SMVO statement on the ViESV consultation draft
Consultation draft of the Federal Department of Home Affairs on the Ordinance on the unique identifiers and safety devices on the packaging of medicinal products for human use (ViESV)
Consultation deadline: August 27, 2025.
The most important facts in brief
The use of the SMVS will be mandatory for prescription medicines in Switzerland according to the will of the Swiss Federal Parliament. It offers patients security against counterfeiting and the supply chain a wide range of additional digital usage options to digitally accelerate the respective processes and document them in a traceable manner at the same time.
The SMVS has brought significant progress in digitalization to the Swiss healthcare system. In addition to counterfeit protection for medicines, it offers multiple additional benefits, savings and process optimization for the entire supply chain.
The SMVO agrees with the Ordinance on the unique identifiers and safety devices on the packaging of medicinal products for human use (ViESV), including the annexes, and advocates the swift entry into force of the ordinance together with Art. 17a TPA.
In terms of methodology and empirical approach, the updated Regulatory Impact Assessment misses the point of a prospective cost-benefit analysis both economically and legally (cf. sections 4 a-g below) and is therefore not valid.
1. patient safety and additional benefits thanks to digital database
with counterfeit protection for medicines
The SMVS allows immediate and reliable information to be obtained with a scan that can be connected to all 2D scanners via a free interface,
whether the sales date of a product has expired,
whether the product is recalled
or whether the product is counterfeit.
The SMVS offers a wide range of additional benefits, especially for those who dispense medicines, such as hospitals, self-dispensing doctors and pharmacists, thanks to the mandatory use decided by Parliament.
In particular, the following processes can be digitally mapped and the necessary data can be captured quickly, easily and without errors using the 2D scanners that are commonly used everywhere:
Error-free and fast data acquisition
Savings in human resources, which are becoming increasingly valuable due to the shortage of skilled workers
Compliance with and design of GDP processes
Warehousing and inventory management (e.g. according to the FEFO principle)
Sale or returns before the expiration date
Recalls can be implemented quickly and completely down to patient level, which is documented digitally and automatically in the company's own primary system
Digitization progress that ensures data security through electronic recording
Support for future requirements in connection with medication dispensing and traceability.
Etc.
2. SMVO welcomes the ordinance
The ViESV implements the mandatory application of unique identifiers and safety devices on the packaging of medicinal products for human use adopted by Parliament in a practicable manner for Switzerland and exempts certain manufacturers from the serialization obligation in the annexes for good reason. The SMVO welcomes the ordinance in its entirety.
This is because the SMVS was created in 2018 at the expense of the industry and is already being used by many marketing authorization holders that export abroad. Of the approximately 280 companies that distribute Rx medicinal products in Switzerland as marketing authorization holders, it is estimated that more than 95% operate in Switzerland and abroad[1]. Around 3,500 products (SKUs) are currently serialized, which corresponds to around one third of the products concerned.
3. SMVS advances digitization
The SMVS must focus on the major advances in digitization, significant financial savings and quality improvements. They are an important building block for advancing the Swiss healthcare system. The SMVO must therefore also be understood and used as an important pioneer within the larger framework of the nationwide efforts to digitize the healthcare system[2].
This is because a number of digitization projects in the healthcare sector have so far failed with major financial losses and serious reputational damage. The databases had to be deleted along with their content in the form of real data due to irreparable deficiencies (e.g. organ donor register Swisstransplant[3], vaccination database MeineImpfungen.ch[4]).
Switzerland has fallen far behind in the area of digitalization in the healthcare sector. The expected high financial benefits of around CHF 8.2 billion [5] must be tapped into through coordinated investments and joint projects. [5] must be tapped into through coordinated investments and joint projects. The DigiSanté[6] program was launched accordingly and is now pursuing this goal. The SMVS has been paid for and implemented by the industry. It should be understood and used as part of these digitization activities.
4. more direct imports of medicines and supply bottlenecks
exacerbate the risk of counterfeiting
The risk of counterfeit medicines illegally entering the legal supply chain is also increasing in Switzerland, partly due to more direct imports from abroad[7], as the supply bottlenecks in Switzerland have long since affected more than just essential medicines[8]. Swissmedic has extended the right of medical professionals to import and temporarily store medicines that are not authorized or available in Switzerland and are urgently needed, even if they are not only intended for individual patients.
This measure is intended in particular to ensure the supply of urgently needed pediatric medicines[9].
In addition to counterfeit protection, the ViESV offers multiple additional benefits for patient safety and the medication manufacturing and dispensing processes. The SMVS brings significant progress in digitization, which saves resources and increases efficiency.
5. "Updated" Regulatory Impact Assessment (RIA)
In 2017, the FOPH submitted an initial ordinance for consultation with an optional form of serialization for medicinal products. Work on this was later suspended due to the coronavirus pandemic. After Parliament decided to make serialization mandatory, the FOPH commissioned an update of the Regulatory Impact Assessment RIA) and opened the consultation process in May 2025 with the new ordinance (ViESV).
a) Incorrect methodology and biased empirical approach
The entire report design and thus the update of the RIA commissioned by the FOPH suffers from a number of serious flaws in the methodology and empirical approach. As a result, it is unusable.
b) Retrospective instead of prospective view
Under Methodology (1.1), it is initially correctly stated that it is an instrument that serves toimprove legislation with the help of a "prospective analysis". However, the report analyzes the costs not only prospectively, but also retrospectively, and the two are incorrectly added together.
The schematic impact model (D.1.1) is based exclusively on Art. 17a TPA and raises the question of whether this provision would be useful. However, this question no longer arises, as it was answered in the affirmative by Parliament in 2017 and thus decided. The correct basis for an updated calculation of regulatory costs should therefore be the year 2024 or 2025, when the regulation was created as an ordinance to implement Art. 17a TPA.
The update should have referred to the current consultation draft and shed light on the costs of its mandatory implementation for those supply chain members who have not yet voluntarily joined the SMVS .
The costs that the industry has invested since 2018 in the creation and operation of the SMVS in preparation for and in reliance on the imminent entry into force of Art. 17a TPA and the associated ordinance - around CHF 10 million - have been invested in an actively used, functioning database that is indispensable for all exporting Swiss manufacturers and for the Principality of Liechtenstein.
c) Biased, unweighted empirical approach
The number of interview partners in the supply chain group varies. Their relevance is not weighted, associations and individual companies are rated equally, and the size of pharmacies or medical practices is not taken into account. An evaluation based purely on the number of individual opinions expressed must therefore undoubtedly be misleading in economic terms.
The empirical approach is described in section 1.2 as "the RIA of 2017 forms a central basis". As explained above, this is incorrect because the question of this regulation no longer arises (see section 5.a above).
Reference is then made to the 23 interviews conducted in 2017 with various stakeholders, which were "brought up to date". The (anonymous) interviewees were selected completely at random and in varying numbers.
Specifically, the following interviews are listed:[10]
| Submitting offices (9) | |
|---|---|
| SD practices (size unknown) | 2 SD doctors |
| Pharmacies (size unknown) | 2 pharmacists |
| Hospital pharmacies | 3 Hospital pharmacists |
| PharmaSuisse, FMH | 2 Associations |
| Wholesalers (2) | |
|---|---|
| Wholesaler | 1 Company |
| Pharmalog | 1 Association |
| Manufacturer (7) | |
|---|---|
| Export-oriented manufacturers(SMVO is incorrectly referred to as a manufacturer) | 2 Company |
| Local manufacturers with products for the Swiss market | 1 Association |
| Contract manufacturer packaging | 1 Company |
| Manufacturer associations(vips, but not Interpharma(!) plus two associations not affected by the regulation [11]) | 3 Associations |
The RIA then relies on "majorities"[12] or there are even statements such as: "according to the interviewees" or "according to the opinion of the interviewees"[13], which is certainly the wrong approach for an economic analysis due to the different weights, number of interviewees per group and affected parties.
No distinction is made as to which of the interviewees are already connected to the SMVS. This is because SMVS users have the most experience with the one-off and recurring costs that the system incurs, but also with its benefits.
The voices of those who do not yet use the SMVS appear to be greatly outnumbered in terms of number and weight, based on the above presentation. In this respect, too, the report is not useful.
d) Non-transparent assumptions
The report is also based several times on "assumptions"[14]. Multiplications or extrapolations are made on the basis of these assumptions, resulting in correspondingly opaque figures. It is also not clear to us on which data or interviews and from whom these (basic) assumptions could originate and whether they perhaps even - which would be incorrect - originate from the outdated RIA from 2017.
Other assumptions are also incomprehensible. In the charts, for example, six locations and three systems are assumed for the wholesalers[15], in the next chart regarding hospital pharmacies there is talk of four employees, further assumptions regarding full-time equivalents and annual salaries are added and extrapolated[16].
e) Benefit assessment not quantified
Although a chapter is dedicated to the benefits in the RIA [17], there are no figures, evaluation or quantification. Instead, the benefits are downplayed - especially by those who do not yet use the system.
The diverse benefits of the SMVS digital database are increasing massively thanks to the mandatory use of serialization. The RIA lacks figures on this.
According to Art. 5 para. 2 of the Corporate Relief Act (UEG, SR 930.31), the estimated costs are "compared as far as possible with the expected benefits of regulation". The expected benefit would therefore not only have to be calculated, but also compared with the (prospective!) implementation costs.
The lack of a benefit assessment also means that the true costs of the RIA are moving further and further away from reality.
f) Technological forestry steps in digitization
The technological progress made by all members of the supply chain and the actual digitization progress made seven and a half years after the creation of Art. 17a TPA, which were made in reliance on the SMVS, bring additional financially relevant benefits. The technical adjustments could, can and should continue to be made in accordance with the requirements of mandatory serialization.
g) Additional costs due to alerts?
Some of the costs in the RIA are attributed to the "many alerts of error messages". It should be noted that there are currently no reliable figures for Switzerland because the system is not yet fully utilized. We therefore refer to the figures in other EU countries and assume alerts of between 0.05% and >0.01%.
The RIA relies on Germany as the worst example in the area of alerts and also on a healthcare system that is not comparable with that of Switzerland. Austria, for example, would be much closer to our system. In addition, the RIA relies on alert rates from 2020 and 2021 instead of the monthly statistics published by the EMVO with significantly lower rates.
Die folgende Abbildung stammt aus dem EMVO Monitoring-Report vom Mai 2025 und zeigt die aktuelle Alert-Quote pro Land. Ziel ist eine Quote=< 0.05%. Österreich weist mit seinem gut mit der Schweiz vergleichbaren Gesundheitssystem eine Alertrate von 0.005% aus. Aber auch Deutschland lieg mittlerweile mit 0.054% auf dem Niveau der Soll-Quote.
Source: EMVO
Looking at the alert rate alone misses the point. The mostly manual effort already required today for irregularities detected on pharmaceutical packages must be compared with the much lower costs that will be incurred for alerts after the full introduction of SMVS .
Today, a service provider who discovers irregularities in a pack must remove it from the sales process and store it in a safe place. They have to check the pack personally at their supplier's premises, call or send an email and notify the authorities if they suspect anything and reliably document all this work. Like the other benefits, this considerable personnel and manual effort is neither quantified nor reported in the RIA .
Scanning supports the inspection process digitally and on the system side. The processing of alerts is also automatically and traceably documented in the system.
In addition, the SMVS actively supports the improvement of the alert rate by working through and solving the system-related, avoidable errors at the source through releases.
Sources
[1] RIA P. 21
[2] See Mo. Ettlin 21.3957 "Digital transformation in the healthcare sector. Catching up at last!", one of the rare motions to be unanimously passed by Parliament. See also the DigiSanté program, https://www.bag.admin.ch/bag/de/home/strategie-und-politik/nationale-gesundheitsstrategien/digisante.html
[3] The Swisstransplant Foundation Board decided on 1.12.2022 to delete all data from the organ donor register. The productive database was deleted on 05.12.2022.
[4] The Meineimpfungen foundation was taken offline in May 2021 due to major security gaps and massive breaches of data protection regulations.
[5] Cf. study by McKinsey & Company in cooperation with ETH Zurich from September 2021, Digitalization in the healthcare sector: the CHF 8.2 billion opportunity for Switzerland
[6] https://www.bag.admin.ch/bag/de/home/strategie-und-politik/nationale-gesundheitsstrategien/digisante.html (Online access 24.05.2025)
[7] With the creation of Art. 17a nHMG in 2017, Parliament decided to establish digital counterfeit protection for medicines in Switzerland.
[8] https://www.bag.admin.ch/bag/de/home/medizin-und-forschung/heilmittel/sicherheit-in-der-medikamentenversorgung.html (online access, 22.05.2025)
[9] Communication from Swissmedic dated April 29, 2025, according to which the term "emergency" in Article 49 of the Medicinal Products Licensing Ordinance (MPLO) will be temporarily extended.
[10] RIA P. 14
[11] The Swiss Association for Complementary Medicinal Products is not affected by the mandatory serialization because these prescription-only medicinal products have a low risk profile according to the explanatory notes to Annex 1 (see explanatory notes of the FOPH on the ViESV of May 2025, p. 11f.). The Swiss Association for Self-Medication is not affected by the ordinance because it does not represent prescription-only medicinal products.
[12] P. 17, 21, 52 RIA
[13] P. 38 RIA
[14] S. 6, 20, 22, 24
[15] Cf. RIA D 3.3 p. 24
[16] Cf. RIA D 3.5, p. 29
[17] Chapter 3.3, Sections 3.3.1-3.3.5