1. Regulatory Framework
1.1 Laws and Self-Regulatory Codes
The advertising of medicinal products is governed by a combination of legislation and self-regulatory 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 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 8.2, 2017) (the Pharmaceutical Code); and the IPHA Code of Standards of Advertising Practice for the Consumer Healthcare Industry (Revision 5.2, 2017) (the Consumer Code) (together the IPHA Codes). These IPHA Codes apply only to those pharmaceutical companies that have voluntarily agreed to be members of IPHA. The Irish Generics Medicines Association (IGMA), the industry body representing manufacturers of generic medicinal products, has published the Code of Practice on Advertising of Medicinal Products, 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 and Marketing Communications in Ireland (7th Edition) (ASAI Code), 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 Application and Legal Value of Regulatory Codes
The self-regulatory IPHA Codes listed above apply only to those pharmaceutical companies that have voluntarily agreed to be members of IPHA. They do not apply to healthcare professionals. The IPHA Codes fit into the framework established by Regulation 26 of the Regulations, which recognises the role of voluntary control of advertising of medicinal products. In general, the pharmaceutical industry usually looks to the IPHA Codes as best practice for advertising of medicinal products in Ireland.
The ASAI Code and General Commercial Communications Code apply to the advertising and broadcasting industries respectively. Industries that are involved in releasing marketing communications and sales promotions that promote the sale of medicinal products are bound by these codes. Again, neither of these codes apply to healthcare professionals.
2. Scope of Advertising and General Principles
2.1 Definition of Advertising
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.
2.2 Difference Between Information and Advertising
There is no definition of information as opposed to promotion in the applicable Irish legislation and codes of practice. The legitimate exchange of medical and scientific information to healthcare professionals is not prohibited, provided such information or activity does not constitute any form of promotion that would be prohibited under the Regulations.
Disease awareness campaigns are permitted to the extent that they do not in any way promote a brand of medicinal product, either directly by naming a product, or indirectly, for example:
- If there are non-prescription, as well as prescription-only, medicinal products 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 medicinal product. 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 medicinal product 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 medicinal product to help you," should be avoided.
2.3 Restrictions on Press Releases
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 medicinal products to the general public. However, information about a scientific discovery of a medicinal product 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.
Press releases with this 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. Therefore, press releases must include only factual and non-promotional information.
2.4 Comparative Advertising
Comparative advertising is governed by the Misleading Advertising Regulations and the CPA. Comparative advertising is permitted but there are restrictions on such advertising and instances where comparative advertising is not permitted. For instance, misleading comparative advertising is prohibited. In addition, comparative advertising must not discredit or denigrate the goods or services provided by a competitor. For instance, under the Pharmaceutical Code, the use of competitor 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.
3. Advertising for Unauthorised Medicines or Unauthorised Indications
3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications
The Regulations prohibit the 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 IPHA Codes also prohibit promotion of products prior to authorisation, subject to certain exceptions such as 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 it). However, the legitimate exchange of medical and scientific information to healthcare professionals is not prohibited, provided such information or activity does not constitute any form of promotion that would be prohibited under the Regulations.
Scientific, complete, objective, factual and non-promotional information concerning the off-label use of the products may be provided to healthcare professionals by representatives of the medical departments in response to an unsolicited request by the healthcare professional for such information.
In addition, correspondence to healthcare professionals in response to an unsolicited specific question about a particular medicinal product – which may include material of a non-promotional nature, and non-promotional, generic 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 prohibited.
3.2 Provision of Information During a Scientific Conference
Indications for unauthorised medicinal products and unauthorised indications in Ireland may be referenced in promotional material appearing on exhibition stands or distributed at international congresses or symposia held in Ireland, provided such medicinal products 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 or where the indication is not approved, no promotional material may be displayed or distributed, but legitimate, balanced and non-promotional scientific papers that include off-label information or information concerning unauthorised medicinal products may be provided at the medical booths at symposia or conferences in response to an unsolicited request from a healthcare professional for that specific information. Such information must not be distributed along with promotional materials or contain references to promotional materials. In addition, such information should not be distributed to patients or members of the general public.
3.3 Provision of Information to Healthcare Professionals
Marketing Authorisation Holders (MAHs) are not permitted to proactively distribute such information to healthcare professionals. As above, MAHs are only permitted to provide such information in response to an unsolicited request from the healthcare professional specifically requesting such information.
3.4 Provision of Information to Healthcare Institutions
The Pharmaceutical Code does not specifically exclude information on unauthorised medicines or unauthorised indications from the definition of promotion. Moreover, there is nothing to prohibit companies from providing non-promotional, generic information about companies, including financial data, descriptions of research and development programmes, and discussions of regulatory developments affecting the company and its products to healthcare institutions. The proactive provision of information on unauthorised medicines or unauthorised indications in the absence of a specific request by the institution could be deemed promotional, and therefore subject to the prohibition on the promotion of unapproved products.
4. Advertising to the General Public
4.1 Main Restrictions on Advertising to the General Public
The Regulations prohibit the advertisement of prescription-only medicinal products 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.
Advertising of non-prescription medicinal products to the general public is permitted subject to the requirements of the Regulations, the Consumer Code and the ASAI 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 Summary of Product Characteristics (SmPC), 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 self-diagnosis;
- 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 the opinions are genuine and made within the last three years).
Certain non-prescription medicinal products 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 and meet the requirements of the Misleading Advertising Regulations.
The ASAI Code also includes specific provisions in relation to the advertisement of medical products, including medicinal products. Those provisions largely reflect the requirements provided in the Regulations, the Pharmaceutical Code and the Consumer Code.
4.2 Information Contained in Advertising to the General Public
See 4.1 Main Restrictions on Advertising to the General Public for information requirements. There is no prohibition on the inclusion of pricing information.
4.3 Restrictions on Interactions Between Patients or Patient Organisations and Industry
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 directly or indirectly promoted through these groups.
It is permissible for a pharmaceutical company to donate to a patient organisation for general purposes, for a particular project or piece of research, sponsoring speakers for events or undertaking projects of joint interest. Each IPHA member company must make publicly available a list of patient organisations to which it provides financial support and/or significant indirect/non-financial support. 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. The compensation must be reasonable and not exceed the fair market value of services provided.
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.
4.4 Restrictions on Endorsements by Healthcare Professionals
Advertising of medicinal products to the public must not include endorsements by scientists, healthcare professionals or celebrities.
5. Advertising to Healthcare Professionals
5.1 Restrictions on Information Contained in Advertising Directed at 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 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. There is no requirement to include the price of the product nor is there any restriction on including this information.
5.2 Reference to Data Not Included in the Summary of Product Characteristics
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. The Pharmaceutical Code requires all promotional information to be consistent with the information in the SmPC. MAHs must therefore ensure that all information concerning studies not included in the SmPC is consistent with and does not contradict the information in the SmPC. 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.
5.3 Restrictions on Reprints of Journal Articles
The Pharmaceutical Code does not inhibit the exchange of medical and scientific information. The distribution of reprints of journal articles is permissible provided, however, certain requirements are met. For instance, journal articles that contain information on unlicensed products or unlicensed indications must not be proactively distributed to healthcare professionals. However, legitimate, balanced and non-promotional scientific papers that include off-label information or information concerning unauthorised medicinal products may be provided in response to an unsolicited request from a healthcare professional for that specific paper/journal. Such information must not be distributed along with promotional materials or contain references to promotional materials.
6. Vetting Requirements and Internal Verification Compliance
6.1 Requirements for Prior Notification/Authorisation
There is no necessity to have advertising pre-approved by a regulatory or industry authority. However, the Health Products Regulatory Authority (HPRA) reserves the right to pre-review advertisements.
6.2 Compliance with Rules on Medicinal Advertising
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.
The Pharmaceutical Code requires 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 the compliance with the Pharmaceutical Code.
There are no legal or code requirements for standard operating procedures (SOPs) governing advertising activities, although this would be considered best practice.
7.1 Regulation of Advertising on the Internet for Medicinal Products
The general rules relating to the advertising of medicinal products apply to the use of the internet and/or social media. Annex IV (Guidance on Digital Communication in the Pharmaceutical Sector) of the Pharmaceutical Code includes a specific section on the use of social media in the context of pharmaceutical advertising.
7.2 Advertising for Medicines on Social Media
Only non-prescription medicinal products can be advertised to the public, and this includes marketing that is conducted online or by post, telephone, e-mail or any other electronic communications. The rules discussed in 4 Advertising to the General Public apply to the use of social media in this regard.
Prescription medicinal products can be advertised through the internet, but only to individuals qualified to prescribe or supply them, and only with the individuals' prior consent. Restricted information should only be placed in a secure part of a website for registered users or subscribers only.
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 enquiries 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 enquiry or their nominee. It may be acceptable to contact patients through social media channels in certain circumstances (eg, 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.
7.3 Access Restrictions on Websites
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 enquiry or their nominee.
Restricted information should only be placed in a secure part of a website for registered users or subscribers only. Annex IV of the Pharmaceutical Code suggests that effective processes preventing access to others should be used at the entry point of website sections aimed at healthcare professionals. In certain circumstances, the use of a prominent disclaimer on the site to inform visitors that the site is suitable for healthcare professionals only and providing a hyperlink to a site appropriate to the general public may be possible. Caution should be exercised in relation to linking and reverse linking to sites, which may raise copyright issues or breach the Acceptable Use Policy of the relevant website. Companies should be careful not to target online advertisement to countries where the product in question may not have a MA.
Annex IV also advises that companies should have a clear policy in place regarding social media use by company employees. 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.
8. Inducement/Anti-Bribery General
8.1 General Anti-Bribery Rules
Irish legislation makes the active or passive bribery of a member, officer or servant of a public body a criminal offence. The principal statutory offence is contained within the Public Bodies Corrupt Practices Act 1889. Section 1 (2) of the Act states that it is an offence for any person alone, or in conjunction with others, to corruptly give, promise or offer any gift, or advantage whatsoever as an inducement to, or reward for, or otherwise on account of an officer holder or his special adviser or a director of, or occupier of a position of employment in a public body. A gift can take the form of money or property. Public bodies in Ireland include the Health Service Executive, which covers all publicly run hospitals within the state. Public bodies can also include any other body, organisation or group which is financed wholly or partly out of monies provided by the Irish government. As such, semi-private or private hospitals may also fall within the scope of the Act if those hospitals receive funding from the state.
The Prevention of Corruption Acts 1906 to 2010 and the Ethics Acts and the Civil Service Code of Standards and Behaviour are also relevant.
Holders of certain public positions (including senior personnel within the Health Service Executive (HSE), HPRA, the Department of Health and in voluntary hospitals) must disclose certain interests to the Standards in Public Office Commission. These include gifts and/or the provision of travel facilities, living accommodation, meals or entertainment valued at more than EUR650 in aggregate in any given year. While responsibility for compliance rests with the recipient of the gift, the provider of the gift can be requested to assist the Standards in Public Office Commission in its investigations, and failure to do so can be a criminal offence Moreover, the Regulations and the relevant self-regulatory codes of conduct contain provisions on interactions with and provision of benefits to healthcare professionals and organisations. Both the Regulations and the IPHA Codes prohibit the 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. These prohibitions are not specific to healthcare organisations. However the anti-bribery legislation above would apply to such organisations.
8.2 Legislative or Self-Regulatory Provisions
Please see 8.1 General Anti-Bribery Rules. The prohibition on benefits in the Regulations and the IPHA Codes 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.
9. Gifts, Hospitality, Congresses and Related Payments
9.1 Gifts to Healthcare Professionals
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. 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. There is no monetary limit on these.
9.2 Limitations on Providing Samples to Healthcare Professionals
The Regulations prescribe requirements in relation to the distribution of samples. 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). A maximum of six 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".
Under the Pharmaceutical Code, sampling shall not extend beyond two years after the samples were first requested for each particular new medicinal product. Additional strengths or different dosages cannot be considered as new medicinal products. 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 tranquillisers are prohibited, along with any controlled drug as defined in Section 2 of the Misuse of Drugs Act 1977, as amended. The Regulations also require the supplier of samples to maintain an adequate system of control and accountability.
9.3 Sponsorship of Scientific Meetings
Companies may legitimately provide assistance that is directly related to the bona fide continuing education of healthcare professionals and which genuinely facilitates attendance of the healthcare professional for the duration of the educational aspect of the event. Where appropriate and depending on the time, location and length of the meeting, support to healthcare professionals may cover actual travel expenses, meals, refreshments, accommodation and registration fees. Certain restrictions will apply. For instance:
- hospitality is permitted subject to restrictions, eg, 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 EUR80 per recipient. This threshold includes VAT but excludes any gratuity, and only applies to events held in Ireland;
- it should be the programme that attracts delegates and not the associated venue or hospitality;
- companies must not organise or sponsor meetings to coincide with sporting, entertainment or other leisure events or activities; and
- the event must be held at an appropriate venue that is conducive to the main purpose of the event.
Sponsorship of continuing medical education is permitted provided it is related to bona fide continuing education. Any support or financial assistance given must be "unrestricted," which means that the content must be developed independently of the pharmaceutical company's influence and not adversely affect the judgement of a medical practitioner
9.4 Sponsorship of Cultural, Sports or Other Non-scientific Events
Pharmaceutical companies are not permitted to sponsor, secure and/or organise, directly or indirectly, any entertainment, sporting or leisure events.
9.5 Grants or Donations to Healthcare Professionals or Healthcare Institutions
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 obliges companies to make publicly available information in relation to these donations, grants and sponsorship, and from 1 January 2016 companies were required to make public details of all "Transfers of Value" that occurred in 2015.
9.6 Restrictions on Rebates or Discounts to Healthcare Professionals or Healthcare Institutions
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.
9.7 Payment for Services Provided by Healthcare Professionals
Healthcare professionals can be used as consultants and advisers, whether in groups or individually, for:
- services (eg, chairing or speaking at meetings, being involved in medical/scientific studies or in clinical trials);
- participating in advisory board meetings; and
- participating in market research where such participation involves remuneration and/or travel.
The Pharmaceutical Code states that they are entitled to be remunerated for their time as long as there is a legitimate need for the services, a written contract is signed in advance, 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. Moreover, companies are 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.
9.8 Prior Authorisations or Notifications
There are no prior authorisations or requirements in relation to any of the activities above.
10.1 Requirement to Disclose Details of Transfers of Value
There is no requirement in the applicable Irish legislation for companies to make publicly available information about transfers of value provided by them to healthcare professionals, healthcare organisations or patient organisations.
The requirements for companies to make publicly available information about transfers of value is set out in the self-regulatory Pharmaceutical Code and are applicable only to members of IPHA or the European Federation of Pharmaceutical Industries and Associations (EFPIA). 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 medicinal products; (ii) are not listed in Article 4 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 was from 1 January 2015 and the information was made public from 1 July 2016. 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. 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 Article 5 of Annex V 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.
10.2 Foreign Companies and Companies That Do Not Yet Have Products on the Market
In relation to foreign companies, it will depend on the particular factual circumstances. For instance, the following scenarios may apply:
- foreign company makes a payment to an HCP, no presence in Ireland: no disclosure obligation;
- foreign company makes a payment to an HCP, presence through a local subsidiary that is a member of IPHA: disclosure obligation; and
- foreign company makes a payment to an HCP, presence through a local subsidiary that is NOT a member of IPHA: no disclosure obligation.
The disclosure requirements do not specifically exclude companies that do not yet have products on the market. The rules concern transfers of value provided to Irish healthcare professionals and organisations regardless of the marketing status of the product in Ireland.
11.1 Enforcement Bodies
The HPRA is the body responsible for monitoring the advertising of medicinal products and enforcing the Regulations. The Competition and Consumer Protection Commission is the regulatory body with oversight of general consumer law.
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.
On the self-regulatory side, IPHA regulates compliance with the IPHA Codes.
11.2 Initiating Proceedings for Advertising Infringements
Prosecutions may be brought by the HPRA, the Minister, the Pharmaceutical Society of Ireland and the HSE. A competitor may inform any of the above bodies of non-compliant advertising.
The HPRA can order the withdrawal of a misleading advertisement and the issuing of a corrective statement in respect of a published advertisement. Decisions of the HPRA may be appealed to the Irish courts. 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. A competitor may inform IPHA of non-compliant advertising provided they first make a reasonable effort to resolve differences with the competitor directly. 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.
General consumer law complaints may also be brought before the Competition and Consumer Protection Commission.
11.3 Penalties for Violating Advertising Rules and Rules on Inducements to Prescribe
Penalties for a breach of the Regulations range from a fine of up to EUR2,000 and/or imprisonment of up to 12 months on summary conviction; and to a fine of up to EUR120,000 and/or a term of imprisonment of up to ten years on indictment. On subsequent convictions, the maximum fine increases to EUR300,000. If an offence is committed by a body corporate, personal liability may apply to the officers.
Penalties for breach of the IPHA Codes 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 EUR3,000 and/or imprisonment not exceeding six months on summary conviction; a fine of up to EUR5,000 and/or imprisonment not exceeding 12 months for subsequent summary convictions; a fine of up to EUR60,000 and/or up to 18 months' imprisonment on a first conviction on indictment; a fine of up to EUR100,000 and/or up to 24 months' imprisonment for subsequent convictions on indictment; and a daily fine of up to EUR500 for each day that the contravention continues following summary conviction, with this daily fine rising to a maximum of EUR10,000 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.
11.4 Relationship Between Regulatory Authorities and Courts
The IPHA 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; however, IPHA may refer difficult or persistent breaches of the IPHA 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 any MAHs 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 IPHA Codes, the HPRA will either require that the advertisement be corrected or, less frequently, take legal proceedings.
11.5 Recent Enforcement Trends
As a result of the increased use of social media, we 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.
The HPRA is increasingly active and is pursuing more cases arising out of breaches of the Regulations each year. The HPRA has been increasingly monitoring advertising practices through social media.
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.