Switzerland issues new regulations to ensure national health care during the COVID 19 epidemic – The impact on the Life Sciences sector

Authorization required for the export of certain medical products

The new amendment to the COVID-19 Ordinance 2 defines certain medical products and medical protective equipment that can only be exported out of Switzerland with an authorization by the State Secretariat for Economic Affairs (SECO). This new authorization is required in addition to any authorizations needed under the Therapeutic Products Act or the Narcotics Act that would also be required in a normal situation.

The goods concerned are listed in Annex 3 of the COVID-19 Ordinance 2 and include protective glasses and visors, face masks, protective gloves, protective clothing as well as pharmaceuticals with the following five active substances: propofol, midazolam, rocuronium bromide, atracurium besilate and cisatracurium.

Propofol is an anesthetic/narcotic also used for patients who are connected to ventilators. Swiss marketing authorizations for propofol products have been granted for example to Aspen Pharma Schweiz GmbH (Disoprivan), B. Braun Medical AG (Propofol-Lipuro), Fresenius Kabi (Schweiz) AG (Propofol MCT Fresenius) and Primex Pharmaceuticals AG (Recofol).

Midazolam is hypnotic agent also administered in case of respiratory distress. Swiss marketing authorizations for the hypnotic indication of midazolam have been granted inter alia to CPS Cito Pharma Services GmbH (Dormicum), Sintetica SA (Midazolam Sintetica) and Accord Healthcare AG (Midazolam Accord).

Rocuronium bromide is a muscle relaxant used in modern anesthesia to facilitate tracheal intubation by providing skeletal muscle relaxation, most commonly required for surgery or mechanical ventilation. Swiss marketing authorizations are held for example by MSD Merck Sharp & Dohme AG (Esmeron), Fresenius Kabi (Schweiz) AG (Rocuronium Fresenius) and Labatec Pharma SA (Rocuronium Labatec).

Atracurium besilate is also a muscle relaxant. Swiss marketing authorizations have been granted to Aspen Pharma Schweiz GmbH (Tracrium).

Cisatracurium might be used for patients with COVID-19 who require endotracheal intubation, if there is considerable dyssynchrony with positive pressure ventilation, accompanied by increased plateau airway pressures and refractory hypoxaemia. Swiss marketing authorizations have been granted to Aspen Pharma Schweiz GmbH (Nimbex).

In recent days, there have been repeated reports (see for example here, here, and here) that there are global bottlenecks in the supply of medicines, in particular concerning pharmaceuticals containing the aforementioned active ingredients.

There are some exceptions to the requirement of an authorization for the export of those pharmaceuticals and medical products. In particular, the export is still permissible without an authorization to EU and EFTA member states, to the UK as well as to some other smaller countries (Faroe Islands, Andorra, San Marino and the Vatican) insofar as any of the listed countries grant reciprocity. Further exceptions include the export of equipment for first aid, of goods for personal use as well as the export of goods intended for the supply of Swiss diplomatic missions abroad.

Companies wishing to export medical supplies that are subject to an authorization requirement can submit their application for an authorization to the SECO over the electronic authorization platform “ELIC“. Usually the SECO will decide on the grant of an authorization within five working days. In complex cases, the deadline can be extended for another five working days. The decision is issued electronically.

The SECO grants the authorization for the export of the aforementioned goods if the need for such goods of Swiss health facilities, medical workers, patients, the military and other authorities and institutions providing health care services in Switzerland is covered. The decision to grant an authorization is taken by the SECO considering the opinions of various Swiss authorities, such as the Federal Office of Public Health (FOPH).

Notification obligation regarding the stock of certain pharmaceuticals and medical devices

The amendment to the COVID-19 Ordinance 2 also introduces a notification requirement for essential pharmaceuticals and medical devices including protective equipment to combat COVID-19 (so-called important medical supplies). The concerned goods are listed in Annex 4 of the COVID-19 Ordinance 2 and include pharmaceuticals with various active substances, such as virostatic agents, immunosuppressants, anesthetics, opioids, muscle relaxants, blood thinners, insulin, antibiotics, vaccines against influenza and medical gases. In addition, medical devices such as ventilators, surgical protective masks and gloves, monitoring devices for intensive care, medical oxygen and solutions for infusions are also important medical supplies. Personal protective equipment and other equipment such as disinfectants, protective masks and gloves, protective goggles, protective gear as well as hygiene articles for intensive care medicine are also addressed by the new amendment.

The Swiss Cantons are required to regularly inform the Division for Therapeutic Products of the Federal Office for National Economic Supply (Bundesamt für wirtschaftliche Landesversorgung, BWL) of the amounts of important medical supplies they have.

There is also a notification obligation for hospitals and manufacturers and suppliers of pharmaceutics. However, they only have to report the availability of the pharmaceuticals mentioned above and listed in Annex 4 part 1 of the COVID-19 Ordinance 2, but not of the medical devices and protective equipment listed in parts 2 and 3 of the same Annex.

Furthermore, laboratories, suppliers and manufacturers must notify their current stocks of in-vitro tests for COVID-19 to the National Laboratory on a regular basis.

Finally, the Swiss Coordinated Sanitary Services (Koordinierter Sanitätsdienst, KSD) has the right to enquire about current stock levels of the concerned pharmaceutics with companies storing such pharmaceutics. The Cantons must inform the KSD regularly about the stocks of the important medical supplies.

These reports of the status of important medical supplies are intended to highlight impending shortages. If necessary, the Swiss military pharmacy procures medical devices and protective equipment on behalf of the FOPH. The FOPH procures pharmaceuticals in agreement with the department for pharmaceuticals of the competent organization of the National Economic Supply.

The competent authorities may also commission third parties to procure important medical supplies.

Compulsory production and possible seizure of important medical supplies

If the supply of certain important medical supplies cannot be guaranteed in Switzerland, the Swiss Federal Department of Home Affairs (Eidgenössisches Departement für Inneres, EDI) has the right to allocate certain pharmaceutical products from other Cantons and public hospitals but is also entitled to seize important medical supplies from suppliers and manufacturers. In such cases, the authorities will compensate the purchase price paid by the suppliers or the manufacturing costs of the manufacturers.

Furthermore, the Swiss Federal Council can oblige manufacturers to produce important medical supplies or to increase the production of such medical products, if the supply in Switzerland cannot be guaranteed otherwise.

Exceptions and facilitations in the Life Sciences sector

The COVID-19 Ordinance 2 does not only provide for measures that restrict companies in the Life Sciences sector, but also stipulates certain exceptions and facilitations.

New pharmaceuticals with certain active substances can be put on the market after the filing of the application for marketing authorization with the Swiss Agency for Therapeutic Products (Swissmedic) before the marketing authorization is actually granted by Swissmedic.

Furthermore, any new indications for the treatment of COVID-19 can be implemented immediately after the respective application was submitted to Swissmedic if the following active substances are concerned: hydroxychloroquine (see the EMA information concerning hydroxychloroquine here), lopinavir/ritonavir, remdesivir (see the EMA recommendation concerning compassionate use of remdesivir) and tocilizumab.

At present, there are no authorized medicinal products for the treatment of COVID-19 or any vaccines to prevent infections with the new Coronavirus available in Switzerland. Swissmedic has therefore issued recommendations for off-label use. It is permissible to use authorized medicinal products that, in the light of initial experiences abroad, might be suitable for the treatment of COVID-19 on an off-label basis or in a clinical trial.

Hydroxychloroquine is a malaria drug currently tested in several studies. Novartis has offered to support these efforts and, if regulatory approvals are granted at the end of May, to make up to 130 million doses of this medicine available worldwide. Sanofi will also make available an antimalarial medicine containing this active ingredient.

Lopinavir/ritonavir is the subject of several WHO studies. This combination is a licensed treatment for HIV. Trials concerning lopinavir/ritonavir aim to identify and confirm any benefit for COVID-19 patients. While there are indications from laboratory experiments that this combination may be effective against COVID-19, studies done so far in COVID-19 patients have been inconclusive according to WHO.

Remdesivir was originally developed by Gilead Sciences to treat Ebola infections (against which it has not proven effective), but has shown efficacy against the Coronavirus in the laboratory. Now the drug is being tested against COVID-19 in several studies.

Roche is investigating tocilizumab in patients with COVID-19 suffering from severe pneumonia. The medicine is already approved for the treatment of rheumatoid arthritis. Chinese physicians have been testing it in severely infected patients.

With respect to the marketing approval procedure for pharmaceuticals comprising the abovementioned substances, Swissmedic may authorize deviations from the normal legal requirements.

Swissmedic also has the right to authorize the placing on the market of medical devices for which no conformity assessment procedure has been carried out in accordance with Article 10 of the Ordinance on Medical Devices (Medizinprodukteverordnung, MepV). Such authorization may be granted, if (i) the use of such medical devices for combatting the Coronavirus is in the interest of public health and safety in Switzerland and if (ii) their compliance with essential requirements as well as their efficacy is demonstrated. Such authorizations may be granted only for a limited period.

New facilitations are also in place with respect to personal protective equipment. Personal protective equipment is defined as “equipment designed and manufactured to be worn or held by a person as protection against one or more risks for their health or safety” in line with the EU Regulation 2016/425. The placing on the market of personal protective equipment is regulated by the Personal Protective Equipment Ordinance (PSA-Verordnung, PSAV) in Switzerland, which provides for conformity assessment procedures. The COVID-19 Ordinance 2 allows for deviations from those procedures for personal protective equipment such as disposable gloves, protective goggles, protective suits, disinfectants, hygienic masks, protective masks and equipment for intensive care medicine, if the use of such equipment is in the public interest for combatting and preventing the Coronavirus.

Summary

In summary, the new measures to ensure national health care during the COVID 19 epidemic decided by the Federal Council in the Life Sciences sector contain far-reaching restrictions and new obligations for suppliers and manufacturers of pharmaceuticals and medical products.

The new amendment to the COVID-19 Ordinance 2 gives the federal authorities extensive powers to intervene in the market with pharmaceuticals and medical products. Hopefully, this will not be necessary.

On the other hand, the new amendment also offers numerous simplifications and exceptions in order to research and authorize products for treating COVID-19 as quickly and easily as possible.

Inter alia, companies in the Swiss Life Sciences sector should note the following measures:

• new authorization requirement for the export of propofol, midazolam, rocuronium bromide, atracurium besilate and cisatracurium;
• new notification obligations regarding the stock of certain pharmaceuticals and medicinal products;
• the possibility of compulsory production and seizures of medical supplies, and
• certain facilitations for companies producing and marketing pharmaceutics or medical products used for combatting the coronavirus.

Independently of the current situation, the Swiss Federal Council has been discussing measures to prevent supply shortages for pharmaceutical products recently. With an interpellation submitted at the end of 2019, a member of the Swiss Parliament asked the Federal Council to take measures to ensure security of supply of pharmaceuticals. At this time, over 600 basic pharmaceuticals were not available in Switzerland. The Federal Council published an answer to the interpellation on 19 February 2020 stating that the Swiss Federal Department of Home Affairs should issue a master plan for the period between 2020-2025 as well as a report with further measures in spring 2020. According to the Federal Council possible measures could include extended notification obligations for certain pharmaceuticals, incentives for the production of vaccines and pharmaceuticals in Switzerland and competences of the Federal Council to take into account the subject of security of supply in the pricing of pharmaceuticals. As far as can be seen, neither a master plan nor a report have been issued by the authorities up to now.