Regulatory Reforms: Switzerland
Key legal info on regulatory reforms in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for USD 99.
1. Are there proposals for reform or significant change to the healthcare system?
The revised Therapeutic Products Act (TPH) entered into force on 1 January 2019. Current therapeutic products legislation projects are listed on the website of the Federal Office of Public Health (hereinafter: FOPH) (cf. https://www.bag.admin.ch/bag/en/home/medizin-und-forschung/heilmittel/aktuelle-rechtsetzungsprojekte.html, last visited on 27 January 2020). Current legislation projects in the area of health insurance are also listed on the website of the FOPH (cf. https://www.bag.admin.ch/bag/de/home/versicherungen/krankenversicherung/krankenversicherung-revisionsprojekte.html, last visited on 27 January 2020). The following overview is intended to provide basic information concerning five major legislation projects.
1) Ordinary revision of the TPA
After several years of discussion, the revised TPA entered into force on 1 January 2019 (some dispositions entered into force earlier).
One of the main aims was to facilitate market access for certain medical categories by creating new and simpler access opportunities (e.g. new authorization procedures for medicinal products approved in an EU or EFTA country) and to simplify self-medication by modifying the allocation of medicinal products to different supply categories (cf. chapter 1, questions 3 and 14).
A second aim was to improve drug safety in general: The market supervision was modernised and tightened up (e.g. introduction of the pharmacovigilance plan, application of Good Vigilance Practice, increased scope and more detailed definition of reporting obligations). The safety of medicinal products used in paediatrics was also improved: A new register for off-label dosage recommendations for the medicinal products used in paediatrics was created (cf. https://swisspeddose.ch/, last visited on 27 January 2020) and new obligations and incentives for the pharmaceutical industry to promote the development of paediatric medicinal products were established. Minimum requirements for the prescription of medicinal products were defined as well.
The last of the three main aims was to increase transparency. For instance, the assessment reports for human medicinal products with new active ingredients on which the authorization decisions are based (so-called SwissPAR) and the summary report of the results of clinical trials are now published by Swissmedic.
(This overview is based on the information provided by the FOPH, cf. https://www.bag.admin.ch/bag/en/home/medizin-und-forschung/heilmittel/aktuelle-rechtsetzungsprojekte/ordentliche-revision-hmg.html, last visited on 27 January 2020).
2) Total revision of MPLO and Falsified Medicines Directive:
The totally revised Ordinance on Licensing in the Medicinal Products Sector (MPLO) (Verordnung über die Bewilligungen im Arzneimittelbereich vom 14. November 2018 [Arzneimittel-Bewilligungsverordnung; AMBV; SR 812.212.1]) entered into force on 1 January 2019. One of the main aims of this total revision is to improve the safety of medicinal products.
The modifications will improve, among others, medicine control and traceability in the distribution chain. Intermediaries now face greater responsibility in the medicines market. Another new aspect concerns experimental medicines: They can now be administrated for a limited period in certain cases. This first part entered into force on 1 January 2019.
A second step is the implementation of new safety features: An unique identifier will make it possible to verify that medicinal products are authentic. An anti-tampering device is intended to detect whether packages have been opened. The new art. 17a TPA concerning the voluntary placing of safety features to medicinal product packaging as well as the detailed provisions that are regulated in a separate ordinance are not yet in force. Those new dispositions will probably enter into force in 2020.
(This overview is based on the information provided by the FOPH, cf. https://www.bag.admin.ch/bag/en/home/medizin-und-forschung/heilmittel/aktuelle-rechtsetzungsprojekte/ratifizierung-medicrime-konvention.html, last visited on 27 January 2020).
3) Therapeutic products: integrity, transparency and discounts:
The new Ordinance on Integrity and Transparency in the Context of Therapeutic Products (OITTP) (Verordnung über die Integrität und Transparenz im Heilmittelbereich vom 10. April 2019 [VITH; SR 812.214.31]) entered into force on 1 January 2020. It was adopted on the basis of the new articles 55 and 56 TPA. At the same time, art. 33 TPA (Promises and acceptance of material benefits) was abolished.
Article 55 TPA (Integrity) regulates, in general, that the choice of treatment must not be influenced by financial incentives. Doctors have to choose a treatment exclusively under scientific and objective criteria. This provision applies to the prescription, supply and use of prescription medicinal products.
However, the Federal Council (Bundesrat) may extend the scope to other categories of therapeutic products. Gifts with a maximum value of 300 Swiss francs per year that are relevant to the medical or pharmaceutical practice are allowed. Contributions for research, education and training are allowed under certain circumstances as well.
Second, the new regulation is stricter concerning discounts and bonuses. Article 56 TPA (Duty of transparency) stipulates that all price discounts and refunds granted on therapeutic products (which means medicinal products and medical devices) must be reported and disclosed to the FOPH upon request. The provision shall apply to both, purchase and sale of therapeutic products. Therapeutic products with a low risk potential are excluded from the scope of art. 56 (e.g. Class I medical devices).
The responsible authority for the enforcement is the FOPH. It can order administrative measures and conduct administrative penalty proceedings.
(This overview is based on the information provided by the FOPH, cf. https://www.bag.admin.ch/bag/en/home/medizin-und-forschung/heilmittel/aktuelle-rechtsetzungsprojekte/integr-transp-obligation.html, last visited on 27 January 2020).
4) Total revision of medical devices legislation:
One of the most controversial legislative projects in the field of therapeutic products is the total revision of the Medical Devices Ordinance (MedDO) (Medizinproduktever-ordnung vom 17. Oktober 2001 [MepV; SR 812.213]). The main purpose of this total revision is to harmonise Swiss medical device law with the EU’s new medical device regulation (EU-MDR).
The medical device industry plays an important economic role in Switzerland and generates more than 70 percent of their sales through exports, half of which go to the EU. This corresponds to approximately 4 percent of all Swiss exports (export volume 10.6 billion Swiss francs) and a share of 2.2 percent of the Swiss gross domestic product (cf. Bundesamt für Gesundheit BAG, Totalrevision der Medizinprodukteverordnung und Verordnung über klinische Versuche mit Medizinprodukten (neue Medizinprodukte-Regulierung), Erläuternder Bericht, Mai 2019, page 7, https://www.bag.admin.ch/bag/de/home/medizin-und-forschung/heilmittel/aktuelle-rechtsetzungsprojekte/revision-med-prod-verord-mepv.html, last visited on 27 January 2020). Considering the great economic importance, the question arises as to why the revision was controversially discussed in Switzerland. First of all, the new MedDO, same as the EU-MDR, will bring fundamental change to all actors on the market. There are now numerous obligations not only for manufacturers, but also for traders. However, the most controversial point with regard to Switzerland was the unique adoption of EU law by the Swiss parliament. On the one hand, the MedDO refers directly to the EU-MDR in numerous dispositions. On the other hand, both, implementing and delegated acts adopted by the European Commission automatically enter into force for Switzerland too.
The situation is even more complex: In addition to the harmonization of medical device legislation updates to the Mutual Recognition Agreement (MRA) need to be negotiated by the Switzerland‑EU Joint Committee in order to introduce mutual obligations for Switzerland and the EU at international treaty level (cf. https://www.bag.admin.ch/bag/en/home/medizin-und-forschung/heilmittel/aktuelle-rechtsetzungsprojekte/revision-med-prod-verord-mepv.html, last visited on 27 January 2020).
Should Switzerland not align its legislation with that of the EU (or should the MRA not be updated by the Switzerland-EU Joint Committee), some Swiss medical device manufacturers could lose their market access to the EU. This risk exists in particular for manufacturers with no subsidiaries in the EU who have had their products assessed by a Swiss conformity assessment body. However, if a Swiss manufacturer with a subsidiary in the EU has his products certified by a conformity assessment body in the EU, he still has access to the EU market under EU law (regardless of Swiss law).
In May 2019, the FOPH published a first draft of the new MedDO. The consultation procedure ended in September 2019. The final version of the MedDO has not yet been published. However, it is unlikely that the draft will be substantially amended, as equivalence with the MDR is one of the primary objectives of the revision (cf. for detailed information: https://www.bag.admin.ch/bag/en/home/medizin-und-forschung/heilmittel/aktuelle-rechtsetzungsprojekte/revision-med-prod-verord-mepv.html, last visited on 27 January 2020). The new MedDO should enter into force by 26 May 2020 at the latest (cf. Bundesamt für Gesundheit BAG, Totalrevision der Medizinpro-dukteverordnung und Verordnung über klinische Versuche mit Medizinprodukten (neue Medizinprodukte-Regulierung), Erläuternder Bericht, Mai 2019, page 47, https://www.bag.admin.ch/bag/de/home/medizin-und-forschung/heilmittel/aktuelle-rechtsetzungsprojekte/revision-med-prod-verord-mepv.html, last visited on 27 January 2020).
5) Revision of the HIA: regulatory measures to contain costs:
Swiss health insurance law is often partially revised several times a year. However, these revisions usually do not result in major system changes, but small changes that are just as important, especially when it comes to so-called “cost-saving measures”. Switzerland has one of the most expensive healthcare systems.
As a consequence, cost-saving measures have been the subject of constant political discussion for years. Almost all sides (politicians, hospitals, doctors, insurers, patients etc.) agree that health care costs are too high. There is consensus that savings must be made, but there is no consensus on how these savings can be achieved.
In August 2019, the Federal Council adopted the first of several packages of so-called “cost containment measures” (Massnahmen zur Kostendämpfung – Paket 1). This package must now be discussed in Parliament.
The content of this first proposal is highly technical, complicated and controversial. Only one example is given below: The Federal Council proposes the introduction of a so-called “reference price system for medicinal products” (Referenzpreissystem für Arzneimittel). To begin with, generics are more than twice as expensive in Switzerland as in the nine European reference countries considered by the FOPH for pricing purposes. The FOPH shall determine the maximum amount insurers have to pay for patent-expired medicinal products and generic products with the same active ingredient. If a more expensive drug is sold, the insured must pay the difference to the reference price. With the introduction of a reference price system, savings of 310-480 million Swiss francs could be realized (cf. Bundesamt für Gesundheit BAG, Faktenblatt Referenzpreis-system bei Arzneimitteln vom 21. August 2019, https://www.bag.admin.ch/bag/de/home/versicherungen/krankenversicherung/krankenversicherung-revisionsprojekte/kvg-revision-massnahmen-zur-kostendaempfung-Paket-1.html, last visited on 27 January 2020). It is currently impossible to predict when, how and whether these provisions will enter into force.
(This overview is based on the information provided by the FOPH, cf. https://www.bag.admin.ch/bag/de/home/versicherungen/krankenversicherung/krankenversicherung-revisionsprojekte/kvg-revision-massnahmen-zur-kostendaempfung-Paket-1.html, last visited on 27 January 2020).
2. When are they likely to come into force?
This aspect is already outlined in question 1.