The supply of medicines in Switzerland can no longer be assured in all cases. The measures taken so far have not yet had the desired effect. The federal government is now looking into additional steps to counter shortages of medicines.
Bottlenecks in the supply of medicines (medicinal products and vaccines) are on the increase all over the world, and in Switzerland too. Evidence of this can be found in the lists of supply disruptions maintained by the reporting office of the Federal Office for National Economic Supply (FONES) and private initiatives such as drugshortage.ch. The media and national politics have taken up the theme on multiple occasions and are calling for solutions.
Various groups of medicines are affected, but cancer drugs and vaccines in particular. These bottlenecks and gaps in the supply of medicinal products are primarily due to the laws of economics:
- The economic pressure created by globalisation is resulting in the centralisation of production at a small number of locations.
- There are heavy fluctuations in demand, particularly for vaccines.
- Lean inventory management is leading to low stocks at the end of the supply chain.
- The impact of failures and quality problems in the manufacturing chain is global rather than limited to a specific locality.
To improve this situation, further measures have to be taken in addition to those already initiated by the federal and cantonal authorities. There needs to be coordinated collaboration between the federal and cantonal authorities, service providers and the industry, and a cross-border approach has to be adopted. There also needs to be clarity on what (additional) tools and mechanisms will have the greatest possible impact in terms of improving the supply situation in the long term.
To this end the FOPH is working on a report, due for completion by spring 2020, outlining the interdependencies within the entire supply chain (from manufacture, storage and market access to pricing and remuneration) and proposing a catalogue of measures.
Insights from the 2016 report on the supply of medicines
Basically the supply of medicines in Switzerland is subject to free market mechanisms. The supply mandate lies with the cantons rather than with the federal government. In the Heim postulate (12.3426) procedural request of 4 June 2012, the Federal Council was charged with producing a report analysing the supply situation in Switzerland and showing how the federal authorities could support the cantons with the supply of medicines.
In its report on the security of drug supply of 20 January 2016, the Federal Council still concluded that the drug supply situation did not merit urgent intervention by the federal authorities. It did, however, recommend initiating precautionary measures enabling the federal and cantonal authorities to effectively improve the secure and regular supply of medicines in the long term.
The report formulated recommended actions for the federal government and the cantons. In the meantime various measures have been implemented, but it is too early to assess their impact.
Since autumn 2015, Switzerland has had an up-to-date system for monitoring the supply situation in the form of the Reporting Office for Vital Medicinal Products for Human Use at the FONES, and in acute cases can take rapid and unbureacratic action (for example supplying the market from compulsory stocks).
Four areas of action
The 2016 report basically deems measures related to storage and decentralised manufacture to be a success. 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.
To improve the situation there needs to be coordinated collaboration between the federal and cantonal authorities, service providers and the industry.
An Interdepartmental Working Group of the Federal Department of Home Affairs (FDHA), the Federal Department of Economic Affairs, Education and Research (EAER) and the Federal Department of Defence, Civil Protection and Sport (DDPS) will prioritise the measures proposed in the spring 2020 report and set down clear responsibilities and implementation steps.
Measures will be looked into where there is national room for manoeuvre (for example increasing the stocks of all scarce medicines kept at all levels of the supply chain (industry and cantons), expanding the compulsory stock requirement beyond essential drugs, or further easing in terms of approval and imports). The idea is also to examine approaches to solving the problem in other countries and existing and planned international initiatives.
Last modification 13.11.2019