Revision of the Therapeutic Products Act and the Ordinance on Medicinal Products

Health Law, Life Science

The partial revision of the Therapeutic Products Act ("HMG") and the Ordinance on Medicinal Products ("VAM"), which came into force on 1 January 2019, also includes provisions for the reclassification of medicinal products into the various categories. This reallocation is intended to facilitate patients' self-medication and make better use of the expertise of drug dispensing centres (pharmacies and drugstores).

What does the partial revision of the tax categories mean?

The Swiss Agency for Therapeutic Products (Swissmedic) has already started implementation. In the first half of 2019, the authority will make the individual reallocation decisions as well as the preliminary notifications and orders to the authorisation holders concerned in the ordinary administrative procedure.

The allocation of medicinal products from category C to categories B or D, which has been deleted without substitution, will take place in the first quarter of the current year. Due to the large number of patients, these procedures are opened in groups of about 100 per week, ordered by therapeutic area. For the second quarter of the year, it is planned to reallocate individual drugs from the D category to the E category. Approximately 15 per cent of the 450 or so products evaluated will be affected.

By the autumn of 2019, all the ordered reallocations are to be legally binding. Swissmedic may, however, postpone the effective date of the reclassification at the request of the authorisation holder concerned. However, Swissmedic can only delay the granting of an authorisation for a period of three to a maximum of six months in order not to favour any authorisation holder excessively over competitors.

What effects does the reallocation have on the practice of pharmacists?

Pharmacists can now supply the following medicines in category B without a doctor's prescription:

  • "higher tiered" medicines of the former category C (these medicines may now also be supplied without a doctor's prescription);
  • Medicinal products for the treatment of frequently occurring diseases (in so far as they are medicinal products containing known active substances which have been authorised for several years);
  • Medicinal product for the continuation of a permanent medication (for one year after initial prescription by a doctor).

In addition to pharmacists, druggists can now also dispense certain medicines of category D from the old category C after specialist advice from a medical person:

  • "lower tiered" medicines of the former category C (these medicines may now be supplied after mere professional advice from a doctor, pharmacist or other medical person);
  • In future, drugstores will be able to supply all medicines without a prescription.

In addition to pharmacists, druggists can now also dispense certain medicines of category E from the old category D without specialist advice from a medical person:

  • "lower tiered" medicines of the former category D (these medicines may now also be supplied without specialist advice from a doctor, pharmacist or other medical person);
  • In future, all businesses will be able to sell medicines for self-medication.

The reallocation may affect the permitted forms of advertising of medicinal products, in particular for medicinal products that have been reallocated from category C to category B. The reallocation may have an impact on the forms of advertising that are permitted. For prescription drugs, public advertising, i.e. advertising to consumers or the general public, is generally prohibited (cf. Art. 32 para. 2 lit. a HMG and Art. 14 AWV).

It is not only forbidden to advertise prescription medicines in categories A and B - and thus also the new preparations assigned to category C - by means of additional measures (e.g. cardboard displays with pictures or words). In future, these medicines will no longer be allowed to be displayed freely in the salesroom (e.g. no visible choice on shelves behind the counter), but must be stored in areas of the pharmacy that cannot be seen (e.g. in drawers or "back stage"). Patients are therefore no longer allowed to see the new drugs classified as B, as they could be "invited" to buy or use them. Such a visible placement is already considered as (prohibited) public advertising for prescription-only medicines.

The pharmacies must deal promptly with the drug reallocations, in order to arrange the publicly accessible and/or visible ranges of the retail shop and the presentation of the Pharmaprodukte further right-conformal and not (unconsciously) against the law regulations over the medicament advertisement to offend. This is because administrative and criminal sanctions, including heavy fines, may be imposed in the event of infringements. For prevention purposes, pharmacy owners should ask the individual authorisation holders which medicines are affected by the reallocation and from when these new listings will apply.

We will be happy to advise you on all questions relating to drug advertising and support you in the implementation of your marketing strategy with a view to the current partial revision of drug law.

January 2019 | Authors: Dr. Juana Vasella, Dr. Jonatan Baier, Sophie Schmid

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