Compassionate use in Switzerland and individual import under Art. 49 MPLO

What compassionate use covers in Swiss law

Compassionate use in Switzerland is a temporary authorisation to use medicinal products outside clinical trials, granted on the basis of Art. 9b para. 1 of the Therapeutic Products Act. It addresses patients who are being treated with a product that has been successfully tested in clinical trials but is not yet authorised.

The wording matters for planning. The route presupposes a clinical trial programme that has produced successful results, so it is a bridge between the end of a trial and the authorisation decision rather than a substitute for either.

Individual import under Art. 49 MPLO

The second and much more frequently used instrument is individual import. Under Art. 49 of the Medicinal Products Licensing Ordinance, healthcare professionals with dispensing authority may import small quantities of ready-to-use medicinal products that are not authorised in Switzerland, without a licence, provided the conditions of Art. 49 paras. 1 to 4 MPLO are met.

• The importer must be a healthcare professional with dispensing authority.
• Only small quantities of ready-to-use medicinal products are covered.
• The product must be one that is not authorised in Switzerland.
• No import licence is required when the conditions of Art. 49 paras. 1 to 4 MPLO are satisfied.

The instrument is built for the single patient in front of a clinician, not for supply. Quantities are small by definition, so an individual import cannot substitute for an authorisation where a product is needed continuously for a cohort of patients.

The professional's own responsibility

Individual import shifts responsibility onto the importing professional. There is no authority decision to rely on, so the professional must verify that the requirements are met and must keep records, as provided in Art. 49 paras. 5 and 6 MPLO. Documentation is part of the legal basis of the import, not an afterthought.

1. Establish that no authorised alternative makes the import unnecessary and that the case falls within Art. 49 MPLO.
2. Verify that the conditions of Art. 49 paras. 1 to 4 MPLO are met, as required by Art. 49 para. 5 MPLO.
3. Import the small quantity of the ready-to-use medicinal product.
4. Keep records of the import, as required by Art. 49 para. 6 MPLO.
5. Handle reimbursement separately, through a cost approval request under Art. 71a to 71d KVV where applicable.

Records under Art. 49 para. 6 MPLO are what makes the import defensible after the fact. They identify the product, the quantity and the patient context, and they are the only evidence that the conditions of Art. 49 paras. 1 to 4 MPLO were verified beforehand.

Boundaries with clinical trials and authorisation

The three regimes answer different questions and should not be blended. A clinical trial generates data under a protocol. Compassionate use under Art. 9b para. 1 TPA lets treatment continue outside a trial for a product successfully tested in trials but not yet authorised. An authorisation, temporary or ordinary, makes the product marketable in Switzerland.

• Clinical trial: data generation under a protocol, with trial-specific approvals.
• Compassionate use under Art. 9b para. 1 TPA: temporary use outside trials, for a product successfully tested in trials and not yet authorised.
• Individual import under Art. 49 MPLO: small quantities of an unauthorised ready-to-use medicine, imported by a professional on their own responsibility.
• Temporary authorisation under Art. 9a TPA: a limited-term authorisation with conditions, assessed against cumulative criteria.

Mixing the regimes creates avoidable exposure. A product supplied under Art. 49 MPLO is not a trial medication, and continuing treatment after a trial closes is a question for Art. 9b para. 1 TPA rather than for the trial protocol.

How reimbursement interacts with these routes

Access and payment are decided separately. Neither compassionate use nor an individual import creates an entitlement against compulsory health insurance. Reimbursement outside the specialities list runs through Art. 71a to 71d KVV, where costs are covered only after special approval by the insurer following prior consultation of its medical adviser.

A further consequence is that neither route creates a market. Neither instrument establishes a Swiss authorisation, a product information in the three official languages or an entitlement against compulsory health insurance, so neither removes the need for an authorisation strategy.

For an unauthorised product the relevant constellation is the third one: a medicine not authorised by Swissmedic but imported from a country with an authorisation system recognised as equivalent by Swissmedic and authorised there for the indication concerned. The insurer decides within two weeks of a complete request for cost approval.

Practical consequences for companies and hospitals

For a company, these routes are neither a market nor a substitute for an authorisation strategy. For a hospital, they are a regulated exception with documentation duties attached. Both sides benefit from settling in advance who verifies the conditions, who keeps the records and who prepares the cost approval request.

• Clarify before first use which instrument applies: Art. 9b para. 1 TPA, Art. 49 MPLO or a temporary authorisation under Art. 9a TPA.
• Assign the verification and record-keeping duties of Art. 49 paras. 5 and 6 MPLO to a named role.
• Prepare the clinical justification for the cost approval request in parallel, not after treatment has started.
• Track whether an authorised alternative has become available in Switzerland, since that changes the analysis.

For companies there is a further boundary to respect. Information about a product that is not authorised in Switzerland is not promotional material, and communication around compassionate use or individual imports should stay factual and responsive rather than anticipatory.