Refusal to reimburse medicinal products in individual cases under Article 71a et seq. 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 (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 (KVV).
The health insurance company in question refused to reimburse a medicinal product that was used outside the indication listed in the specialities 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 medicinal products that are used off-label can also be reimbursed in the outpatient sector on the basis of Article 71a et seq. KVV.
After various correspondence, we were able to reach an agreement with the health insurance company.
Authorization as an outpatient medical institution
A company enquired whether its planned medical activities required authorisation under cantonal health law.
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.
A company enquired whether its planned medical activities required authorisation under cantonal health law.
We prepared a legal opinion in which we concluded that such authorisation is necessary in order to commence the activity in the planned form. We support the company in designing internal processes to ensure ongoing compliance with the authorisation requirements and to raise staff awareness of key 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 visible and address customers more directly.
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 visible and address customers more directly.
Together, we developed an advertising strategy to create a lasting impression both on social media and in traditional print and TV advertising while remaining fully 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 relating to the organization of the event and together ensured that the congress was conducted in accordance with the Ordinance on Integrity and Transparency in the Therapeutic Products Sector (VITH), the Pharma Code and the EFPIA Code of Practice.
A Swiss marketing authorisation holder and manufacturer of medicinal products asked us for advice on organising medical congresses abroad.
We supported the company with compliance issues in connection with the organisation of the event and together ensured that the congress was conducted in accordance with the Ordinance 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 for shipping drug samples and drafting internal guidelines for sample distribution to pharmacies and drugstores.
A Swiss company with a wholesale license was looking for new solutions for shipping drug samples and drafting internal guidelines for sample distribution to pharmacies and drugstores.
We supported the company in selecting a transport service provider and drafted contracts to ensure that the transport complies with Good Distribution Practice (GDP) and that the medicines are not damaged.
Together, we drafted internal guidelines (Standard Operating Procedure, SOP) that clearly and simply specify the quantities in which samples for professionals and the general public can be distributed to professionals in drugstores and pharmacies in accordance with the provisions of the Ordinance on the Advertising of Medicinal Products (AWV). This enabled the company to simplify its processes and ensure that samples were distributed 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.
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 Ordinance on the Advertising of Medicinal Products, the TPITO and the Pharma Code, but also with regard to competition law. Together, we created a guide including a checklist, for future training courses to ensure that they are also designed in a compliant manner.
Warning to competitors
A marketing authorisation holder for non-prescription medicinal products found itself in a conflict with a competitor. We drafted warning letters for the marketing authorisation holder and were thus able to bring them to a negotiating table.
A marketing authorisation holder for non-prescription medicinal products found itself in a conflict with a competitor. We drafted warning letters for the marketing authorisation holder and were thus able to bring them to a negotiating table.
A meeting was held between the two parties, which resulted in an amicable settlement.
We support companies in dispute resolution in all areas of life sciences 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 ensure that its social media advertising and website are compliant. Many products used in the aesthetic medicine sector are prescription-only medicinal products (Rx medicinal products) for which advertising to the general public is not permitted, meaning that advertising for such treatments must be drafted with particular precision.
A leading Swiss company in the field of aesthetic medical treatments approached us to ensure that its social media advertising and website are compliant. Many products used in the aesthetic medicine sector are prescription-only medicinal products (Rx medicinal products) for which advertising to the general public is not permitted, meaning that advertising for such treatments must be drafted with particular precision.
We supported the company in designing its social media profiles on Instagram, YouTube, TikTok, Snapchat, X (formerly Twitter) and Facebook. Together, we also ensured that its website complies with all the requirements of the Therapeutic Products Act, the Ordinance on Advertising of Medicinal Products and, in particular, Swissmedic practice.
Import of medical devices
When negotiating contracts between manufacturers and distributors, it is necessary to check the available certificates for medical devices for accuracy. Good contractual relationships between trading partners can only be achieved through knowledge of the potential risks associated with the regulatory requirements.
A Swiss distributor wished to conclude an agreement with a foreign trader and manufacturer for the import of a medical device into Switzerland. We supported the distributor in negotiating the contract for this international business relationship, taking into account the pitfalls inherent in a cross-border agreement.
During the negotiations, it became apparent that fulfilling certain regulatory product requirements would be onerous. As the product launch was imminent, the product was placed on the market, and the risks associated with the import were assessed as manageable.
At the border, the product was stopped and assessed by the competent authority. Based on the data provided, the authority initially concluded 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 and submitted it together with our legal arguments, 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 their product and that the manufacturer gained the time needed to adapt its products to the new requirements.
Pharmaceutical manufacturing
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 in legal and regulatory matters.
Legal and technical requirements for manufacturing companies
A pharmaceutical manufacturer optimised its production processes as part of an expansion of its product portfolio. We supported quality assurance (QA) and the responsible person (FvP) in developing the concept with regard to legal and regulatory issues, ensuring that all product-specific requirements of current good manufacturing practice (cGMP) were taken into account when adapting the quality management system (QMS). For this purpose, we also systematically reviewed internal guidelines (Standard Operating Procedures, SOPs) and compared them with regulatory 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 asked to assist in developing the content to ensure compliance with all legal requirements.
A marketing authorisation holder and manufacturer of medicinal products redesigned its online presence as part of its marketing strategy. We assisted the company in developing the content in order to ensure compliance with all legal requirements. In doing so, the company not only strengthened its external profile but also enhanced its compliance and raised awareness within the marketing department regarding advertising for medicinal products.
Compassionate Use
Early Access Program: Access to innovative medicines for patients
A pharmaceutical company with a focus on clinical research has implemented a compassionate use program at the request of the medical profession.
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 have enquired with an international pharmaceutical company about the availability of a drug not approved in Switzerland for the treatment of a fatal disease as part of an experimental trial.
Swiss physicians contacted an international pharmaceutical company regarding the availability of a medicinal product not authorised in Switzerland for the treatment of a fatal disease. The product was intended for the treatment of a small number of patients for whom the available standard therapy was unsuitable or for whom all therapeutic options had been exhausted. We advised the company in order to enable the availability of the medicinal product in these cases.
Advertising to healthcare professionals
Compliance and awareness in the 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.
Compliance and awareness in the field service
A marketing authorisation holder requested a legal review of brochures and documents following an update of its product advertising aimed at physicians. We ensured that the advertising content complies with the medicinal product advertising regulations and is consistent with the summary of product characteristics.
Drawing on many years of experience in advising on medicinal product advertising, both for professionals and for the general public, we support marketing departments and the sales force in expanding advertising compliance through pragmatic solutions.
Financing a health podcast
A pharmaceutical company wanted to provide financial support for the creation of a podcast on health topics. We were asked to advise those responsible on matters relating to therapeutic products law in order to implement this project.
A pharmaceutical company planned to provide financial support for the production of a podcast on health-related topics. We advised those responsible on issues of therapeutic products law in order to implement the project. In particular, it was necessary to clarify to what extent and under which conditions the podcast may be supported while complying with the statutory integrity and transparency requirements.
Grüezi Schwiiz / Hello Switzerland
Gaining a foothold in the Swiss pharmaceutical market with customised solutions
An EU marketing authorization holder for various medicinal products has decided to establish itself in Switzerland. Until now, third-party providers had been responsible for supplying the medicinal products to the Swiss market on its behalf.
Gaining a foothold in the Swiss pharmaceutical market with customised solutions
An EU marketing authorisation holder for various medicinal products has decided to establish itself in Switzerland. Until now, third-party providers had been responsible for supplying the medicinal products to the Swiss market on its behalf. We provided legal support for the transfer of Swiss marketing authorisations and the granting of all operating licences, and in particular also structured the orderly termination and replacement of the existing contractual arrangements. Together, we planned and successfully implemented solutions tailored to the group’s specific structure, thereby laying the foundation for the company’s independent business operations in Switzerland.
Successfully mastering inspections (GxP)
A provider of therapeutic products services contacted Pharmalex GmbH as part of its periodic basic inspection. We advised them on the legal classification of the Swissmedic guidelines and technical interpretation as well as...
A provider of therapeutic products regulatory services contacted us as part of its periodic basic inspection. We supported the company in the legal assessment of Swissmedic guidelines and technical interpretations, as well as the GMP and GDP requirements under Eudralex Volume 4 of the EU and PIC/S (Pharmaceutical Inspection Co-operation Scheme). This allowed us to align the applicable GMP and GDP requirements with the existing quality management system.
Our advice focuses on pragmatic solutions carefully tailored to the client’s specific needs.
Patient leaflet and website
A marketing authorisation holder planned to redesign its website and a patient leaflet for healthcare professionals for one of its herbal medicinal products. The key question was the extent to which websites and patient leaflets for Over-the-Counter (OTC) products may contain information on dosage and use.
A marketing authorisation holder planned to redesign its website and a patient leaflet for healthcare professionals for one of its herbal medicinal products. The key question was the extent to which websites and patient leaflets for Over-the-Counter (OTC) products may contain information on dosage and use.
We reviewed the company’s redesigned website and ensured that all requirements of the Ordinance on Advertising of Medicinal Products were complied with. Together, we also drafted a new patient leaflet that physicians can hand out to their patients.
Sports sponsorship
Tension between medicinal product advertising and sports sponsorship
As part of its nationwide strategy to promote sporting activities, a marketing authorisation holder for medicinal products planned a specific sports sponsorship initiative. We assisted the company in designing the sponsorship so that it fully complies with the legal requirements on medicinal product advertising.
Tension between medicinal product advertising and sports sponsorship
As part of its nationwide strategy to promote sporting activities, a marketing authorisation holder for medicinal products planned a specific sports sponsorship initiative. We assisted the company in designing the sponsorship so that it fully complies with the legal requirements on medicinal product advertising.
The standardised sponsorship packages provided for publication on the sponsor recipient's website. Together, we developed a concept to adapt how this presence is displayed so that it qualifies as permissible image advertising and brand advertising for the product.
The sponsorship also allowed the marketing authorisation holder to use the sponsored organisation’s logo in its own advertising. We designed the wording and visuals in such a way that all rules on advertising to the general public were complied with.
From A to B via CH
International distribution of medicinal products
An internationally active pharmaceutical company based in Switzerland handles the Europe-wide distribution of its medicinal products from Switzerland. The task was to clarify the conditions under which direct deliveries between EU countries with administrative processing via Switzerland are possible and...
International distribution of medicinal products
An internationally active pharmaceutical company based in Switzerland manages the Europe‑wide distribution of its medicinal products from Switzerland. The key questions were under which conditions direct deliveries between EU countries with administrative processing via Switzerland are possible and which authorisations are required for this purpose.
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. Drawing on our experience in Swiss and European pharmaceutical law as well as in matters relating to the bilateral agreements (Mutual Recognition Agreement, MRA), we were able to contribute to the design of the distribution structure.
Website for Rx medicinal products
A foreign marketing authorization holder was planning to authorize and launch a new prescription-only medicine 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.
A foreign marketing authorisation holder planned to obtain authorisation in Switzerland and launch a new prescription-only dermatology medicinal product. Together, we developed a regulatory approval strategy and a campaign for advertising to healthcare professionals. This included creating a new website for dermatologists as well as direct promotional materials. We reviewed the legal aspects of this password‑protected website, from the abbreviated professional information through to the relevant data protection declaration for Switzerland.
The content of the website and the advertising materials were designed and reviewed in light of the stringent requirements of the Ordinance on Advertising of Medicinal Products, ensuring compliance while remaining engaging.
The website went live on schedule and the advertising materials were sent out on time.
Advertising campaign and vouchers for medicinal products
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.
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 ideas regarding the design of the materials and a limited budget. Working together, we were able to develop a pragmatic, comprehensive advertising campaign and launch it in time for the market introduction.
We also advised the company on structuring the vouchers so that they comply with the requirements of Swissmedic and the Ordinance on Advertising of Medicinal Products (AWV).
Advertising for medicinal products and food supplements
As part of its marketing strategy, a company in the pharmaceutical and dietary supplement industry created a comprehensive product brochure for its retail partners. We supported the company in reviewing the advertising content, whereby...
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.