Security in the supply of medicines

The supply of medicines in Switzerland cannot be assured in all cases. Despite action already being taken, there has not yet been an improvement. 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:

The vertical flowchart illustrates the medicine supply chain, whose 12 steps run from top to bottom. Each step and its icon follows the other: a) Key starting materials (KSMs), b) Active pharmaceutical ingredients (APIs), c) Excipients, d) Packaging, e) The final product, f) Fill & finish, g) Approval, h) Pricing, i) Logistics, j) Wholesale, k) Pharmacies, hospitals and doctors’ practices (all the same step) and l) Patients.   The flowchart also features the numbers 1 to 8, which each stand for a possible cause of supply chain disruption, and whose placement in the chain indicates where this may occur. These causes are described at length on the webpage after the flowchart illustration. Cause 1 has an impact throughout the supply chain. Causes 2 and 3 can extend over the first three supply chain steps of KSMs, APIs and Excipients. Causes 4 and 5 may extend over the first six supply chain steps, up to and including Fill & finish. Cause 6 relates to the Approval step, Cause 7 applies to Pricing and Cause 8 relates to the Patients.  This presentation permits a more detailed examination of what may cause disruptions to supplies at the various stages along the medicine supply chain.

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.

The vertical diagram presents a timeline from 2006 to today, along which are marked the key milestones reached by the Swiss Confederation in securing medicine supplies. The timeline highlights eight years in which such major progress was achieved. The milestones concerned are presented chronologically and in greater detail in the accompanying text.

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. The results of this preliminary study are expected in early 2024.

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.

This diagram illustrates the structure of a project that has been subdivided into a number of subprojects. The project consists of eight subprojects in all, plus a further stand-alone element.  The diagram further distinguishes four main topic areas, which are shown in different colours:  Topic Area Pink: International networking, covered by Subproject 4.  Topic Area Purple: Domestic actions, covered by four subprojects: Subproject 7 covers the storage and stockpiling of essential medicines. Subproject 6 is concerned with incentives for manufacturers of essential medicines. Subproject 5 is concerned with market access for essential medicines.  Subproject 8 covers the issue of public procurement and production.  Topic Area Dark Green: The roles of the various stakeholders, which are covered by Subprojects 2 and 3. These two subprojects can be combined.  Topic Area Light Green: Monitoring and analysing supply disruptions, which is covered by Subproject 1.  The project’s Action 20, which calls for the long-term promotion of vaccine research, development and production, has been placed in a separate ‘Strategy for securing vaccine supplies’.

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. The results are to be re-submitted to the Federal Council at the beginning of 2024.
  • The main activities at present in Subproject 1 are focused on quantifying the economic impact of supply disruptions, as is specified in Action 3.

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.
  • A decision by the Federal Council on the implementation proposals for these subprojects is expected mid-2024.

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).

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Last modification 05.04.2024

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Federal Office of Public Health FOPH
Division of Biomedicine
Therapeutic Products Law Section
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