Marketing authorisation

The research-based pharmaceutical industry researches, develops and manufactures innovative medicinal products that prevent and cure diseases, relieve pain and improve patients’ quality of life. In recent decades, the research-based pharmaceutical industry has brought products onto the market in many therapeutic areas, enabling major progress to be made in alleviating diseases and, in some cases, also curing them. Yet in spite of this great progress in medicine, there are still no suitable therapies available for two-thirds of all known diseases.

Rigorous safety reviews for therapeutic products

The safety, quality and efficacy of medicines are of central importance for patients. In Switzerland, Swissmedic, the Swiss Agency for Therapeutic Products, is responsible for ensuring these aspects. Following a comprehensive review, it decides whether or not a medicinal product can be authorised to be placed on the market.

The research-based pharmaceutical industry provides the health authorities with extensive data from preclinical and clinical trials, and this forms the basis for an assessment of the quality, efficacy and safety of a medicinal product. The provision of this information involves an enormous amount of time and expense. It generally takes between 10 and 15 years to discover and develop a new medicine. This work involves costs in excess of CHF 1.2 billion.

Clinical trials

For patients, it is important that clinical trials are carried out in their country because clinical trials are one way of gaining access to the latest developments. Whether or not a country is an attractive place to perform clinical trials depends, among other things, on how competitive the framework conditions are. In Switzerland, the Human Research Act regulates the requirements for performing clinical trials in this country. Together with the implementing ordinances, it came into effect at the start of 2014.

High quality requirements

The conditions governing the authorisation of medicinal products are regulated in the Therapeutic Products Act (TPA). This states that medicines may only be dispensed if they comply with the legal and internationally harmonised requirements in terms of safety, efficacy and quality. Swissmedic, the competent authority in such matters, decides whether a medicinal product may only be sold on presentation of a doctor’s prescription (prescription-only) or without a prescription but with professional advice (prescription-free). Manufacturers must all comply with the same legal requirements for safety and quality.

Rapid access for patients to high-quality therapeutic products and new treatments requires a competent, independent and internationally recognised medicines agency to regulate these products, something that is also in the fundamental interest of the export-based pharmaceutical industry.

Drug safety is the top priority

The integrity of the channels through which medicines are distributed is of increasing importance for patients. Counterfeit medicines represent a growing threat to patients’ safety and, in a worst-case situation, to their survival. The threat posed to public health by counterfeit medicines can only be averted if the necessary awareness of the issue exists, the need to act is acknowledged and a joint effort is made by the partners operating at all stages of the pharmaceutical supply chain.