Background to the suspensions in October 2019
On 1 October 2019, Swissmedic decided to suspend the establishment licences and all medicinal product authorisations of Amino AG and Dr. Heinz Welti AG following the disclosure that the company owner (who was simultaneously the Responsible Person) had been convicted in a court of first instance of breaches of the Narcotics Act and the Chemicals Act (appeal proceedings were pending at that time). Since repeated efforts by Swissmedic to have the companies each appoint a new, trustworthy Responsible Person (RP) proved unsuccessful, Swissmedic eventually suspended the establishment licences and authorisations of both companies. However, in the interests of security of supply, Swissmedic waived a recall of the medicinal products already sold by the companies. Amino AG and Dr. Heinz Welti AG subsequently appealed against the official decisions of suspension. Although the suspensive effect of these proceedings meant that the companies could continue to carry out their activities covered by the licences, they were also required, under the jurisdiction of the court, to request the approval of a valid new RP without delay in order to be able to continue their manufacturing and distribution operations.
The Swiss Federal Supreme Court issued a final rejection of these appeals on 29 November 2022 (published 7 December 2022) and thus considered Swissmedic's official decision to be correct. The findings of the criminal investigations were sufficient to raise doubts about the trustworthiness of the RP.
Important role of the Responsible Person
Anyone who manufactures or distributes medicinal products is required by therapeutic products legislation to apply to Swissmedic for an establishment licence. The licence is granted if the company concerned can demonstrate, in connection with an inspection, that it complies with the international quality standards pertaining to manufacture and distribution, and if it has appointed a sufficiently qualified and trustworthy RP.
From the standpoint of therapeutic products legislation, the RP plays the most important role in a company. In fact, the RP is responsible for directly supervising the facilities, taking all the measures needed to protect patients and for ensuring compliance with the provisions of therapeutic products legislation. He or she is responsible for the quality of the medicinal products manufactured in the facilities and releases the manufactured batches for placing on the market.
As the Federal Administrative Court and the Federal Supreme Court had repeatedly confirmed in earlier rulings, and as reinforced by this ruling, the trustworthiness of the RP is vitally important. If this trustworthiness no longer applies, the quality and safety of the medicinal products manufactured and distributed under their supervision are jeopardised.
A change of RP must be requested by a company as a variation of the establishment licence and may be implemented only after the new licence has been approved and issued. Swissmedic is responsible for checking the professional qualifications and trustworthiness of every RP and also for ensuring that the percentage of FTE hours worked by an RP is sufficient for guaranteeing, at all times, the direct supervision of compliance with the obligations arising from therapeutic products legislation. Because of their aforementioned key role, the application for any new RP is evaluated carefully according to legally defined criteria.
Similar rules are also included in narcotics legislation.
Sustainable improvements required
The ruling of the Federal Supreme Court means that Swissmedic's decision of 19 October 2019 is now legally enforceable. The suspensions of the establishment licences and authorisations of Amino AG and Dr. Heinz Welti AG will continue to apply until the deficiencies are remedied and Swissmedic is able to lift the suspension. As reported by various media sources, the companies have applied to Swissmedic for a new RP following the ruling of the Federal Supreme Court. Swissmedic has not approved these applications to date. Official secrecy prevents Swissmedic from commenting on statements made by the company owner and reported in the media. As soon as the companies are able to demonstrate that they can once again guarantee conformity with the provisions of therapeutic products legislation, Swissmedic will lift the suspension. Swissmedic has clearly explained to the companies the relevant requirements needed to remedy the deficiencies.
In view of the criminal proceedings, the deficiencies of the existing RP that resulted in the suspension are serious. For more than three years, both companies have known that, under the jurisdiction of the court, they were required immediately to appoint a competent and trustworthy new RP in order to prevent a possible supply bottleneck. However, the companies were unwilling to appoint a new RP, hence the prevailing risk of supply shortages.
Options offered by therapeutic products legislation for overcoming supply shortages
The companies affected by the suspension are not the only manufacturers of these important medicinal products. Therapeutic products legislation offers various options that companies, hospitals, pharmacies or doctors can use for ensuring that patients can still be supplied with these medicines. Companies can apply for the authorisation of comparable medicinal products or the extension of existing authorisations (e.g. with new dosage strengths or new dosage forms). Swissmedic will review such applications as a matter of priority given the current situation. Dispensers of medicines, such as hospital or community-based pharmacies, have the option of manufacturing corresponding preparations for their own customers or as subcontractors. The modalities for manufacturing what are known as "formula-related" medicinal products are described in Art. 9 para. 2 let. a-cbis TPA. Moreover, healthcare professionals (e.g. doctors or pharmacists) have the option of importing medicinal products authorised in Germany or other EU countries in small quantities for their own patients if no alternatively usable product authorised in Switzerland is available. This is regulated in Art. 49 MPLO. Since a narcotic is involved in this case, the requirements of narcotics legislation also need to be observed. This means that an import licence would be needed. Swissmedic processes such applications from healthcare professionals within 1 or 2 days.
Security of supply
Ensuring that Switzerland is supplied with essential goods and services is primarily a matter for the private sector. National Economic Supply (NES) measures are always implemented as a back-up only. Based on National Economic Supply legislation, the NES can actively intervene only if the private sector is no longer able to fulfil its supply remit and if operationally capable companies still exist in Switzerland. For reasons relating to therapeutic products legislation for example, the NES is unable to order a quota of a product from another country. Mandatory stockpiles are always the property of the corresponding companies and are maintained on the basis of a stockpiling mandate issued by the Federal Council.
The NES is being kept updated by Swissmedic about the suspension of the establishment licences and authorisations of Amino AG/Dr. Heinz Welti AG. The NES is in contact with other agencies, hospitals and companies and helps them find solutions to overcome current supply shortages in the therapeutic products sector. For example, the NES regularly publishes overviews of the current supply shortages in the therapeutic products sector and also lists any proposals for action and measures implemented by the Swiss government (see: Aktuelle Versorgungsstörungen (admin.ch)).