To obtain a licence, the head of the institution must submit a written request to the FOPH and:
- Certify that the institution holds a cantonal licence (Article 3e, paragraph 1 NarcA). A copy of the licence must be enclosed with the request.
- Specify the envisaged duration of the licence (no more than five years). (NB: the federal licence is issued for a maximum duration equivalent to that of the cantonal licence. If the cantonal licence is revoked or expires, the federal licence will automatically be rendered null and void).
- Ensure the provision of interdisciplinary treatment and care (Article 14 NarcAO), providing evidence in the request that:
- The team includes persons with a range of competences (physicians, nursing staff, social workers, psychologists).
- Each physician prescribing diacetylmorphine holds an FOPH licence.
- The staff is qualified and regularly participates in further training.
- A care concept and treatment protocol exist for the diacetylmorphine (guidelines concerning dosage, form of application, combination with other opioids, etc.).
- A treatment agreement is available. The FOPH can provide a sample agreement that can be adapted to the specific situation of the centre.
- Have a sufficient number of healthcare staff available (Article15 NarcAO), i.e.:
- At least one physician licensed to prescribe diacetylmorphine (1.7 percent of a post per patient).
- Social workers (1.7 percent of a post per patient).
- Nursing staff / persons responsible for delivering treatment. If the treatment delivery room has five injection bays, two members of staff must be present for each work period. If there are more than five bays, three staff must be present, at least one of whom must be a health professional.
- Have the appropriate infrastructure, especially:
- A plan and photographs of the premises.
- Security measures and emergency procedures.
- Civil liability insurance for the institution and the physicians.
- Internal regulations.
- Quality certificates, if applicable (e.g. ISO or QuaTheDa).
- Measures guaranteeing data protection (Article 3f NarcA in conjunction with Article 41ss NarcAO).
- Guarantee the safety and quality of diacetylmorphine use (Article 51, paragraphs 2 and 54 of the Narcotics Control Ordinance, OCNarc), in particular:
- Theft-proof storage of the diacetylmorphine.
- Documentation of diacetylmorphine use, especially orders, internal organisation, delivery control, etc.
- Participate in the monitoring programme for diacetylmorphine-assisted treatment (“HeGeBe” monitoring) run by M. Gerard Gmel (e-mail ggmel@addictionsuisse.ch, Addiction Suisse, Lausanne).
No fee is charged for the licence issued to the institution (Article 40, letter d NarcAO).
The request must be addressed to
Federal Office of Public Health
Prevention Non-communicable Diseases Division
Schwarzenburgstrasse 157
3003 Berne
Switzerland
Tel: 058 463 20 43
