Refusal of reimbursement for medicinal products in individual cases in accordance with Article 71a ff. of the KVV

A marketing authorization holder contacted us due to a dispute with a health insurance company in connection with the reimbursement of medicinal products in individual cases based on Article 71a et seq. of the Health Insurance Ordinance.

The health insurance company in question refused to reimburse a drug that was used outside the indication listed in the specialty list (so-called off-label use) and demanded that the marketing authorization holder contribute to the outstanding costs.

In this context, the question also arose as to whether drugs that are used off-label can also be reimbursed in the outpatient sector on the basis of Article 71a ff. of the KVV.

After various correspondence, we were able to reach an agreement with the health insurance company.

Authorization as an outpatient medical institution

For the performance of medical procedures, one company enquired whether these activities require a permit under cantonal health legislation.

We prepared a legal opinion in which we came to the conclusion that such a permit is necessary for the activity to be able to commence in the planned form. We support the company in designing internal processes to ensure compliance with the licensing requirements at all times and to sensitize staff to important elements.

Social media advertising for OTC products

A German marketing authorization holder is planning a completely revamped website for its OTC products and the use of various social media channels (Instagram, TikTok, Facebook, YouTube, Twitter, Snapchat, etc.) in order to be more present and address customers more directly.

Together, we developed an advertising strategy to make a lasting impression on social media as well as in traditional print and TV advertising and still be compliant with all legal requirements.

Medical congresses abroad

A Swiss marketing authorization holder and manufacturer of medicinal products asked us for advice on organizing medical congresses abroad.

We supported the company in compliance issues during the organization of the event and together ensured that the congress was conducted in accordance with the Regulation on Integrity and Transparency in the Therapeutic Products Sector (VITH), the Pharma Code and the EFPIA Code of Practice.

In particular, questions arose regarding the assumption of costs, catering and accommodation as well as advertising materials for the event.

Sample dispatch and sample delivery

A Swiss company with a wholesale license was looking for new solutions in connection with the dispatch of pharmaceutical samples and the drafting of internal guidelines for the distribution of samples to pharmacies and drugstores.

We supported the company in choosing a transport service provider and drew up contracts to ensure that the transport complied with Good Distribution Practice (GDP) and that the medicines were not damaged.

Together, we drew up internal guidelines (Standard Operating Procedure, SOP) that set out simply and clearly the quantities in which specialist and public samples can be dispensed to drugstore and pharmacy specialists in accordance with the provisions of the Ordinance on the Advertising of Medicinal Products (AWV). This has enabled the company to simplify its processes and ensure that samples are dispensed in accordance with Swiss law.

Presentations for training courses

A large pharmaceutical company offers training courses on the handling of its medicines for specialists such as doctors, pharmacists and medical practice and nursing staff. The company approached us to review the implementation and content of the training.

We analyzed the training material, particularly with regard to the requirements of the German Drug Advertising Ordinance, the VITH and the Pharma Code, but also with regard to competition law. Together, we created a guide including a checklist - also for future training courses - to ensure that future training courses are also designed to be compliant.

Warning from competitors

A marketing authorization holder for non-prescription drugs was in a conflict with a competitor. We drafted warning letters for the marketing authorization holder and were thus able to bring them to a round table.

A discussion was held between both parties, which was concluded with an amicable solution.

We support companies in dispute resolution in all areas of life science law (e.g. contract performance, distribution, promotion).

Advertising for aesthetic medical treatments

A leading Swiss company in the field of aesthetic medical treatments approached us to make its advertising on social media and its website compliant. Many products in the aesthetic medical treatment sector are prescription drugs (Rx drugs) for which advertising to the public is not permitted. Advertising for such treatments must therefore be designed precisely.

We supported the company in designing its social media profiles on Instagram, YouTube, TikTok, Snapchat, X (formerly Twitter) and Facebook. We also worked together to ensure that their website complied with all the requirements of the Therapeutic Products Act, the Medicinal Products Advertising Ordinance and, in particular, Swissmedic.

Import of medical devices

A Swiss distributor wanted to conclude an agreement with a foreign dealer and manufacturer of a product for the import of a medical device into Switzerland. We assisted the distributor in negotiating the contract for this international business relationship, taking into account the pitfalls of a cross-border agreement.

During the negotiations, it was determined that fulfilling certain regulatory product requirements was time-consuming. As the product launch was imminent, the product was placed on the market. The risks associated with the import were considered to be manageable.

The product was stopped at the border and assessed by the competent authority. Based on the data made available to it, the authority initially came to the conclusion that the product could not be placed on the market. It granted the right to be heard. After we, together with the manufacturer and the importer, provided additional documentation, which was submitted together with the legal argumentation presented, the authority refrained from taking further measures and allowed the medical device to be placed on the market. This ensured that the client was able to successfully launch its product and the manufacturer gained the necessary time to adapt its products to the new requirements.

Pharmaceutical production

Legal and technical requirements for manufacturing companies

A pharmaceutical manufacturer optimized its production processes as part of the expansion of its product portfolio. We supported the quality assurance (QA) and the responsible person (FvP) in the development of the concept with regard to legal and regulatory issues. The aim was to ensure that all requirements of current good manufacturing practice (cGMP) were taken into account when adapting the quality management system (QMS) for specific products. To this end, we also systematically reviewed internal guidelines (standard operating procedures, SOPs) and compared them with official requirements (guidelines and technical interpretations). This strengthened quality awareness and consolidated quality documentation.

Pharmaceutical marketing on the Internet

A marketing authorization holder and pharmaceutical manufacturer redesigned its website as part of its marketing strategy. We were able to support them in developing the content to ensure compliance with all legal requirements. In addition to its convincing external image, the company has thus strengthened its compliance and sensitized the marketing department to pharmaceutical advertising.

Compassionate Use

Early Access Program: Access to innovative medicines for patients

A pharmaceutical company with a focus on clinical research implemented a compassionate use program at the request of the medical profession. We drew up the necessary contracts for this, tailored to the specific requirements of the intended treatment and the needs of the doctors involved. As a result, patients were able to benefit from a new treatment option at an early stage.

Experimental therapy

Swiss doctors enquired with an international pharmaceutical company about the availability of a medicinal product not approved in Switzerland for the treatment of a fatal disease. This was intended for the treatment of a small number of patients for whom the available standard therapy was not suitable or all treatment options had been exhausted. We advised the company to enable availability in these cases.

Specialist advertising

Compliance and sensitization field service

After updating its product advertising for doctors, a marketing authorization holder requested a legal review of the brochures and documents. We ensured that the advertising content complied with the pharmaceutical advertising regulations and was in line with the information for healthcare professionals. With our many years of experience in advising on pharmaceutical advertising, both for specialists and for the general public, we support marketing departments and the sales force in expanding pharmaceutical advertising compliance with pragmatic solutions.

Financing a health podcast

A pharmaceutical company wanted to financially support the realization of a podcast on health topics. We were able to advise those responsible in matters relating to pharmaceutical law in order to implement this project. In particular, we had to clarify to what extent and under what conditions the podcast could be supported in compliance with legal integrity and transparency regulations.

Grüezi Schwiiz / Hello Switzerland

Gaining a foothold in the Swiss pharmaceutical market with customized solutions

An EU marketing authorization holder of various medicinal products has decided to establish itself in Switzerland. The provision of the medicinal products on the Swiss market had previously been carried out by regulatory third-party providers on its behalf. We provided legal advice on the transfer of the Swiss marketing authorizations and the granting of all operating licences and, in particular, also arranged the replacement of the contracts. Together, we were able to plan and successfully implement optimal solutions for the specific group structure, thereby laying the foundation for independent business activities in Switzerland.

Successfully mastering inspections (GxP)

A provider of therapeutic products services contacted Pharmalex GmbH as part of its periodic basic inspection. We supported them in the legal classification of the Swissmedic guidelines and technical interpretation as well as the GMP and GDP requirements of Eudralex Volume 4 of the EU and PIC/S (Pharmaceutical Inspection Co-operation Scheme). This enabled us to jointly harmonize the GMP and GDP requirements with the existing quality management system.

We advise with pragmatic solutions tailored to specific needs.

Patient leaflet and website

A marketing authorization holder was planning to redesign its website and a patient leaflet for healthcare professionals for one of its herbal medicinal products. In particular, the question arose as to the extent to which websites and patient leaflets for OTC products may contain information on dosage and use.

We worked with the company to review its redesigned website and ensure that it complied with all the requirements of the Medicinal Products Advertising Ordinance. Together, we also formulated a new patient leaflet that doctors can give to their patients.

Sports sponsorship

Tension between pharmaceutical advertising and sports sponsorship

As part of its nationwide promotion concept for sporting activities, a marketing authorization holder for medicinal products was considering a specific sports sponsorship. We supported them in the specific design to ensure compliance with all legal requirements in the area of pharmaceutical advertising.

The standardized sponsorship packages provided for publication on the sponsorship recipient's website. Together, we developed a concept to adapt the specific presentation so that it is permissible as image advertising and as brand advertising for the product.

The sponsorship also enabled the marketing authorization holder to use the logo of the sponsorship recipient in its own advertising. Information in words and images was designed in such a way that the regulations for advertising to the public were complied with.

From A to B via CH

International pharmaceutical distribution

An internationally active pharmaceutical company based in Switzerland handles the Europe-wide distribution of its medicinal products from Switzerland. It was necessary to clarify the conditions under which direct deliveries between EU countries with administrative processing via Switzerland are possible and which authorizations are required for this. All players in the pharmaceutical supply chain must comply with the principles of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) in order to protect patients from falsified medicinal products entering the legal supply chain. With our experience in Swiss and European pharmaceutical law and in matters relating to bilateral agreements (Mutual Recognition Agreement, MRA), we were able to contribute to the design of the distribution structure.

Website for Rx drugs

A foreign marketing authorization holder was planning to authorize and launch a new prescription drug in dermatology in Switzerland. Together, we developed an approval strategy and a campaign for specialist advertising. This involved creating a new website for dermatologists and direct advertising materials. We reviewed the legal aspects of this password-protected website, from the brief specialist information to the authoritative privacy policy for Switzerland.

The content of the website and the advertising materials were checked and designed to be compliant - and yet interesting - particularly with regard to the high requirements of the German Drug Advertising Ordinance.

The website went live successfully and on schedule and the advertising material was sent out on time.

Advertising campaign and vouchers for medicines

A company in the homeopathy sector was planning a new advertising campaign for non-prescription medicines. In addition to the distribution of drug samples, this campaign was also to include the distribution of vouchers.

The company had specific wishes regarding the design of the documents and a limited budget. Together, we were able to pragmatically design a comprehensive advertising campaign and launch it in time for the market launch.

We also advised the company on the design of the vouchers so that they comply with the requirements of Swissmedic and the Medicinal Products Advertising Ordinance (AWV).

Advertising for medicinal products and food supplements

As part of its marketing strategy, a company in the pharmaceutical and food supplement industry created a comprehensive product brochure for its retail partners. We supported the company in reviewing the advertising content, focusing on the implementation of the different legal advertising requirements for pharmaceuticals and food supplements. For this purpose, not only the state regulations but also the industry regulations (Pharma Code) were taken into account. This has also further strengthened the company's compliance efforts.