Summarize the rules for advertising and marketing of medicines and medical devices, explain when the provision of information will be treated as advertising. Do special rules apply to online advertising?
The Medicines Act contains special provisions on the marketing of medicines, while Marketing Practices Act (2008: 486) refers to marketing in general (ie including marketing of medicines and medical devices). MDR and IVDR contain a ban on misleading marketing of medical devices (see chapter in the European Union).
In short, the definition of “advertising of medicinal products” as described in EU Directive 2001/83 / EC (the Pharmaceuticals Directive) corresponds to the interpretation of when the provision of information will be treated as advertising in accordance with the Medicines Act. In addition, the MPA Regulation LVFS 2009: 6 lists several measures that should specifically be included in the definition of marketing of medicinal products. The MPA regulation LVFS 2009: 6 also lists several measures that are not to be regarded as marketing of medicines. These measures also correspond to the measures mentioned in the Medicines Directive (see Chapter of the European Union).
The Marketing Act applies to all forms of marketing, including online marketing. According to the Marketing Act, the term “advertising” is seen as part of the broader concept of “marketing”. Even the sale itself, even if it is completely passive, is considered a marketing measure. In addition, measures aimed at promoting the range of products are included in the definition.
The framework for ethical rules for the pharmaceutical industry in Sweden (the LER rules) of the Pharmaceutical Industry Association (LIF) also contains rules on information about medicines. Furthermore, if a company is covered by the LER rules, it will be able to apply for permission from the Swedish Pharmaceutical Industry Information Examiner Committee (IGN) to provide information about the drug on a special website. The information on the website must be reviewed by IGN before it is published and before any changes can be made. Due to the ban on advertising of medicines directly to consumers, companies may not refer to or in any way market their information website. This means that consumers have to find the website on their own.
What rules exist to discourage healthcare professionals from prescribing, selling, providing or recommending the use of a particular drug or medical device?
In addition to general penal rules on bribes that follow Criminal Code (1962: 700)The LER rules from LIF prescribe specific provisions on the efforts of healthcare professionals with regard to medicines.
Any form of cooperation between healthcare professionals and pharmaceutical companies where some form of compensation has taken place must be documented. Donations from the company are only allowed if they support research and development. The only gifts that are allowed are information and educational materials, provided that the materials are of low value, directly relevant to the recipient’s practice and directly beneficial to the care of patients. Medical items can be provided for the training of employees and for the care of patients, provided that the item is of low value and not so that it is routinely used in the recipient’s business. Furthermore, it is not permitted to give healthcare professionals a cheap gift that is not related to medication on a rare basis in recognition of significant national, cultural or religious holidays.
According to the collaboration agreement entered into with LIF, among others, medical technology companies are not permitted to offer benefits, gifts or other compensation to healthcare staff. Gifts offered to medical units (eg hospitals) that can be considered as indirect gifts to healthcare professionals working within the medical unit are therefore also prohibited. Donations may never be offered or solicited to fund healthcare’s internal or regular activities. Donations to healthcare are only permitted if they are made to support research and development and provided that the donation is transparent, well-documented and in accordance with the collaboration agreement and its intentions.
There is a specific rule in the industry code that states that donations and contributions to health care should not be linked to past, present or potential future use, recommendation, sale or prescription of the donor’s products or services, and may not constitute an invitation to recommend , prescribe, buy, deliver, sell or administer specific drugs.
Report value transfers
What requirements apply to the registration and publication of information on value transfers to healthcare professionals and organizations from companies that market medicines or medical devices?
LIF’s ethical rules correspond to the European Federation of Pharmaceutical Industries and Associations Discloser Code in this matter. Direct or indirect value transfers, either in cash, in kind or otherwise, made for advertising purposes or otherwise in connection with the development and sale of prescription drugs exclusively for human use, to a healthcare professional or organization shall be recorded and published by the pharmaceutical company. In accordance with the co-operation agreement between, among others, LIF and the industry organization Swedish Medtech, the documentation principle applies to (affiliated) medical technology companies with regard to value transfers. These companies are therefore obliged to document information on value transfers, but they do not have to publish this information.
Application of advertising rules
Describe the bodies involved in the monitoring and compliance of advertising controls for medicinal products and medical devices, and distinguish between all self-regulatory frameworks and regulatory controls.
With regard to law enforcement, the Medical Products Agency (MPA) is responsible for monitoring compliance with the Pharmaceuticals Act and the regulations for medical devices (or, where applicable, the Pharmaceuticals Act and any regulations issued on the basis of the law). The Marketing Act is applied by the Swedish Consumer Agency.
For self-regulation, the Association of the Pharmaceutical Industry (LIF), the Information Examiner Committee and the Information Practices Committee have a duty to ensure that LIF’s members follow their framework for ethical rules for the pharmaceutical industry in Sweden.
What are the possible financial or other sanctions for violations of advertising and marketing controls for medicines or medical devices?
The MPA has the right to demand information and issue the orders and prohibitions necessary to ensure that the Pharmaceuticals Act, the regulations for medical devices (or, where applicable, the Medical Devices Act and all ordinances issued based on the Act) are complied with. Such demands, orders and prohibitions can be linked to fines.
Sanctions that are available under the Marketing Methods Act consist of prohibitions or orders together with fines, fines for disruptive marketing methods and damages.
Pricing and compensation
What controls apply to the pricing of medicines and medical devices and reimbursement from national social security systems applicable to manufacturers, distributors and pharmacists?
The Dental and Pharmaceutical Benefits Agency (TLV) is responsible for deciding whether a pharmaceutical product or consumables should be eligible for reimbursement and included in the Swedish benefit system. TLV is responsible for determining the purchase and sales price for these products. These decisions are taken in accordance with The Act on Pharmaceutical Benefits (2002: 160). The prices are based on an ethical platform with three basic principles:
- the principle of human dignity;
- the need and the principle of solidarity; and
- the cost-effectiveness principle.
The Swedish healthcare benefit system consists of two parts: subsidization of medicines and consumables and a “high-cost limit”. Sweden applies a high-cost threshold for prescription drugs and consumables, which means that patients only have to pay for these products up to a certain threshold; all prescription drugs and consumables are then free. The high-cost threshold begins to apply after purchases of up to SEK 1,150 for prescription drugs and consumables over a 12-month period. However, not all products are included in the high-cost limit, even though the system covers many types of medicines and consumables.
Sales and delivery
Are there special rules for dispensing or selling special types of medicines or medical devices?
To dispense or sell over-the-counter medicines, Shop with over-the-counter drug companies (2009: 730) applies. For dispensing or selling prescription drugs, Shop with prescription drugs (2009: 366) and the ordinance (2009: 659) on trade in medicines applies as well as the ordinance on medical medicines authorities (MPA) LVFS 2009: 8. Each of these laws states which medicines can be sold according to the law. Both the dispensing or sale of over-the-counter medicines and the dispensing or sale of prescription medicines require a permit from MPA. There is no requirement for a marketing authorization for medical devices, but there are different registration requirements for different types of operators.
What laws and guidelines govern online dispensing, sales and delivery of medicines and medical devices?
A pharmacy that wants to sell medicines online must inform MPA in connection with the application to run a pharmacy or at least two months before the e-commerce starts. The common EU symbol must be used by pharmacies that are licensed to sell online. for such use, the pharmacy must enter into a licensing agreement with MPA. Online sales are regulated by the Act on Trade in Prescription Medicines (2009: 366), the Ordinance (2009: 659) on trade in medicinal products and the MPA Ordinance LVFS 2009: 8.