Compliance
We attach key importance to performing our business activities ethically and in compliance with the law. All our activities conform to the applicable laws.
Our approach to this matter
The Galenica Group’s Legal Department supports the Service and Business Units in interpreting and applying all legal requirements correctly. It also ensures that new statutory requirements are duly observed across the Group. The challenges currently facing Galenica concern the implementation of the new provisions under the revised Therapeutic Products Act and the forthcoming amendment of the Swiss Data Protection Act.
Galenica Group’s Code of Conduct
The Galenica Group’s Code of Conduct defines the ethical rules and standards that must be followed by all employees on top of the legal requirements. Managers are responsible for addressing and responding to specific conflict situations in day-to-day business.
The Retail Business sector has adopted a separate Code of Conduct of its own. As a binding internal operating procedure, it aims to ensure that pharmacists have full pharmaceutical independence at all times and thus always give priority to the health and wishes of the patient. The Code also defines the standards by which employees must act towards third parties as well as the advertising activities that are permitted.
Supplier Code of Conduct
Galenica seeks to ensure that not only the Group and its companies but also its business partners comply with international and national laws and standards, industry-specific standards and good practices. The Supplier Code of Conduct applies to suppliers, service providers and advisors of the Galenica Group. It covers aspects relating to ethical behaviour and labour law as well as health, safety, quality and the environment. Employees in the Purchasing departments undergo training that familiarises them with the content of the Code. In addition, the Legal Department is always involved in important Group-wide contracts. It also regularly reviews the Galenica Group’s contract templates to identify any compliance risks.
Comprehensive quality management
All Galenica Group companies have comprehensive quality management systems (QMS). Alloga, Medifilm, Mediservice, UFD and all HCI Solutions locations are certified according to ISO 9001. Verfora, Bichsel and HCI Solutions are certified according to ISO 13485 (design and production of medical products). In addition, the Bichsel Group’s QMS is structured in accordance with the European Medicines Agency’s ICH Q10 standard. The production of sterile, aseptically filled and biological medications places the highest possible demands on the implementation and maintenance of a QMS. Reflecting the critical relevance of its products, Bichsel undergoes an intensive broad-based audit every two years to ensure conformity to ISO 13485 and the statutory requirements set out in GMP and GDP.
The process management systems at Galexis and the former Retail Business sector companies also meet the ISO 9001 requirements but are currently not certified. Alloga, Galexis, G-Pharma, Mediservice and Verfora are periodically inspected by the Regional Medicines Inspectorates as part of Good Distribution Practice (GDP) audits.
In the Retail Business sector, the Amavita, Sun Store and Coop Vitality pharmacies have established a QMS covering all essential processes in retail pharmacies as well as environmental issues. Compliance with internal and external standards is monitored with regular quality audits, inspections by cantonal pharmacists and mystery shopper programmes. The QMS of the Mediservice specialty pharmacy fulfils stringent requirements due to its wide range of activities.
Facts and figures
Group-wide anti-corruption policy developed
In the year under review, the Legal Department drafted an anti-corruption policy for all Galenica Group companies. This policy defines the principles and rules for the prevention of corruption and governs the implementation of these by employees and business partners of the Galenica Group. All direct and indirect forms of corruption or bribery towards officials or private individuals are prohibited. The policy supplements the Group’s Code of Conduct as well as the Supplier Code of Conduct and is binding on all employees. The anti-corruption policy came into effect at the beginning of 2021.
Full compliance with the law achieved again in 2020
All Galenica Group companies once again operated in compliance with the law in 2020: no fines were imposed for any failure to comply with statutory requirements.
COMCO fine referred to the Federal Administrative Court
In a ruling dated 20 March 2017, the Swiss Competition Commission (COMCO) imposed a fine of CHF 4.5 million on HCI Solutions. This relates to an investigation from 2012 in which COMCO’s main allegations could not be substantiated. Of the six allegations investigated, two subordinate issues remained open. Galenica and HCI Solutions regard the ruling issued by COMCO in relation to these remaining issues as incorrect in fact and in law. Galenica and HCI Solutions therefore referred the decision to the Federal Administrative Court on 4 May 2017, where it is still pending.
In September 2019, COMCO launched inquiries into Markant Handels- und Industriewaren-Vermittlungs Ldt. and its customers including Galexis Ltd. The company does not expect the proceedings to result in the imposition of any sanctions on Galexis Ltd., although the possibility of a fine cannot be entirely ruled out.
Outlook for 2021
Galenica is introducing an external whistleblower system in 2021. This will give all employees and business partners a channel for reporting any suspected compliance breaches anonymously.