Why Can’t Some Patients in Switzerland Access New Medicines?
Switzerland’s healthcare system is world-class, yet access to new medicines is not automatic. An overview of listing procedures, equitable reimbursement and what Hungarian patients need to do.
What does access to innovative medicines mean in Switzerland?
Here, “access” does not refer to medical expertise or the quality of hospital care, but to whether a particular medicine can actually be prescribed and whether its cost is covered by insurance.
In Switzerland, this is divided into several distinct stages:
Authorisation (Arzneimittelzulassung): Swissmedic assesses the medicine’s safety and efficacy and decides whether it may be placed on the market.
Listing and reimbursement: the Federal Office of Public Health (Bundesamt für Gesundheit, BAG) decides whether the product is added to the specialities list (Spezialitätenliste, SL)—the list of medicines reimbursed by compulsory basic health insurance.
The two steps do not take place simultaneously. A medicine may be authorised in Switzerland but not yet appear on the reimbursement list. In such cases, the patient may in principle obtain the medicine, but its cost is not necessarily covered by basic insurance.
What is the Spezialitätenliste, and why does it matter?
The specialities list (Spezialitätenliste, SL) is the official list that determines which medicines compulsory basic health insurance (OKP) reimburses and at what price. The legal framework is provided by the Health Insurance Ordinance (Krankenversicherungsverordnung, KVV).
The practical consequence is straightforward: if a medicine is not on the list, basic insurance generally does not cover its cost.
Before listing, BAG and the manufacturer negotiate the medicine’s price and the conditions for reimbursement—for example through industry representative organisations, including companies that are members of Interpharma. Until this process is concluded, the patient’s situation may remain uncertain.
This mechanism explains why there can appear to be a gap between the system’s overall quality and the availability of individual new medicines: the standard of clinical care is high, but the financing decision is a separate administrative and price-negotiation process.
Why can availability differ from the standard of the system?
The main reason for this discrepancy is that authorisation is a medical and scientific matter, whereas reimbursement is a matter of price and budgeting.
Several factors can delay or complicate access:
Price negotiations: the manufacturer and the authorities may consider different prices acceptable, and reaching agreement can take time.
International pricing considerations: medicine prices are determined in a global market. International pricing mechanisms—including debates surrounding approaches based on the Most-Favored-Nation-Regime (MFN)—may influence the price at which, and the time when, a manufacturer enters a particular market.
Timing of the listing decision: time passes between authorisation and inclusion on the list.
Several organizations monitor European comparisons. For example, the EFPIA pharmaceutical industry association’s Patients W.A.I.T. Indicator examines how long it takes for newly approved medicines to become available in individual European countries and what proportion of them become available. The purpose of such indicators is precisely to make differences in access between countries visible.
What happens if a medicine is not on the list? — individual reimbursement on a case-by-case basis
If a medicine is not included in the specialities list, or is not listed for the indication in question, an individual assessment procedure is available.
This is governed by Articles 71a–71d of the Health Insurance Ordinance (KVV). This is known as individual reimbursement on a case-by-case basis (Einzelfallvergütung, Art. 71a–d KVV).
The key points are:
Based on the treating physician’s justification, the patient individual assessment may be requested from their insurer.
The insurer (or its medical expert) decides whether to cover the costs in the individual case.
The decision is made on a case-by-case basis, so it is not guaranteed, and the process may take time.
This procedure is an important safety net, but it does not replace regular listing. The outcome is uncertain, and patients often have to submit medical and administrative documentation.
Why are medicine prices and listing rules not determined at cantonal level?
Many things in Switzerland vary from canton to canton — taxes, health insurance premiums and the school system, for example. The listing and pricing of medicines, however, are not cantonal matters.
Reimbursement of medicines under compulsory basic insurance is regulated uniformly at federal level. The BAG manages the specialities list and its associated prices, which are the same throughout Switzerland.
This is a useful simplification for Hungarian readers: whether basic insurance reimburses a particular medicine generally has nothing to do with which canton the patient lives in. Insurance premiums vary by canton and insurer, but the range of medicines covered by basic insurance is uniform throughout Switzerland.
What debate surrounds the review of the regulations?
Access to medicines is regularly the subject of political and professional debate in Switzerland. The planned amendments to the KVV — including a review of reimbursement and pricing rules — have divided the stakeholders involved.
On one side, patient organizations and the industry are calling for faster, more predictable access. On the other is the need to keep the system financially sustainable and insurance premiums under control.
The exact rules may change, so for specific procedural questions, the applicable official sources (BAG, Fedlex) should always be regarded as authoritative.
What should Hungarian patients living in Switzerland know?
Coverage of medicines under basic insurance applies uniformly to everyone insured in Switzerland, regardless of nationality. As a Hungarian citizen, you have access under compulsory basic insurance to the same listed medicines as anyone else.
A few practical considerations:
If a prescribed medicine turns out not to be on the list, it is advisable to clarify the possibility of reimbursement with the treating physician and the insurer , including the possibility of an individual assessment under Art. 71a–d KVV.
For access-related questions, supplementary insurance (Zusatzversicherung) may offer different terms from basic insurance — this should be checked separately.
If there are language difficulties, it may be helpful to involve a healthcare professional who also speaks Hungarian, particularly in complex treatments.
It is important to maintain realistic expectations: a high standard at the system level does not mean that every newly approved medicine is immediately and automatically available.
Sources and limitations of the topic
This article outlines the general logic of the access process: the distinction between approval and reimbursement, the role of listing, and the possibility of an individual assessment.
Specific figures — such as how many medicines are not included on the list, how long the waiting period is, or the status of a particular product — change over time and should always be verified using the current official data source.
This material does not provide answers for individual medical situations. The treating physician and the insurer can always provide precise information together about reimbursement for a specific medicine.
Sources
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In Brief
Swiss approval of a new medicine does not automatically mean that it is covered by compulsory basic health insurance. Coverage depends on the Specialties List administered by the BAG; if the medicine is not listed, an individual assessment may be requested, but its outcome is not guaranteed.
Key Takeaways
- Swissmedic marketing authorisation and the decision on reimbursement by basic insurance are two separate processes.
- The BAG’s Specialties List determines which medicines compulsory basic health insurance covers and at what price.
- Listing may be delayed by price negotiations and discussions concerning the conditions of reimbursement.
- For a medicine that is not listed, or not listed for the relevant indication, an individual assessment may be requested, but reimbursement is not automatic.
- Listing and pricing rules are set at federal level, so the range of medicines covered by basic insurance is uniform throughout Switzerland.
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