The pharmaceutical industry is dominated by a large number of different regulations. There are high demands not only on the products, but also on the operators in their commercialization and marketing. Setterwalls provides legal advice in all areas and throughout the life cycle of a pharmaceutical, with everything from various agreements such as research and development agreements to commercialization issues such as subsidies, pricing, distribution, substitution at pharmacies and marketing measures.
A substance or combination of substances can be considered a medicinal product either by its properties (medicinal product by function) or by how it is marketed (medicinal product by presentation). The assessment of whether a particular product is considered to be a medicinal product is often both technically and legally complex. Demarcation issues often arise where Setterwalls can assist.
We assist our clients with drawing up various types of agreements such as Material Transfer Agreements, clinical trial agreements, research and development agreements, licensing agreements and distribution agreements. When it comes to clinical trials, we also provide advice on documentation of informed consent and ethics review.
In order to be able to sell pharmaceuticals in Sweden, a permit is required from the Swedish Medical Products Agency or the European Medicines Agency, EMA. As a regulatory authority, the Swedish Medical Products Agency can also prohibit the sale of a product that the authority considers to be a medicinal product if there is no marketing authorization or such authorization has been violated. A marketing ban is often associated with high penalties. Such a decision can be appealed and Setterwalls can assist in such a process.
An authorized pharmaceutical can be included in the pharmaceutical benefits scheme, and is then covered by the subsidy system. Whether a pharmaceutical should be included in the benefits scheme, and what price the pharmaceutical should have, is decided following an application by the pharmaceutical company to the Dental and Pharmaceutical Benefits Agency, TLV, taking into account the principle of human dignity, needs and solidarity and cost-effectiveness. In such processes, questions are also raised regarding, for example, discussions with the county councils and tripartite agreements, all issues in which Setterwalls can assist.
Other regulatory issues that can be raised for pharmaceuticals, and where Setterwalls’ Life Sciences’ team can assist, include, for example, manufacturing permits, labeling of pharmaceuticals, the legal conditions for extemporaneous medicines, stock manufacturing, licensed medicines as well as parallel imports and parallel distribution of medicines.
Pharmaceutical companies are also subject to special rules regarding collaboration and cooperation between industry and healthcare or other authorities. Issues that are raised concern, among other things, the design of collaborative projects, consultation, sponsorship and donations.
Furthermore, there are a large number of rules to adhere to when marketing pharmaceuticals. In addition to general requirements such as objectivity and reliability, for example, the marketing of prescription medicines may not, as a general rule, be directed directly at consumers, while marketing directed at healthcare personnel must contain certain information. Setterwalls regularly reviews pharmaceutical advertising and other marketing activities in the area and frequently handles issues related to public procurement.
No matter what legal issues or problems arise regarding medicines, whether relating to contractual law, intellectual property, procurement law, regulatory or marketing law, Setterwalls’ team of experienced and skilled lawyers is ready to assist.