Health policy issues

  • Drug approvals
  • Cost approvals of services
  • Approval of medicines
  • Inclusion of patient expertise in health policy discussions
  • Involvement of patient expertise with regulatory authorities

Which organizations and institutions are involved?

  • Federal Office of Public Health (FOPH)
  • Swissmedic
  • Pharmaceutical companies
  • Health insurers
  • Disability insurers
  • Service providers

In which direction should health policy develop?

The medicine of the future will only succeed if health policy shifts from a discussion ABOUT patients to a discussion WITH patients.

Patient involvement in drug approval planning

Once Phase III drug testing is complete, the manufacturer of the active ingredient can apply to Swissmedic for approval. After Swissmedic has gone through a very strict assessment procedure, it can authorize the drug, which does not yet mean that the costs of the drug must be covered by the basic health insurance. The Federal Office of Public Health (FOPH) decides on the inclusion in the compulsory health insurance scheme and assesses the efficacy, suitability, and cost-effectiveness of the drug (criteria laid down in the Health Insurance Act).

Patient involvement in pricing

The Federal Office of Public Health (FOPH) sets a maximum price for medicines that are on the specialty list (i.e., that have passed the approval process by Swissmedic and the FOPH). Only medicines prescribed by a doctor must be covered by compulsory health insurance. Every three years, all medicines included in the list of specialties are reviewed with regard to effectiveness, appropriateness, and cost-effectiveness. This usually results in a price reduction.

Patient involvement in cost approvals

According to Articles 71a to 71d of the Ordinance dated 27 June 1995 on Health Insurance (KVV), the compulsory health insurance (OKP) reimburses medicines in individual cases if:

  • which are listed on the SL, but are dispensed outside the Swissmedic-approved SmPC or SL-limitation

  • which are not included in the SL but are authorized by Swissmedic

  • which are not authorized by Swissmedic but are imported from a country with an authorization system recognized as equivalent by Swissmedic and are authorized there for the corresponding indication

  • If the use of a medicinal product forms an indispensable prerequisite for the performance of another compulsory service covered by the OKP and if this is clearly the main focus, the OKP will also cover the medicinal product even though it is not listed in the SL (so-called treatment complex).

  • If there is no treatment complex, then for the reimbursement of a medicinal product in an individual case by the OKP, the use of the medicinal product is expected to have a major therapeutic benefit against a disease that can be fatal for the insured person or cause severe and chronic health impairments, and due to a lack of alternatives, no other effective and authorized treatment method listed in the SL is available.
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