1 GENERAL – MEDICINAL PRODUCTS
1.1 What laws and codes of practice govern the advertising of medicinal products in Ireland?
The advertising of medicinal products is governed by a combination of legislation and codes of practice. The principal regulations are the Medicinal Products (Control of Advertising) Regulations 2007 (S.I. No. 541 of 2007) (the "Regulations"), which implement Titles VIII and VIIIa of Directive 2001/83/EC (as amended) (the "Directive"). In addition, general laws concerning advertising and commercial practices are set out in the Consumer Protection Act 2007 (the "CPA") and the European Communities (Misleading and Comparative Marketing Communications) Regulations 2007 (the "Misleading Advertising Regulations"). The Ethics in Public Office Acts, 1995 and 2001 (as amended) (the "Ethics Acts"), apply to promotional practices involving healthcare professionals who also hold certain designated public positions or directorships. The Prevention of Corruption Acts 1889 to 2010 and the Criminal Justice (Theft and Fraud Offences) Act 2001, as amended, also apply in circumstances where promotional practices are found to be corrupt. The Health Products Regulatory Authority (the "HPRA") is the body responsible for monitoring the advertising of medicinal products and enforcing the Regulations. The National Consumer Agency is the regulatory body with oversight of general consumer law, while the Broadcasting Authority of Ireland is the regulator for radio and television broadcasts in Ireland.
The law is supplemented by a number of codes of practice. The Irish Pharmaceutical Healthcare Association ("IPHA"), the industry body representing the international research-based pharmaceutical industry in Ireland, has published two relevant codes of practice: the IPHA Code of Practice for the Pharmaceutical Industry (Edition 8.1, 2015) (the "Pharmaceutical Code"); and the IPHA Code of Standards of Advertising Practice for the Consumer Healthcare Industry (Revision 5.1, 2010) (the "Consumer Code") (together the "Codes"). The Association of Pharmaceutical Manufacturers of Ireland ("APMI"), the industry body representing manufacturers of generic medicinal products, has published the APMI Code of Practice on Advertising of Medicinal Products (Edition 1, 2010), a similar code based on the Regulations and the Directive. The Advertising Standards Authority for Ireland ("ASAI"), the independent self-regulatory body for the advertising industry, has issued a "Code of Standards for Advertising, Promotional and Direct Marketing in Ireland" (6th Edition), which applies to advertising generally, while the Broadcasting Authority of Ireland has produced a "General Commercial Communications Code", which applies to advertising broadcasts on radio or television channels licensed in Ireland.
1.2 How is "advertising" defined?
"Advertising" is defined in the Regulations as any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products. This specifically includes: advertising to the general public and those who are qualified to prescribe or supply medicinal products; supply of samples; inducements to prescribe or supply by the gift, offer or promise of any benefit or bonus, in money or in kind; sponsorship of promotional meetings and scientific conferences attended by persons qualified to prescribe or supply; and, in particular, the payment of travelling and accommodation expenses associated with such conferences.
1.3 What arrangements are companies required to have in place to ensure compliance with the various laws and codes of practice on advertising, such as "sign off" of promotional copy requirements?
The Regulations require that a scientific service be established within the company to compile and collate all information relating to products. Medical sales representatives must be adequately trained and have sufficient scientific knowledge to enable them to provide information which is as precise and as complete as possible about the product they are promoting. Companies must keep available samples of all advertising emanating from their undertaking together with information indicating the persons to whom it was addressed, the method of dissemination and the date of first dissemination, and such information must be supplied to the HPRA upon request. The Codes require that the scientific service must include a doctor or, where appropriate, a pharmacist or other suitably qualified person who must approve all promotional material prior to release. Such person must certify that the advertisement complies with the Pharmaceutical Code and all applicable laws, is consistent with the relevant SmPC, and is a fair and truthful presentation of the facts concerning the medicinal product being promoted. The Pharmaceutical Code requires that each company appoint at least one senior employee who is responsible for supervising compliance with the Pharmaceutical Code.
1.4 Are there any legal or code requirements for companies to have specific standard operating procedures (SOPs) governing advertising activities? If so, what aspects should those SOPs cover?
There are no legal or code requirements for SOPs governing advertising activities.
1.5 Must advertising be approved in advance by a regulatory or industry authority before use? If so, what is the procedure for approval? Even if there is no requirement for prior approval in all cases, can the authorities require this in some circumstances?
There is no necessity to have advertising pre-approved. However, the HPRA reserves the right to pre-review advertisements.
1.6 If the authorities consider that an advertisement which has been issued is in breach of the law and/ or code of practice, do they have powers to stop the further publication of that advertisement? Can they insist on the issue of a corrective statement? Are there any rights of appeal?
The HPRA can order the withdrawal of a misleading advertisement and the issuing of a corrective statement in respect of a published advertisement. The Irish Courts can order the withdrawal of an advertisement and that a corrective statement be issued, where a party is convicted of a specified offence under the Irish Medicines Board Act 1995, as amended (the "IMB Act"), and the court is satisfied that the advertisement was misleading. IPHA may require the withdrawal of an advertisement if it is of the opinion that it is not in the interests of consumer safety. Decisions of the IPHA Code Council may be appealed to the IPHA Appeals Board, and the decision of the IPHA Appeals Board is final and binding. Decisions of the HPRA may be appealed to the Irish Courts.
1.7 What are the penalties for failing to comply with the rules governing the advertising of medicines? Who has responsibility for enforcement and how strictly are the rules enforced? Are there any important examples where action has been taken against pharmaceutical companies? To what extent may competitors take direct action through the courts?
Penalties for breach of the Regulations range from a fine of up to €2,000 and/or imprisonment of up to 12 months on summary conviction, to a fine of up to €120,000 and/or a term of imprisonment of up to 10 years on indictment. On subsequent convictions, the maximum fine increases to €300,000. If an offence is committed by a body corporate, personal liability may apply to the officers. Prosecutions may be brought by the HPRA, the Minister for Health (the "Minister"), the Pharmaceutical Society of Ireland and the Health Service Executive. A competitor may inform any of the above bodies of non-compliant advertising.
Penalties for breach of the Pharmaceutical Code are dealt with by the "Code Council" of IPHA and range from: an order to cease the breach; a reprimand; an order for the recovery of offending material; publication of a corrective statement; publication of the decision; referral of the matter to the Minister; and suspension or expulsion from IPHA. A competitor may inform IPHA of non-compliant advertising.
Penalties for breach of the Misleading Advertising Regulations and the CPA consist of a fine of up to €3,000 and/or imprisonment not exceeding six months on summary conviction, a fine of up to €5,000 and/or imprisonment not exceeding 12 months for subsequent summary convictions, a fine of up to €60,000 and/or up to 18 months' imprisonment on a first conviction on indictment, a fine of up to €100,000 and/or up to 24 months' imprisonment for subsequent convictions on indictment, and a daily fine of up to €500 for each day that the contravention continues following summary conviction, with this daily fine rising to a maximum of €10,000 for each day that the contravention continues following conviction on indictment. The Misleading Advertising Regulations and the CPA allow a competitor to apply to court for an order preventing a company from engaging in misleading marketing or prohibited comparative advertising.
1.8 What is the relationship between any self-regulatory process and the supervisory and enforcement function of the competent authorities? Can, and, in practice, do, the competent authorities investigate matters drawn to their attention that may constitute a breach of both the law and any relevant code and are already being assessed by any self-regulatory body? Do the authorities take up matters based on an adverse finding of any self-regulatory body?
The Codes fit into the framework established by Regulation 26 of the Regulations, which recognises the role of voluntary control of advertising of medicinal products. Breaches of the Pharmaceutical Code are generally dealt with by the Code Council (questions 1.6 and 1.7 above); however IPHA may refer difficult or persistent breaches of the Codes to the Minister. IPHA may also advise the ASAI of its findings against an advertiser and recommend action.
In addition, advertising is monitored and regulated by the HPRA. It supervises compliance with the Regulations by performing random reviews of advertisements in various media, including journal publications, newspapers, radio and television advertising. It may also carry out inspections at the offices of marketing authorisation holders (MAH) which advertise human medicinal products, and investigate complaints received in relation to advertisements. If such investigations show non-compliance with the Regulations and/ or the Codes, the HPRA will either require that the advertisement be corrected or, less frequently, take legal proceedings.
1.9 In addition to any action based specifically upon the rules relating to advertising, what actions, if any, can be taken on the basis of unfair competition? Who may bring such an action?
An individual/company who believes that a particular company is engaging in unfair competition (as prohibited by the Competition Act 2002 (as amended)) may bring an action for damages in the courts. Alternatively, it may report the behaviour to the Competition and Consumer Protection Commission, which may bring an action on its own behalf. An individual/company who believes that a company has breached its intellectual property may bring a matter to the courts under legislation such as the Trade Marks Act 1996 (as amended) or through a number of actions such as passing off. Recourse for defamation is available by taking an action under the Defamation Act 2009.
2 PROVIDING INFORMATION PRIOR TO AUTHORISATION OF MEDICINAL PRODUCT
2.1 To what extent is it possible to make information available to healthcare professionals about a medicine before that product is authorised? For example, may information on such medicines be discussed, or made available, at scientific meetings? Does it make a difference if the meeting is sponsored by the company responsible for the product? Is the position the same with regard to the provision of off-label information (i.e. information relating to indications and/or other product variants not authorised)?
The Regulations prohibit promotion of medicinal products that are not the subject of a marketing authorisation or a certificate of traditional use registration (the latter registration relates to herbal medicinal products). The Codes also prohibit promotion of products prior to authorisation, subject to certain exceptions for materials at international congresses and symposia held within Ireland. Separately, the CPA deems as a "prohibited commercial practice" a representation that a product has an authorisation which it does not have. Advertisements as part of a vaccination campaign, however, are approved (provided the Minister has permitted same). In addition, correspondence responding to a specific question about a particular medicinal product, which may include material of a non-promotional nature, and non-promotional, general information about companies, including financial data, descriptions of research and development programmes, and discussions of regulatory developments affecting the company and its products, are not subject to prohibition.
2.2 May information on unauthorised medicines and/ or off-label information be published? If so, in what circumstances?
Indications for unauthorised medicines and off-label usage in Ireland may be referenced in promotional material appearing on exhibition stands or distributed at international congresses or symposia held in Ireland, provided such medicines and indications are in fact approved in at least one other country in the EEA. This exception applies only to meetings that are truly international and scientific. A clearly visible and legible statement must also be included, indicating that the material relates to a product or indication that is unapproved in Ireland. In addition, where prescribing information is provided, an explanatory statement must also be included indicating that licensing conditions differ internationally. If products are not approved in the EEA, no promotional material may be displayed or distributed, but scientific papers may be provided.
2.3 Is it possible for companies to issue press releases about unauthorised medicines and/or off-label information? If so, what limitations apply?
The Regulations do not deal specifically with press releases. The Pharmaceutical Code, however, defines press releases as a form of promotion, and therefore the same requirements apply to press releases and media statements as any other promotional material. Nevertheless, the Pharmaceutical Code also indicates that information about a scientific discovery of a drug may be supplied where it is desirable or necessary to do so in the public interest. This may also apply where the object is to inform the public of scientific and medical progress, or where it is required or desirable to provide information to the public as shareholders or as persons with some other special or valid interest.
2.4 May such information be sent to healthcare professionals by the company? If so, must the healthcare professional request the information?
Correspondence in response to a specific question by a healthcare professional may be accompanied by non-promotional material; however, the provisions of the Regulations and the Codes do not apply to such communications.
2.5 How has the ECJ judgment in the Ludwigs case, Case C-143/06, permitting manufacturers of non-approved medicinal products (i.e. products without a marketing authorisation) to make available to pharmacists price lists for such products (for named-patient/ compassionate use purposes pursuant to Article 5 of the Directive), without this being treated as illegal advertising, been reflected in the legislation or practical guidance in Ireland?
Following the ECJ's decision in the Ludwigs case (Case C-143/06), the Medicinal Products (Control of Placing on the Market) Regulations 2007 were amended to provide that where products are made available pursuant to the compassionate use exemption, "no advertisement relating to the product, other than one that states only the trade name, pack size, price and dose" may be issued at the request or with the consent of the pharmacist, wholesaler or manufacturer, and the regulations are clear that no such advertisement or representation may be issued with a view to it being seen by the general public. As a consequence, authorised manufacturers are now permitted to provide pharmacists and wholesalers with information in respect of the trade name, pack size, price and dose quantity for such exempt medicinal products. Previously, an authorised manufacturer was prohibited from issuing any advertisement in respect of such products, whether by means of any catalogue, price list or circular.
2.6 May information on unauthorised medicines or indications be sent to institutions to enable them to plan ahead in their budgets for products to be authorised in the future?
As indicated above at question 2.4, responses to unsolicited requests for information are not covered by the Regulations or the Pharmaceutical Code. Nevertheless, the provision of such information in the absence of a request is likely to be deemed promotional, and therefore subject to the prohibition on the promotion of unapproved products.
2.7 Is it possible for companies to involve healthcare professionals in market research exercises concerning possible launch materials for medicinal products as yet unauthorised? If so, what limitations apply? Has any guideline been issued on market research of medicinal products?
Under the Pharmaceutical Code, market research cannot be used as a form of disguised promotion. Accordingly, market research activities that may be deemed disguised advertising would be prohibited on the basis of unapproved drug promotion. Certain guidance can be found in the Pharmaceutical Code, which states that methods used for market research must never discredit or reduce confidence in the industry. Research questions must not be phrased in order to solicit disparaging references to competitors or their products. Access to participants must not be gained by subterfuge and only minimal incentives can be given, which must be commensurate with the work involved.
3 ADVERTISEMENTS TO HEALTHCARE PROFESSIONALS
3.1 What information must appear in advertisements directed to healthcare professionals?
The Regulations require certain minimum information to be provided to healthcare professionals, including the product's name, a list of active ingredients using the common name placed immediately adjacent to the most prominent display of the product name, the classification for the sale or supply of the product, one or more of the product's indications and the method of administration where it is not obvious. A clear and legible statement of the information in the summary of product characteristics ("SmPC") regarding adverse reactions, precautions and contraindications, dosage and method of use relevant to the indications must be positioned within the advertisement so as to enable the reader to readily appreciate the relationship between this information and the claims and indications of the product. The name and address of the holder of the marketing authorisation, certification of registration or certificate of traditional use registration or the business name and address of the part of the business responsible for placing the medicinal product on the market should also be provided along with the authorisation number. If applicable, the words "traditional herbal medicinal product for use in", followed by one or more therapeutic-approved indications, and followed by the words "exclusively based upon long-standing use", should be included. Separate requirements exist for abbreviated reminder advertisements. The Pharmaceutical Code adds that this information should be clear, legible and an integral part of the promotional material.
3.2 Are there any restrictions on the information that may appear in an advertisement? May an advertisement refer to studies not mentioned in the SmPC?
In advertising to persons qualified to prescribe or supply, such an advertisement must contain the information set out in question 3.1 above.
The Pharmaceutical Code prohibits the making of exaggerated claims in advertising, as well as making disparaging references to other producers' products, services or promotions. The use of a rival producer's logos or brands is prohibited unless their consent has been received. It is prohibited to advertise a product as being "new" if it has been generally available in Ireland for more than 12 months. It is also prohibited under the Pharmaceutical Code to use the word "safe" in an advertisement without qualification. Comparisons with rival products must be factual, fair and capable of substantiation.
The Regulations are silent on the specific point of referring to studies which are not in the SmPC, except to say that information may not be included if it is not accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the product. It is also prohibited to include in written advertising any quotation, tables or other illustrative matter taken from a medical journal or other scientific work unless it is accurately reproduced and the precise sources of the information are indicated.
3.3 Are there any restrictions to the inclusion of endorsements by healthcare professionals in promotional materials?
Names and photographs of healthcare professionals must not be used without consent, or in a manner that would breach the ethical code of the appropriate profession. Testimonials do not constitute substantiation and the opinions expressed should be supported with independent evidence of their accuracy. Clinical and/or scientific opinions of healthcare professionals cannot be directly or implicitly disparaged. Quotations from medical literature or personal communications received from healthcare professionals must accurately reflect the meaning of the author and the significance of the study.
3.4 Is it a requirement that there be data from any, or a particular number of, "head to head" clinical trials before comparative claims may be made?
Both the Regulations and Pharmaceutical Code are mute on comparative claims in respect of "head to head" clinical trials. Nevertheless, the Pharmaceutical Code requires comparisons of medicinal products to be factual, fair and capable of substantiation. Comparisons must not mislead by distortion, undue emphasis, omission or in any other way.
3.5 What rules govern comparative advertisements? Is it possible to use another company's brand name as part of that comparison? Would it be possible to refer to a competitor's product which had not yet been authorised in Ireland?
From a general perspective, comparative advertising is permitted under the Trade Marks Act, 1996, provided it is in accordance with honest practices in industrial or commercial matters and does not take unfair advantage of, or is not detrimental to, the distinctive character or reputation of the trademark. Such advertising must also comply with Misleading Advertising Regulations and the CPA, which prohibits misleading comparative advertising. Under the Pharmaceutical Code, however, brand names cannot be used in comparator advertisements without the prior consent of the relevant brand owner. In addition, the products, services and promotions of other companies cannot be disparaged in advertising either directly or implicitly. Due to the prohibition on the promotion of unapproved medicines, unauthorised competitor products should not be referenced in promotional material. See also question 3.3 above.
3.6 What rules govern the distribution of scientific papers and/or proceedings of congresses to healthcare professionals?
The Pharmaceutical Code specifically states that its application is not intended to inhibit the exchange of medical and scientific information during the development of a preparation. The distribution of scientific papers at international congresses or symposia held in Ireland is permissible even where reference is made to medicines or indications that are unapproved in the country. See also question 2.1.
3.7 Are "teaser" advertisements permitted that alert a reader to the fact that information on something new will follow (without specifying the nature of what will follow)?
Neither the Regulations, nor the Pharmaceutical Code, deal specifically with "teaser" advertisements. Nonetheless, the applicable provisions of the Regulations and Pharmaceutical Code must be observed at all times in respect of the promotion of medicines.
4 GIFTS AND FINANCIAL INCENTIVES
4.1 Is it possible to provide healthcare professionals with samples of medicinal products? If so, what restrictions apply?
Free samples of medicinal products may only be supplied to persons who are qualified to prescribe such products, on an exceptional basis only and for the purpose of acquiring experience in dealing with the product. When distributed by medical representatives, they must be handed directly to the individual qualified to prescribe, or his agent. Samples may only be provided in response to a written request (signed and dated). Under the Pharmaceutical Code, a maximum of four samples, per year, per recipient, may be provided and only in the smallest presentation of the product on the market, marked "Free Medical Sample – Not for Sale". Sampling shall not extend beyond two years after the samples were first requested for each particular new medicine. Additional strengths or different dosages cannot be considered as new medicines. Each sample must be accompanied by the most up-to-date SmPC and, if sent by post, adequately packaged to be reasonably secure from the access of children. Free samples of anti-depressants, hypnotics, sedatives or tranquilisers are prohibited, along with any controlled drug as defined in section 2 of the Misuse of Drugs Act 1977, as amended. The supplier of samples must maintain an adequate system of control and accountability.
4.2 Is it possible to give gifts or donations of money to healthcare professionals? If so, what restrictions apply?
It is prohibited to supply, offer or promise gifts, pecuniary advantages or benefits in kind to healthcare professionals, in the course of promoting medicinal products. Healthcare professionals are also prohibited from accepting such items. From 1 July 2014, the limited exemptions that were previously in place have been abolished and a blanket prohibition on gifts comes into force. The prohibition does not apply to the transmission of information or educational materials or to items of medical utility which will be permitted in certain circumstances. The transmission of information or educational materials will be permitted, provided they are: i) inexpensive; ii) directly relevant to the practice of medicine or pharmacy; and iii) directly beneficial to the care of patients. Companies may provide items such as pens and paper pads exclusively during company organised meetings, as long as they are non-product branded and inexpensive. Items of medical utility aimed directly at the education of healthcare professionals and patient care may be provided if they are inexpensive and do not offset the cost of routine business practice of the recipient. These are not considered gifts.
4.3 Is it possible to give gifts or donations of money to healthcare organisations such as hospitals? Is it possible to donate equipment, or to fund the cost of medical or technical services (such as the cost of a nurse, or the cost of laboratory analyses)? If so, what restrictions would apply?
A pharmaceutical company may provide support in the form of educational, research or employment grants and the donation or sponsorship of medical equipment for the betterment of patients. Such support must be in response to a written request from the healthcare organisation or healthcare professional for a specific type of support that must be genuinely needed. While healthcare professionals may request the support provided, grants must be paid directly to the relevant healthcare organisation only and the support provided must be relevant to the practice of medicine or pharmacy and be intended for use solely in the organisation. The provision of any such support must not be conditional on the prescription, supply or use of the company's products or be linked in any way to promotion. The support must be modest, reasonable and in proportion to the scale and scope of the recipient institution. The Pharmaceutical Code also encourages companies to make publicly available information in relation to these donations, grants and sponsorship and from 1 January 2016, companies will be required to make public details of all "Transfers of Value" that occurred from 1 January 2015.
4.4 Is it possible to provide medical or educational goods and services to healthcare professionals that could lead to changes in prescribing patterns? For example, would there be any objection to the provision of such goods or services if they could lead either to the expansion of the market for, or an increased market share for, the products of the provider of the goods or services?
As per question 4.2 above, as of 1 July 2014, a blanket prohibition on gifts comes into effect. However, this prohibition does not apply to the transmission of information or educational materials or to items of medical utility which will be permitted in certain circumstances. The Pharmaceutical Code also prohibits the provision of support where it is linked in any way to product promotion.
4.5 Do the rules on advertising and inducements permit the offer of a volume-related discount to institutions purchasing medicinal products? If so, what types of arrangements are permitted?
The negotiation of price margins and discounts is allowed in the ordinary course of business. Any discounts must be clearly set out in the sales invoice.
4.6 Is it possible to offer to provide, or to pay for, additional medical or technical services or equipment where this is contingent on the purchase of medicinal products? If so, what conditions would need to be observed?
The Regulations do not allow "inducements" to increase sales of particular products. This example is likely to be considered an inducement and so would be contrary to the Regulations.
4.7 Is it possible to offer a refund scheme if the product does not work? If so, what conditions would need to be observed? Does it make a difference whether the product is a prescription-only medicine, or an over-the-counter medicine?
The Consumer Code prohibits offering a refund to a dissatisfied customer. The ASAI Code also provides that any marketing material for pharmaceutical products shall not offer refunds in similar situations.
4.8 May pharmaceutical companies sponsor continuing medical education? If so, what rules apply?
See question 4.3 above. Sponsorship of continuing medical education is permitted provided it is related to bona fide continuing education. Any support or financial assistance given must not adversely affect the judgment of a medical practitioner.
5 HOSPITALITY AND RELATED PAYMENTS
5.1 What rules govern the offering of hospitality to healthcare professionals? Does it make a difference if the hospitality offered to those healthcare professionals will take place in another country? Is there a threshold applicable to the costs of hospitality or meals provided to a healthcare professional?
Hospitality is permitted provided that the assistance provided is: related to bona fide continuing education and is objectively reasonable; secondary to the main purpose of the event taking place; does not exceed the level that recipients would normally pay for themselves; is not extended to spouses or other accompanying persons who would not qualify in their own right; and does not include sponsoring, securing and/or organising, directly or indirectly, any entertainment, sporting or leisure events. Support for smaller local clinical meetings must be in response to a formal written request, indicating the exact anticipated items of expenditure, and support must only be given for room hire, equipment hire, actual travel expenses of speakers, honorarium to speakers and/or modest meals and light refreshments. No one company should sponsor a series of such meetings. Sponsorship of larger meetings is permitted, but should not be undertaken by any one company to the exclusion of other available and willing sponsors. Unless there is a valid reason to do so, a pharmaceutical company may not organise an event that is to take place outside Ireland. A valid reason exists if the majority of the invitees are based abroad, or if the relevant resource or expertise is based abroad. The conditions relating to the provision of hospitality also apply to the provision of hospitality abroad. It is the programme that must attract the attendees and not the venue or the hospitality. International events should not coincide with major sporting events. Hospitality may be offered at sales promotion or other events for purely professional and scientific purposes, provided it is reasonable in level, strictly limited to the main purpose or scientific object of the event and is not extended to other persons.
Where pharmaceutical companies provide or offer meals to healthcare professionals, the value of each meal (including food and beverages) may not exceed the monetary threshold set by the Pharmaceutical Code, currently €80 per recipient. This threshold includes VAT but excludes any gratuity, and only applies to events held in Ireland. Hospitality occurring in another member state bound by the 2013 EFPIA Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations must comply with the hospitality threshold set in that member state.
5.2 Is it possible to pay for a healthcare professional in connection with attending a scientific meeting? If so, what may be paid for? Is it possible to pay for his expenses (travel, accommodation, enrolment fees)? Is it possible to pay him for his time?
It is not possible to compensate a healthcare professional for attending such a meeting. Depending on the time, location and length of the meeting, travel expenses, meals, refreshments, accommodation and registration fees may be covered.
5.3 To what extent will a pharmaceutical company be held responsible by the regulatory authorities for the contents of, and the hospitality arrangements for, scientific meetings, either meetings directly sponsored or organised by the company or independent meetings in respect of which a pharmaceutical company may provide sponsorship to individual healthcare professionals to attend?
This is not specifically dealt with in the Pharmaceutical Code, but it is foreseeable that the authorities would consider the pharmaceutical companies responsible in such a situation.
5.4 Is it possible to pay healthcare professionals to provide expert services (e.g. participating in advisory boards)? If so, what restrictions apply?
Healthcare professionals are permitted to partake in market research, medical/scientific studies and clinical trials. The Pharmaceutical Code states that they are entitled to be remunerated for their time as long as there was a legitimate need for the services, a written contract is signed in advance, specific criteria applied to the selection of the doctor, a reasonable number of doctors are retained, records of services are maintained, the engagement is not an inducement to prescribe and the compensation is reasonable and reflects the fair market value of the services provided.
Consultants are encouraged to disclose their relationships with companies when they write or speak in public. From 1 January 2016, companies will be required to make public details of all Transfers of Value that occurred from 1 January 2015. A further point to note in relation to consultants is that Transfers of Value relating to expenses agreed in the written agreement covering their activity will be disclosed as two separate amounts.
5.5 Is it possible to pay healthcare professionals to take part in post-marketing surveillance studies? What rules govern such studies?
Post-marketing surveillance studies must not be promotional or an inducement to prescribe, etc., and must be conducted with the main objective of developing science or education. Incentives given must be kept to a minimum and be commensurate with the work involved. Non-interventional studies must be conducted with a scientific purpose, according to a written study plan and in accordance with a written agreement, and any remuneration must be reasonable and reflect the fair market value of the work performed. The study should be approved by the company's scientific service and the results should be analysed, summarised and distributed, and records retained.
5.6 Is it possible to pay healthcare professionals to take part in market research involving promotional materials?
See question 5.4 above. Payment is possible in circumstances where the remuneration is reasonable and reflects the fair market value of the services provided. Access to respondents must not be gained by subterfuge and incentives should be kept to a minimum. Questions which would disparage competitors are to be avoided. Market research should not be disguised as sale promotion.
6 ADVERTISING TO THE GENERAL PUBLIC
6.1 Is it possible to advertise non-prescription medicines to the general public? If so, what restrictions apply?
Advertising of non-prescription medicines to the general public is permitted subject to the requirements of the Regulations and the Consumer Code. Before a medicinal product can be advertised, it must be the subject of a marketing authorisation or a certification of traditional use (in respect of herbal medicinal products). Such an advertisement must be accurate and present the product objectively and be consistent with the terms of the marketing authorisation and the SmPC of the product, and encourage rational use of the product. It must not contain material which:
- gives the impression that a medical consultation or surgical operation is unnecessary by offering treatment or diagnosis remotely;
- suggests that the effects of the medicinal product are guaranteed, are unaccompanied by adverse reactions or are better than, or equivalent to, those of another treatment or product;
- suggests that the product enhances health or is necessary for the health of the subject or that the health of the subject could be affected by not taking the product;
- leads the public to assume that the product has some special property or quality which is unknown or unrecognised;
- claims that the product will promote sexual virility or be effective in treating sexual weakness, etc. (unless authorised for such indication);
- is directed exclusively or principally at children or might result in harm to children or exploit their credulity;
- is endorsed by scientists, healthcare professionals or celebrities;
- suggests that the product is a foodstuff, cosmetic or other consumer product;
- suggests that the safety or efficacy of the product is due to the fact that it is natural;
- might, by the use of a case history, lead to erroneous selfdiagnosis;
- refers in improper, alarming or misleading terms to claims of recovery; and
- inappropriately uses pictorial representations of changes in the human body as a result of disease or injury or as a result of using the product.
The Regulations contain requirements as to the form and content of advertisements in that the product must be clearly identified as a medicinal product and include certain minimum information, such as the name of the product and instructions for use. The Consumer Code outlines further requirements, including that advertisements: must be accurate, truthful and easily intelligible; should not bring the industry into disrepute; should not offer treatment for a serious disease requiring intervention by a healthcare professional; should not offer to treat by correspondence, denigrate or unfairly attack other products; and should not exaggerate or influence consumers, or refer to a doctor or hospital tests or colleges or institutes (unless it can be substantiated) or use testimonials (unless genuine opinions and made within the last three years). Certain non-prescription medicines should not be promoted to the public, such as analgesics containing codeine, and special requirements apply when advertising antihistamines and/or sympathomimetics. The general provisions of the CPA regarding misleading commercial practices and prohibited commercial practices apply, prohibiting, for example, a representation that a product is able to cure an illness, dysfunction or malformation, if it cannot.
The Pharmaceutical Code also prohibits the making of exaggerated claims in advertising, as well as making disparaging references to other producers' products, services or promotions. The use of a rival producer's logos or brands is prohibited unless their consent has been received. It is prohibited to advertise a product as being "new" if it has been generally available in Ireland for more than 12 months. It is also prohibited to use the word "safe" in an advertisement without qualification. Comparisons with rival products must be factual, fair and capable of substantiation.
6.2 Is it possible to advertise prescription-only medicines to the general public? If so, what restrictions apply?
The Regulations prohibit the advertisement of prescription-only medicines or controlled drugs which are "directed wholly or mainly at members of the general public". This does not apply to the promotion of a vaccination campaign in respect of a vaccine or serum, provided the campaign is approved by the Minister. The BAI Code prohibits commercial communications specifically concerned with products available only on prescription.
6.3 If it is not possible to advertise prescription-only medicines to the general public, are disease awareness campaigns permitted encouraging those with a particular medical condition to consult their doctor, but mentioning no medicines? What restrictions apply?
Disease awareness campaigns are permitted to the extent that they do not in any way promote a brand of medicine, either directly by naming a product, or indirectly, for example:
- If there are non-prescription, as well as prescription-only, medicines available to treat a particular condition, advising patients to visit their doctor for treatment could be regarded as promoting the use of a prescription-only medicine. To avoid any such inference, the Pharmaceutical Code advises that consideration should be given to advising patients to talk to their doctor or pharmacist.
- In the case of a disease awareness campaign sponsored by a company which promotes the only available medicine for that disease/condition, particular care is required to ensure that the campaign could not be regarded as promoting that product. The Pharmaceutical Code notes that statements such as "Your doctor can prescribe a medicine to help you" should be avoided.
6.4 Is it possible to issue press releases concerning prescription-only medicines to non-scientific journals? If so, what conditions apply?
While not explicitly classified as "advertising" in the Regulations, press releases are expressly included in the definition of "promotion" in the Pharmaceutical Code. The Pharmaceutical Code prohibits the advertising or promotion of prescription-only medicines to the general public. Information about a scientific discovery of a medicinal product, however, may be supplied where it is desirable or necessary to do so in the public interest or where the object is to keep the public informed of scientific or medical progress. Information must be presented in a balanced way to avoid the risk of raising unfounded hopes in the public mind from the results of treatment. Statements must not be made to or designed for the purpose of encouraging members of the public to ask their doctor to prescribe a medicinal product.
6.5 What restrictions apply to describing products and research initiatives as background information in corporate brochures/Annual Reports?
The Pharmaceutical Code recognises that information about scientific discoveries and research initiatives may need to be disclosed to shareholders or others in the context of corporate brochures and Annual Reports.
6.6 What, if any, rules apply to meetings with, and the funding of, patient organisations?
Annex III of the Pharmaceutical Code contains guidelines for pharmaceutical companies on working with patient organisations. Pharmaceutical companies must ensure that the independence of patient organisations is respected and guaranteed. Medicinal products must not be promoted through these groups.
It is permissible for a pharmaceutical company to donate to a patient organisation either for general purposes, for a particular project or piece of research, sponsoring speakers for events or undertaking projects of joint interest. Each company must make publicly available a list of patient organisations to which it provides financial support and/or significant indirect/non-financial support. This should include a description of the nature of the support, including the monetary value of financial support and of invoiced costs. For significant non-financial support that cannot be assigned a meaningful monetary value, the description must describe clearly the non-monetary benefit that the patient association receives. This information may be provided on a national or European level and should be updated at least annually.
A pharmaceutical company may contract services from patient organisations, but only where such services are provided for the purpose of supporting healthcare or research. A written contract is required, which should include certain specified provisions, including a provision obliging the patient organisation to declare that it has provided paid services to the company whenever it writes or speaks in public about a matter that is the subject of the agreement or any other issue relating to that company, and a provision confirming that the extent of the service should not be greater than is reasonably necessary. The compensation must be reasonable and not exceed the fair market value of services provided. A company must make publicly available a list of patient organisations that it has engaged to provide significant contracted services and the total amount paid per patient organisation over the reporting period.
No one company should fund a patient organisation to the exclusion of other available and willing sponsors, except by the choice of the patient organisation, which is free to exercise its independence in determining who it wants to work with.
Any hospitality provided by a pharmaceutical company to patient organisations, and their members, should be reasonable, and secondary, to the main purpose of the event for which it is provided, and must not involve sponsoring or organising entertainment. Hospitality may only be extended to persons who qualify as participants in their own right, but in exceptional cases, may be provided to a bona fide 'carer' of a participant in the case of clear health needs.
Finally, pharmaceutical companies should not offer free samples to patient organisations.
7 TRANSPARENCY AND DISCLOSURE
7.1 Is there an obligation for companies to disclose details of ongoing and/or completed clinical trials? If so, is this obligation set out in the legislation or in a self-regulatory code of practice? What information should be disclosed, and when and how?
Other than the usual disclosure requirements with the various regulatory authorities, there is no requirement, legislative or otherwise, to publicly disclose details of ongoing or completed clinical trials.
7.2 Is there a requirement in the legislation for companies to make publicly available information about transfers of value provided by them to healthcare professionals, healthcare organisations or patient organisations? If so, what companies are affected, what information should be disclosed, from what date and how?
There is no requirement in legislation for companies to make publicly available information about transfers of value provided by them to healthcare professionals, healthcare organisations or patient organisations.
7.3 Is there a requirement in your self-regulatory code for companies to make publicly available information about transfers of value provided by them to healthcare professionals, healthcare organisations or patient organisations? If so, what companies are affected, what information should be disclosed, from what date and how? Are companies obliged to disclose via a central platform?
The requirements for companies to make publicly available information about transfers of value is set out in the Pharmaceutical Code. Pharmaceutical companies are required to disclose transfers of value made by them, whether directly or indirectly. This obligation does not extend to transfers of value that: i) are solely related to over-the-counter medicines; ii) are not listed in Article 3 of Annex V of the Pharmaceutical Code, including items of medical utility, meals and drinks, samples; or iii) are part of the ordinary course of purchases and sales of medical products by and between a pharmaceutical company and a healthcare professional or healthcare organisation.
Disclosures must be made from 1 January 2016 on an annual basis and each reporting period covers a full calendar year. The Pharmaceutical Code allows for disclosure by way of either (i) the company's website, or (ii) a central platform. The first reporting period will be from 1 January 2015. Disclosures must be made by pharmaceutical companies within six months after the end of the relevant reporting period, and the information disclosed must remain in the public domain for a minimum of three years after the time such information is first disclosed, unless the recipient's consent relating to a specific disclosure has been revoked. Disclosures must be made pursuant to the national code of the country where the recipient has its physical address. Pharmaceutical companies must document all transfers of value required to be disclosed and maintain the relevant records of the disclosures for a minimum of five years after the end of the relevant reporting period.
Except as expressly provided by the Pharmaceutical Code, transfers of value shall be disclosed on an individual basis. Pharmaceutical companies must disclose, on an individual basis for each clearly identifiable recipient, the amounts attributable to transfers of value to such recipient in each reporting period which can be reasonably allocated to one of the following categories.
In relation to transfers of value to a healthcare organisation, disclosure requirements are in respect of amounts related to: i) donations and grants; ii) contribution to costs related to events; or iii) fees for service and consultancy.
In relation to transfers of value to a healthcare professional, disclosure requirements are in respect of amounts related to: i) contribution to costs related to events; or ii) fees for service and consultancy.
Where a transfer of value, which would otherwise reasonably be allocated to one of the above categories, cannot be disclosed on an individual basis for valid legal reasons, a pharmaceutical company must disclose the amounts attributable to such transfers in each reporting period on an aggregate basis. A template form in respect of disclosure of Transfers of Value has been included at Section 5 of the Pharmaceutical Code. This form should be used for disclosures so as to ensure consistency and that the requirements of the Code are met.
The Pharmaceutical Code implements the EFPIA Disclosure Code without variation.
8 THE INTERNET
8.1 How is Internet advertising regulated? What rules apply? How successfully has this been controlled?
The scope of the Regulations extends to advertising on the internet, and the Pharmaceutical Code specifically includes the use of the internet as a means of promoting pharmaceutical products. Only non-prescription medicines can be advertised to the public through the internet, subject to certain restrictions, which are the same as those outlined above in question 6.1. Prescription medicines can be advertised through the internet to persons qualified to prescribe or supply them, but only with prior consent. Pharmaceutical companies should also be careful not to target online advertising to other countries where the relevant product does not have a marketing authorisation.
8.2 What, if any, level of website security is required to ensure that members of the general public do not have access to sites intended for healthcare professionals?
Restricted information should only be placed in a secure part of a website for registered users or subscribers only. A prominent disclaimer should be included on the website requiring users to confirm their status as a healthcare professional prior to accessing the full site and a hyperlink to an alternative website appropriate for the general public should also be included.
8.3 What rules apply to the content of independent websites that may be accessed by a link from a company-sponsored site? What rules apply to the reverse linking of independent websites to a company's website? Will the company be held responsible for the content of the independent site in either case?
Pharmaceutical companies should be aware that the linking and reverse linking to sites may not always be permissible, as it may raise copyright issues or breach the Acceptable Use Policy of the relevant website. It is therefore prudent to seek the consent of the relevant website owner in advance. A pharmaceutical company should include a disclaimer on its website to the effect that it has no control over and disclaims all liability for the accuracy of the content of the linked website, that it is not affiliated in any way with the site and that draws the user's attention to any Acceptable Use Policy or Terms and Conditions of the linked site.
8.4 What information may a pharmaceutical company place on its website that may be accessed by members of the public?
As the definition of advertising is very broad (see question 1.2 above), a pharmaceutical company should ensure that all information contained in a website complies with the requirements of the Regulations and with the Codes, paying particular attention to the differing rules applicable to prescription-only and non-prescription medicines.
8.5 Are there specific rules, laws or guidance controlling the use of social media by companies?
The general rules relating to the advertising of medicinal products apply to the use of the internet and/or social media. Only non-prescription medicines can be advertised to the public, and this includes marketing that is conducted online or by post, telephone, e-mail or other electronic communications. The advertisement must not give the impression that a medical consultation or surgical operation is unnecessary, particularly by offering a diagnosis or by suggesting treatment remotely. Prescription medicines can be advertised through the internet, but only to individuals qualified to prescribe or supply them, and only with the individual's prior consent. Restricted information should only be placed in a secure part of a website for registered users or subscribers only. The Pharmaceutical Code includes Annex IV (Guidance on Digital Communication in the Pharmaceutical Sector).
Annex IV advises that pharmaceutical companies should have a clear policy in place regarding social media use by company employees. It states that providing responses to inquiries received from healthcare professionals through digital channels is acceptable if performed in accordance with the Pharmaceutical Code. The use of electronic data communications for promotion is prohibited except with the prior permission, or upon the request, of the recipient. The responsibility rests with the company to ensure that receipt of the response is restricted to the healthcare professional making the inquiry or their nominee. It may be acceptable to contact patients through social media channels in certain circumstances (e.g. reminding them to regularly take their prescribed medication) if documented approval from both the healthcare professional and the patient is received and, in the example given, the message carries no purpose other than supporting patient compliance with the medication schedule instructed by the patient's healthcare professional.
Annex IV advises that it is a question of policy for a pharmaceutical company as to whether it is appropriate to correct erroneous entries on non-company mediated sites but cautions that care needs to be exercised since, if a company corrects certain information but omits to correct other information that may be perceived as related, such behaviour may be interpreted as a breach of the Pharmaceutical Code.
9 DEVELOPMENTS IN PHARMACEUTICAL ADVERTISING
9.1 What have been the significant developments in relation to the rules relating to pharmaceutical advertising in the last year?
Edition 8.1 of the IPHA Code of Practice for the Pharmaceutical Industry was published in January 2015 and amended certain provisions of Edition 8.0 of the Pharmaceutical Code. The revised Pharmaceutical Code provides for revisions relating to:
- The availability of information, i.e. – Healthcare Professionals ("HCPs") may be provided with items which are to be passed on to patients which may bear the name of a medicine and/or information about medicines only if such detail is relevant to the appropriate use of the medicine by patients who have been prescribed that medicine. Additionally, although items which are to be passed on to patients may not be issued at HCP exhibition stands, they may be exhibited and demonstrated on HCP stands and requests for them accepted for delivery at a later date. Patient support items (e.g. inhalation devices with no active ingredient) may be provided to HCPs during the course of a promotional call and medical sales representatives may deliver such items when requested by a HCP. In limited circumstances patient support items may be made available for the use by HCPs even though they are not to be passed on to patients. The purpose of this is to allow patients to gain experience in using their medicines whilst under the supervision of a HCP. Examples include inhalation devices (with no active ingredient) and devices intended to assist patients to learn how to self-inject.
- Branding – items of medical utility aimed directly at the education of HCPs and patient care may be provided if they are inexpensive and do not offset the cost of routine business practice of the recipient. Such items may branded with a company logo. In addition, it might also be acceptable to use the product branding when the item is used with that medicine, within the limits permitted by the relevant laws and regulations.
- Gifts – the qualifications on gifts have been abolished in so far as gifts, pecuniary advantages or benefits in kind in relation to the promotion/marketing of prescription medicines cannot be provided to persons qualified to prescribe or supply such prescription medicines.
9.2 Are any significant developments in the field of pharmaceutical advertising expected in the next year?
As a result of the increased use of social media, we would expect that future codes of practice will increasingly refer to promotion using this method. Social media is unlikely to be treated differently from any other advertising platform. Pharmaceutical companies will be required to regulate any discussion, user-generated content or endorsements posted on their social media page to ensure they comply with the relevant regulatory framework.
9.3 Are there any general practice or enforcement trends that have become apparent in Ireland over the last year or so?
The HPRA Enforcement Unit is increasingly active and is pursuing more cases arising out of breaches of the Regulations each year. The last year has seen a significant increase in instances where the HPRA Enforcement Unit has been involved in blocking the illegal import of counterfeit and prescription medicines purchased over the internet. The HPRA Enforcement Unit has worked closely with various customs and law enforcement agencies to combat these illegal activities and has frequently highlighted the dangers associated with the unregulated importation of medicines.
Originally published by Global Legal Group Ltd.
This article contains a general summary of developments and is not a complete or definitive statement of the law. Specific legal advice should be obtained where appropriate.