The supply of medicines in Switzerland is not assured in all cases. Despite the action already taken, no significant improvement has been achieved. The federal government is now considering additional measures and is drawing up proposals for implementing them.
Disruptions to the supplies of medicines are increasing worldwide, and Switzerland is no exception. The problem is clearly reflected in the growing numbers of reports to the Essential Human Medicines Reporting Office for National Economic Supply (NES), and through information obtained from hospital and cantonal pharmacies.
The vast majority of such disruptions involve generic medicines, i.e., medicines whose patent protection has expired. These include various groups of medicines. As the growing number of submissions to the Essential Human Medicines Reporting Office for National Economic Supply (NES) shows, strong painkillers (e.g., opioids), vaccines and antibiotics are particularly affected.
The Swiss media and Swiss policymakers have also addressed these issues on multiple occasions. SRF (Swiss Radio & TV), for instance, has investigated the issue of supply chain security, and has also produced a video for younger audiences (in German) explaining why there are shortages of certain medicinal products: SRF Kids News - Warum fehlen so viele Medikamente?.
The causes of disruption in the supply of medicines
The causes of such disruption and the consequences thereof are complex. They are largely of global origin, and have evolved over the decades. In addition to the global causes, there are also some Switzerland-specific characteristics which may promote such supply disruption. These causes and consequences can be summarised as follows:
1 Economic pressures, subsidisation policies and looser regulatory provisions in low-wage countries have led to a globalisation of the pharmaceuticals sector.
2 Vital parts of the value chain, including the production of key active pharmaceutical ingredients (APIs), have been relocated to Asia (e.g. China and India).
3 The concentration on a handful of suppliers and the resulting interdependencies have substantially increased. Around a third of the APIs used in the US generic medicines market are now supplied by a single provider, and a further third are supplied by just two or three providers.
4 Today’s supply chain concepts such as just-in-time delivery result in fewer reserves being maintained throughout the value chain. Just-in-time supply and production is a synchronous-with-demand production approach in which the materials needed are delivered in the precise quantities and at the precise time required for the product’s manufacture.
5 The failure and cluster risks to which global supply chains are exposed have increased, and this in turn has weakened their resilience. To take one example, China’s zero-COVID policy prompted the closures of many the country’s production facilities. India, which obtains most of its APIs from China, feared an imminent shortage of the APIs concerned, and thus promptly halted its exports of 26 medicinal products including Paracetamol, antibiotics such as Erythromycin, Clindamycin and Metronidazol and the antiviral medication Aciclovir. The ramifications of these actions are still being felt.
6 To bring a medicine to market in Switzerland, a manufacturer must have its products approved in accordance with Swiss regulations.
7 For the globally-focused pharmaceutical industry, the Swiss market is relatively small by international standards and thus not particularly attractive in economic terms.
8 Demand is showing strong fluctuations. And, for the reasons outlined above, the markets cannot respond to such fluctuations with sufficient speed.
To tackle such disruptions at their source, international solutions are required which need to be approached in collaboration with other countries. The measures that can be taken in Switzerland will have little impact on the global causes of supply disruptions. Domestic measures can, however, help establish better framework conditions, which in turn can permit more efficient and more effective responses to the disruptions concerned.
What the Swiss Confederation has done so far in response
In accordance with the Federal Act on National Economic Supply (National Economic Supply Act, NESA, SR 531), the responsibility for ensuring that Switzerland is adequately supplied with medicinal products (and also with other goods) lies primarily with the private sector (Art. 3 NESA). At the state level, responsibility for medicinal care lies with the cantons. In accordance with the Federal Constitution (Cst. SR 101), the Swiss Confederation can only act subsidiary in guaranteeing the country's supply of essential goods in times of severe shortage that the economy cannot by itself counteract (Art. 102 Cst.). However, the FOPH has already undertaken a number of actions in collaboration with the NES Therapeutic Products Division to improve the supply situation on the medicinal products front.
2006 The Federal Council takes the first actions to improve supply chain security.
2009 The first phase in the revision of the legislation on therapeutic products lays the legal foundations to enable hospitals to better ensure that their patients can be provided with the medicines they require.
2012 The Federal Council is mandated through a parliamentary postulate (Heim Postulate 12.3426) to analyse the supply situation in Switzerland.
2015 The NES puts its Essential Human Medicines Reporting Office into operation.
2016 The Security in the Supply of Medicinal Products Report from the Federal Council in response to the Heim Postulate of 2012 proposes structural and procedural actions for both the Confederation and the cantons which should effectively improve the secure and orderly supply of medicinal products for the longer term.
2019 With the second phase in the revision of the legislation on therapeutic products, the changes proposed under the Heim Postulate enter into effect. Under these, the Federal Council takes various actions to expand the scope available to the parties responsible for ensuring the provision of medicinal products for patients. These include expanded possibilities of own production and of importing medicinal products not available in Switzerland.
2019 To steadily expand the actions already taken by the Confederation and the cantons, the FOPH is commissioned together with the Therapeutic Products Division of the NES, Swissmedic and the Armed Forces Pharmacy to conduct a renewed analysis of supply chain security in Switzerland and devise a corresponding catalogue of actions.
2022 The ‘Disruptions of Supplies of Medicinal Products for Human Use in Switzerland: situational analysis and improvements to be considered’ report is formally acknowledged by the Federal Council on 16 February 2022.
2022 With the publication of the Disruptions of Supplies Report, the Federal Department of Home Affairs/FDHA (and the FOPH in particular) and the Federal Department of Economic Affairs, Education and Research/EAER (and the NES Therapeutic Products Division in particular) are commissioned to work with the Federal Department of Defence, Civil Protection and Sport/DDPS (and the Armed Forces Pharmacy in particular) along with further relevant stakeholders from the healthcare sector to study the actions listed in the report in greater depth and devise concrete proposals on how they may be implemented.
2023 The Federal Council approves the request from the NES Therapeutic Products Division to expand reporting requirements and digitalise the reporting process and the associated monitoring activities.
2024 In January, the Federal Council instructs the EAER to develop a high-performance, future-oriented monitoring platform for therapeutic products.
2024 In August, the Federal Council takes note of the 2024 Final Report «Implementation proposals for the measures of the FOPH report on shortages in the supply of medicinal products, final report of the interdisciplinary working group». This contains the results of the appraisal together with implementation proposals for improving the supply situation for medicines in Switzerland, drawn up by an interdisciplinary working group of experts from teaching, research, industry, service providers, the cantons and the federal government. Fourteen proposals for implementation are submitted in the following areas of action: roles of the different actors, storage of essential medicines, market access, incentives for manufacturers and the Confederation’s own production and/or procurement, and international cooperation. The Federal Council instructs the FDHA, the EAER and the DDPS to follow up these proposals and develop bases for decision-making.
The implementation proposals can make the system more resilient to supply disruptions and are intended to initiate structural change in the area of drug supply.
Implementation of the findings of the FOPH Disruptions of Supplies Report of 2022
To strengthen medicinal supplies in the long term, the Swiss Confederation (the FOPH, the NES Therapeutic Products Division and the DDPS/Armed Forces Pharmacy) is specifying the catalogue of actions specified in the FOPH’s Disruptions of Supplies Report of 2022 and is developing concrete proposals on how these can be implemented. To these ends, the Confederation is also involving various stakeholders from further fields such as the industry, research, service providers, representatives of different associations and of the cantons. The work is progressing on various fronts, and the proposals will gradually be adopted. They have also been grouped into eight subprojects.
Subproject 1
- Subproject 1, ‘Monitoring and analysing supply disruptions’, which is led by the NES Therapeutic Products Division, devised implementation proposals for expanding the reporting requirements and for digitalising the reporting process and the associated monitoring activities.
- This was followed by the request to the Federal Council from the NES Therapeutic Products Division. In April 2023, the Federal Council approved the start of a preliminary study on the implementation proposal to expand the reporting requirements, and the necessary digitalisation of the reporting process, as well as the provision of the requisite resources.
- This decision concluded the assignment of the first of 20 actions aimed at improving the data foundations. In a preliminary study, the NES Therapeutic Products Division is currently developing possible expansions of the digitalisation of the reporting and monitoring processes and the associated costs and resources.
- In January 2024, the Federal Council instructed the EAER to develop a high-performance, future-oriented monitoring platform for therapeutic products.
- Subproject 1 was also to focus on quantifying the economic impact of supply disruptions, which corresponds to Action 3.
- The data for quantifying the economic impact (direct and indirect costs) of supply disruptions for human medicines was collected through a survey of all the relevant stakeholders in the public administration, the industry and the service providers. The year 2022 was taken as the reference year for the data collected. The economic impact of supply disruptions for Switzerland is put at some CHF 240–500 million per year. A great deal of uncertainty is attached to the quantification results, however, since it is not currently possible to reliably measure the annual costs of supply disruptions for Switzerland due to a lack of sufficiently structured data.
Subprojects 2 to 8
- The subprojects 2 and 3 as well as 5 to 8 are centred on actions relating to the clarification of the roles of various stakeholders, the storage, the market access, possible incentives and the Confederation’s own production and/or procurement of essential medicinal products. These issues are addressed in Actions 5-18.
- In addition to clarifying responsibilities, a stronger international network is crucial. This is addressed in Subproject 4 and by action 19. The prime focus is on considering a close collaboration with internationally relevant parties such as the European Union (EU). At the same time, however, collaborations and a cooperation with the EU must be viewed in the overall context of Swiss-EU bilateral relations.
- The Federal Council took the following decisions on 21 August 2024:
- Working with the EAER and the DDPS, the FDHA is to examine the provisions governing the division of tasks and the different competencies and responsibilities within the federal administration. In addition, the legal foundations are to be examined, together with the amendments required with a view to possibly expanding the competencies of the Confederation.
- The stockpiling obligation is to be extended to additional medicines. The EAER is instructed to draw up a basis for decision-making that can be applied when determining how the reporting and stockpiling obligation for medicines can be further improved and the expansion of compulsory stocks can be funded.
- When it comes to market access for essential medicines, the TPA is to be amended in such a way as to permit medicines that are not authorised in Switzerland to be imported for larger patient groups on a temporary basis so as to combat supply disruptions. In addition, the further optimisation of simplified approval procedures and Switzerland's participation in European approval processes are to be closely examined in a bid to increase Switzerland's market attractiveness for off-patent drugs.
- Manufacturers of medicines that are crucial for ensuring supply are to be offered incentives to continue producing these medicines in future. Market withdrawals on grounds of profitability are to be avoided through potentially waiving cost-effectiveness reviews for medicines on the specialities list which are of relevance to supply and meet certain criteria and also through the publication of a fact sheet on applications for price increases. It is also to be examined whether remuneration, or authorisation, can be more closely linked to a guarantee of security of supply.
- Statutory provisions are to be amended in such a way that the Confederation can conclude capacity contracts with a manufacturer in order to avoid supply disruptions for individual medicines and/or so that it is possible for the Confederation (represented by the Armed Forces Pharmacy) to dispense its own products in the event of severe shortages.
- In addition, it is to be possible for medicines, active substances and medical devices to be exempt from the WTO tendering obligation in future.
- Switzerland is to work at international level towards ensuring that global supply and value chains become safer and more resilient and that conditions are created to promote the optimum supply of medicines.
Strategy for securing vaccine supplies
The actions designed to ensure the long-term promotion of vaccine research, development and production are being pursued in a separate project, and are the 20th action from the FOPH’s Disruptions of Supplies Report of 2022 (Boosting vaccine research and manufacture).
Frequently Asked Questions (FAQ)
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Last modification 22.08.2024
Contact
Federal Office of Public Health FOPH
Health Protection Directorate
Competence center for supply security
Schwarzenburgstrasse 157
3003
Bern
Switzerland