Faus & Moliner participates in the International Comparative Legal Guide to Pharmaceutical Advertising 2015

The International Comparative Legal Guide on advertising of medicinal products has been designed in order to provide international practitioners and in-house counsel with a comprehensive worldwide legal analysis of the laws and regulations on pharmaceutical advertising.

The guide includes a chapter for each major jurisdiction, in a practical Questions & Answers format that provides a broad overview of common issues in pharmaceutical advertising laws and regulations. All chapters are written by leading lawyers in the pharmaceutical sector.

Faus & Moliner lawyers, Jordi Faus and Rodrigo Osorio, were invited to participate in this project and they have written the Chapter dealing with Spain.

In their Chapter, Jordi Faus and Rodrigo Osorio answer, among others, the following questions:

General Issues

• What laws and codes of practice govern the advertising of medicinal products in Spain?
• How is “advertising” defined?
• 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?
• Are there any legal or code requirements for companies to have specific standard operating procedures (SOPs) governing advertising activities?
• Must advertising be approved in advance by a regulatory or industry authority before use?
• If the authorities consider that an advertisement which has been issued is in breach of the law and/or Code of Conduct, do they have powers to stop the further publication of that advertisement?
• What are the penalties for failing to comply with the rules governing the advertising of medicines?
• What is the relationship between any self regulatory process and the supervisory and enforcement function of the competent authorities?
• 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?

Providing Information Prior to Authorisation of Medicinal Product

• To what extent is it possible to make information available to health professionals about a medicine before that product is authorised?
• May information on unauthorised medicines be published? If so, in what circumstances?
• Is it possible for companies to issue press releases about medicinal products which are not yet authorised?
• May such information be sent to health professionals by the company?
• May information be sent to institutions to enable them to plan ahead in their budgets for products to be authorised in the future?
• Is it possible for companies to involve health professionals in market research exercises concerning possible launch materials for medicinal products as yet unauthorised?

Advertisements to Health Professionals

• What information must appear in advertisements directed to health professionals?
• Are there any restrictions on the information that may appear in an advertisement?
• Are there any restrictions to the inclusion of endorsements by healthcare professionals in promotional materials?
• Is it a requirement that there be data from any or a particular number of “head to head” clinical trials before comparative claims are made?
• What rules govern comparative advertisements?
• What rules govern the distribution of scientific papers and/or proceedings of congresses to doctors?
• 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)?

Gifts and Financial Incentives

• Is it possible to provide health professionals with samples of products? If so, what restrictions apply?
• Is it possible to give gifts or donations of money to medical practitioners?
• Is it possible to give gifts or donations of money to institutions such as hospitals?
• Is it possible to provide medical or educational goods and services to doctors that could lead to changes in prescribing patterns?
• Do the rules on advertising and inducements permit the offer of a volume related discount to institutions purchasing medicinal products?
• 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?
• Is it possible to offer a refund scheme if the product does not work? If so, what conditions would need to be observed?
• May pharmaceutical companies sponsor continuing medical education? If so, what rules apply?

Hospitality and Related Payments

• What rules govern the offering of hospitality to health professionals?
• Is it possible to pay for a doctor in connection with attending a scientific meeting?
• 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 doctors to attend?
• Is it possible to pay doctors to provide expert services (e.g. participating in focus groups)? If so, what restrictions apply?
• Is it possible to pay doctors to take part in post marketing surveillance studies?
• Is it possible to pay doctors to take part in market research involving promotional materials?

Advertising to the General Public

• Is it possible to advertise non-prescription medicines to the general public? If so, what restrictions apply?
• Is it possible to advertise prescription-only medicines to the general public?
• 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?
• Is it possible to issue press releases concerning prescription-only medicines to non-scientific journals?
• What restrictions apply to describing products and research initiatives as background information in corporate brochures/Annual Reports?
• What, if any, rules apply to meetings with and funding of patient support groups, including any transparency requirement as regards the recording of donations and other support in corporate reports?

The Internet

• How is Internet advertising regulated? What rules apply? How successfully has this been controlled?
• 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 health professionals?
• What rules apply to the content of independent websites that may be accessed by link from a company sponsored site?
• What information may a pharmaceutical company place on its website that may be accessed by members of the public?

General – Medical Devices

• What laws and codes of practice govern the advertising of medical devices in Spain?
• Are there any restrictions on payments or hospitality offered to doctors in connection with the promotion of a medical device?

Developments in Pharmaceutical Advertising

• What have been the significant developments in relation to the rules relating to pharmaceutical advertising in the last year?
• Are any significant developments in the field of pharmaceutical advertising expected in the next year?
• Are there any general practice or enforcement trends that have become apparent in Spain over the last year or so?