By decision of November 7 2012 (officially published on January 15, 2013), the Swiss Federal Government submitted a proposal for an amendment to the Swiss Federal Law on Medicinal Products and Medical Devices (Law on Therapeutic Products) to the Swiss Parliament.
The amendment proposes to simplify the process for granting marketing authorisations for (i) synthetic pharmaceuticals that have been produced according to specific therapies like homeopathy, anthroposophy or Asiatic medicine and that are applied in line with the principles of this therapy and (ii) for pharmaceuticals that treat live endangering diseases or which might trigger a permanent disability, if no alternative and equivalent pharmaceutical having a Swiss marketing authorisation exists. Swissmedic (the Swiss marketing authorisation body) shall also be given the right to allow the import of pharmaceuticals that were already marketed abroad in countries with a similar control of pharmaceuticals for a limited period of time or in limited quantities if no similar pharmaceutical is available in Switzerland.
The amendment shall also improve pharmacovigilance and will require that, when applying for a marketing authorisation for a specific pharmaceutical, a paediatric trial plan be filed that shows the requirements for the development of the pharmaceutical in paediatrics.
However, the most important change relates to the grant of pecuniary advantages to healthcare professionals. Currently, the law prohibits the grant, offer or promise of material benefits to persons who prescribe or supply medicinal products and to the organisations that employ them, but allows material benefits of modest value that are of importance to medical or pharmaceutical practice as well as commercially and economically justified discounts which directly reflect on the price. The interpretation of this prohibition (and its exceptions) has been highly disputed and to date there have been hardly any convictions.
The proposed amendment shall now prohibit the offer, promise or grant of pecuniary advantages to persons who prescribe pharmaceuticals that are only available on prescription as well as to organisations that employ such persons, provided that such advantages are able to influence these persons in these activities.
Pecuniary advantages of modest value that are relevant to the recipient's medical or pharmaceutical practice remain allowed. Equally allowed is the grant of rebates and discounts provided that they are shown in the invoices and in the books of the sellers, purchasers and organisations and are passed on to patients or their insurers.
The suggested amendment shall also increase transparency. It requires persons who prescribe, sell or apply pharmaceuticals and organisations that employ them to inform their customers as to (i) any participation they have in undertakings which manufacture or put to market pharmaceuticals, (ii) any activity in management boards, supervisory boards, advisory boards or similar bodies of such undertakings as well as any consulting or expert activity for such undertakings, and (iii) any participation that such undertakings hold in their own medical or pharmaceutical practice or organisation.
Furthermore, the enforcement of the rules on the grant of pecuniary advantages to healthcare professionals shall no longer be enforced by Swissmedic but by the Federal Office for Public Health. This change will likely increase the number of cases that will be investigated and ultimately might be prosecuted.
The proposal will now have to be discussed by the two chambers of parliament and, once finally adopted, might be subject to a referendum.