is suitable for India, and the appropriate legislation to enforce it.