The security in the supply of medicines in Switzerland is good, even if in the last few years isolated bottlenecks have occurred. This conclusion is the result of a report by the Federal Council in response to the postulate Heim (12.3426).
Shortages and bottlenecks in the supply of medicinal products have repeatedly been the subject of political and public debate in recent months and years. Parliament has already reacted to bottlenecks in the supply of medicinal products in Swiss hospitals by bringing forward the revision of the Therapeutic Products Act (1st stage). The revised Act substantially expands the options for manufacturing medicinal products that do not require a licence. The Heim postulate (12.3426) requested the Federal Council on 4 June 2012 to provide a report that analysed the supply situation in Switzerland again, showing where the causes and problem areas lie and how the Confederation can support the cantons in this matter.
Findings from the report relating to the Heim postulate
In its report to Parliament, which was published on 20 January 2016, the Federal Council concludes that, generally speaking, drug availability in Switzerland is good and reliable. It is nonetheless possible for shortages and bottlenecks to occur in the complex supply chain. Primarily affected are cancer drugs, niche products and vaccines.
The report further concludes that the current drug supply situation does not require any urgent federal intervention. Since autumn 2015, the Reporting Office for Vital Medicinal Products for Human Use (Meldestelle für lebenswichtige Humanarzneimittel), which is part of the Federal Office for National Economic Supply, has been providing Switzerland with up-to-date monitoring of the supply situation and can take prompt and unbureaucratic action in the case of any acute event. At the same time, however, drug supply bottlenecks are a worldwide phenomenon and appear to be increasing. Further measures should thus be initiated as a precaution to allow the Confederation and the cantons to effectively improve the reliable and orderly supply of medicines throughout the country in the long term. The report formulates appropriate recommendations for action for the attention of the Confederation and the cantons.
Four areas of action
Measures for storage and decentralised manufacture are deemed particularly successful. A minimum storage at all levels is recommended – from manufacturers to hospitals to doctors – as is an extension of compulsory stockpiling by the marketing authorisation holder for vital medicinal products. In the area of manufacturing, a network of public pharmacies, hospital pharmacies and the Armed Forces Pharmacy would be conceivable in order to safeguard domestic production of certain niche products.
Facilitating market access could increase the availability of drugs. In this connection, the simplification of Switzerland-specific requirements for patient information is recommended for certain medicinal products, in order to expedite their import. In addition, requirements for the authorisation of traditional medicinal products from the EU and EFTA areas should be relaxed. Furthermore, manufacturers should be encouraged by the Swiss government to assign licences to third parties if they remove their products from the Swiss market.
In connection with pricing and remuneration, options should be investigated for considering the availability of medicinal products as a criterion in fixing their price.
These findings and recommendations are based on different studies carried out by the FOPH in connection with the Heim postulate, including a literature study, a survey of representative stakeholders and a systemic analysis.
Implementation of the recommendations and proposed measures will be pursued within the masterplan framework for the promotion of biomedical research and technology. A number of recommendations have already been adopted as part of the revision to the Therapeutic Products Act (2nd stage). These relate primarily to the recommendations on market access mentioned above. In addition, the flow of information on withdrawals of medicinal products from the market should be improved and the development of medicinal products for rare diseases and specifically for children should be encouraged through appropriate incentives. Furthermore, in the course of this work, rules should be defined on how to link operating licences for wholesalers to conditions for universal supply (see recommendations and further action to improve the security in the supply of medicines in Switzerland, document non available in English).
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Last modification 17.08.2018