Roche Holding AG

Lobbying Governance

AI Extracted Evidence Snippet Source

_This position paper was proposed by the Corporate Sustainability Committee and_ _adopted by the Corporate Executive Committee on May 14, 2018 and entered into_ _force the same day._ _It was revised in June 2021._

https://assets.roche.com/f/176343/x/b1beb82dab/07_position-paper-energy_june-2021-doc.pdf

**Our position**
We engage regularly and systematically with our internal and external stakeholders to understand their needs and build mutual trust. We ensure that we address legitimate interests of our stakeholders to make informed decisions on how we run our business.

For example:

* We partner with patients, caregivers and patient organisations at each stage of drug development and care delivery.
* We work closely with our suppliers and service providers to better create, enhance and deliver sustainable value.
* By continuously engaging with policy makers, we ensure Roche creates long-term impact not only for patients, but society as a whole.

https://www.roche.com/investors/reports/materiality

We believe it is our duty to contribute constructively and fairly to the public debate on a variety of healthcare issues. Our expertise and knowledge enables us to inform and advise regulators and other government authorities on high-priority issues such as: * research and development of pharmaceuticals * innovation in healthcare * access to healthcare, particularly in developing countries We are convinced that a proactive, transparent and responsible engagement between government officials and the private sector is fundamental to good public governance. Such interaction can make a significant contribution to a healthy democratic process, providing a necessary link between business, policymakers and civil society. We have establishedfor our relationships with government officials. We expect any contractor or agency working for or on behalf of Roche to fully abide by these guidelines when engaging with government officials. We work closely with business and industry associations to help ensure the legal, regulatory and political environment in which we operate represents a variety of viewpoints.

https://www.roche.com/about/sustainability/approach/stakeholder-engagement

The Board of Directors has established a system of controls which is continuously monitored by the Audit Committee, by the Corporate Governance and Sustainability Committee and by the Board of Directors and consists of the following elements: [...] The Roche Group has established a risk management process covering the entire company with a system in place to identify and manage all types of risks and opportunities potentially affecting its business (including economic, environmental and social impacts). The Board of Directors is the highest governance body involved. Roche's Risk Management Policy sets out the approach and accompanying responsibilities. Roche's Pharmaceuticals and Diagnostics Divisions and Group functions conduct a formal assessment process at least once a year and must develop management plans for their most material risks and opportunities. These risk management plans are monitored and deviations reviewed in regular performance dialogues. The consolidated Group Risk Report including target risk profile is discussed by the Corporate Executive Committee and approved together with the Group Business Plan by the Board of Directors. All material risks are reviewed by the Board on a yearly basis. The effectiveness of the risk management process is monitored by the Group Risk Advisory team and the overall process is regularly reviewed by external auditors, with findings presented to the Audit Committee and the full Board. For details on risk management and the Risk Management Policy, see 'Risk management' on our website.

https://assets.roche.com/imported/06_Ar23e.pdf

The Board of Directors has established a system of controls which is continuously monitored by the Audit Committee, by the Corporate Governance and Sustainability Committee and by the Board of Directors and consists of the following elements: [...] The consolidated Group Risk Report including target risk profile is discussed by the Corporate Executive Committee and approved together with the Group Business Plan by the Board of Directors. All material risks are reviewed by the Board on a yearly basis. The effectiveness of the risk management process is monitored by the Group Risk Advisory team and the overall process is regularly reviewed by external auditors, with findings presented to the Audit Committee and the full Board. For details on risk management and the Risk Management Policy, see 'Risk management' on our website.[9] Financial risk management is described in the Finance Report.[10] [...] Group Audit reports administratively to the General Counsel, has direct access and gives regular briefings to the Audit Committee, to the Corporate Governance and Sustainability Committee and to the Chairman of the Board of Directors about ongoing activities and audit reports. The Chief Audit & Risk Advisory Executive attends the Audit Committee and partly the Corporate Governance and Sustainability Committee meetings, as do the external auditors. Group Audit is an independent appraisal function which evaluates and reviews the Group's activities as a service to the Board of Directors and to management. The annual audit plan with yearly defined focus areas is validated by senior management and approved by the Audit Committee. The Roche Group is committed to maintaining a high standard of internal control throughout its worldwide operations. Management is responsible for assessing the business risks in all aspects of its operation and for implementing effective and efficient processes and controls whilst ensuring compliance with internal and external rules and regulations. By conducting operational audits, Group Audit determines management's response to the risks surrounding business processes and systems, and evaluates the appropriateness, completeness and efficiency of the processes and controls. Action plans to implement necessary changes and enhancements are developed together with the business/auditee and are tracked to completion.

https://assets.roche.com/f/174029/x/2fb3fece51/roche-global-annual-report-2023.pdf

# Our approach to public policy

Government bodies and public officials play an important role in society, for example by establishing and maintaining the necessary conditions and institutions for economic stability, social cohesion and environmental protection as well as for providing access to healthcare for their citizens. For all these reasons, Roche considers and respects public policy stakeholders as important partners.

We are convinced that proactively and responsibly engaging with public policy stakeholders is a fundamental aspect of good public governance. We seek to inform and work closely with government officials in order to highlight and address the issues that affect the healthcare industry and advance its regulatory framework.

As we focus on finding new medicines and diagnostics that help patients live longer, better lives and that evolve the practice of medicine, we believe that it is our responsibility to share relevant data and insights, as well as our perspective, to inform the public debate.

We strive to strengthens stakeholders' understanding of—and trust in—our business, explaining what we do, how we do it and our contribution to society. We are convinced that this responsible and constructive form of lobbying is in the interest of all parties involved and of society as a whole.

Roche is committed to participating in a constructive, transparent, sincere and responsible dialogue with government officials by providing relevant, coherent, conclusive and honest information.

All employees working with government officials are expected to act in a legal and transparent way, complying with all applicable laws and regulations as well as with the standards set out in our

Currently, our two key issues of engagement are the following:

**Access & Innovation**

* How to provide patient access to our medicines and diagnostics
* How to create a culture which fosters innovation, e.g. by granting intellectual property (IP) protection
* How to get a fair value for our innovative products, devices and services

**Personalised Healthcare**

* How to develop innovative approaches to personalised healthcare
* How to ensure access to big data

Roche remains independent of any political affiliation. Where appropriate, Roche discloses contributions to associations and political institutions publicly and signs up in transparency registers of public authorities. Further details related to Switzerland, the US and EU institutions are listed below.

We actively participate in public discussions through our engagement and contributions to trade and industry associations such as the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), Biotechnology Industry Organization (BIO), Pharmaceutical and Research Manufacturers of America (PhRMA), interpharma Switzerland, MedTech Europe and Advanced Medical Technology Association (AdvaMed). These groups represent the biopharmaceutical and diagnostics industry in the public debate and advocate public policies that support innovation and that will benefit patients, healthcare systems and society as a whole.

We believe it is important to engage with a broad range of external stakeholders to ensure diverse perspectives are considered. We partner with third party organisations to inform our policy positions and further our shared goal of advancing innovation and making a positive impact on society.

In Switzerland, we spent 9.1 mCHF in 2022, which includes payments to industry associations and various chambers of commerce, financial assistance for trade unions, and donations to political parties at the cantonal and federal levels. Donations to political parties accounted for 2.93% of total contributions and donations.

In the US, our lobbying expenditures on federal initiatives in 2022 was USD 9.3 million.

We engage with government officials, legislatures, and agencies on policies to advance the development of new medications and ensure patient access to those innovations. Our lobbying activities allow us to educate policymakers on our positions and their impact on the regulatory environment, patient access, intellectual property, personalised healthcare, and business climate issues. We are committed to the highest levels of integrity in our interactions with policymakers and strictly adhere to federal and state laws.

GenenPAC and RocheGGC PAC are nonprofit political action committees (PACs) that accept voluntary contributions from eligible Genentech and Roche employees for distribution to federal and state political candidates. GenenPAC and RocheGGC PAC allow employees to have a voice in encouraging the election of legislators dedicated to helping the biotechnology and diagnostics industries and the patients we serve.

Both PACs are governed by an independent Board of Directors comprised of Genentech and Roche employees. PAC contributions are reported to the federal government twice annually. In 2022, GenenPAC and RocheDX PAC contributed $503,350 to federal and state candidates in a bipartisan manner.

Genentech is a member of several trade and industry associations that represent the biopharmaceutical industry and business community in policy discussions. Together we help drive consensus on policy, business, and Diversity, Equity and Inclusion priorities, advocating for solutions that will benefit patients, our healthcare system and society as a whole.

(These contributions are reported monthly to the US Federal Election Commission (FEC):and)

In 2022, we contributed USD 2,8 million to associations in the US toward sponsorship, meetings, advocacy campaigns, and lobbying activities, however the amount spent on lobbying varies from organisation to organisation.

(Further information about our advocacy activities with the US institutions can be found in theandlobbying disclosure databases.)

We maintain a transparent dialogue with representatives of the relevant EU institutions, including the European Parliament and the European Commission. While one person is focusing on EU affairs in Brussels, Belgium, most activities are conducted by colleagues from our headquarters in Basel, Switzerland.

Since 2009, Roche has provided information about its advocacy activities, relating to the decision-making of EU institutions through the EU Transparency Register. Disclosed costs encompass a broad range of activities, including all activities targeted at directly or indirectly influencing the formulation or implementation of policy and the decision-making process of the EU institutions.

For 2022, Roche estimated its annual costs between EUR 1,500,000 and 1,749,999. This estimate follows the guidance provided by the European Federation of Pharmaceutical Industries and Associations (EFPIA). As Roche works closely with associations, a significant part of the disclosed costs accounts for the membership fees of the associations that represent Roche at EU level.

Further information about our advocacy activities with EU institutions can be found in the
about our vision of healthcare in the light of the new EU Pharma Strategy.

https://www.roche.com/about/sustainability/impact/public-policy

The Corporate Governance and Sustainability Committee of the Board of Directors is responsible and accountable for governing sustainability at the Board level. It supervises Roche's sustainability strategy across all environmental, social and governance matters including climate change, access to innovation and product sustainability. Climate-related risks are embedded in the way we manage risks across our organisation. The Corporate Governance and Sustainability Committee and the responsible Corporate Executive Committee members regularly discuss identified risks, potential opportunities and mitigation measures. [...] The Corporate Executive Committee has delegated the responsibility for establishing, managing and coordinating the implementation of the sustainability strategy to the Corporate Sustainability Steering Committee. This committee submits regular reports on its activities to the Corporate Executive Committee and to the Corporate Governance and Sustainability Committee of the Board of Directors. The Corporate Sustainability Steering Committee is chaired by a person nominated by the CEO. Its members are appointed by the Corporate Executive Committee and are subject to review and revision on a regular basis.

https://roche.com/ar24e.pdf

#### Consultation of the Goals

The goals were reviewed in an extensive Roche-internal and –external consultation process. We received a broad consensus on the goals.

#### Implementation

All sites are required to define local goals in support of the global goals, to set up an action plan which ensures that these local goals will be achieved, and implement the plan accordingly. Not all sites can make similar contributions to all the global goals, but every site must make a fair effort to contribute where they can best, using the available resources most efficiently.

The General Manager / Site Manager is responsible for the SHE goals. She/he is supported by the SHE Officer and Site Security Officer in defining the goals, developing the action plans and implementing them.

We will further communicate on these goals, describing more details of the goals and the KPIs as needed.

https://assets.roche.com/f/126832/x/70206811f5/20200331-she-goals-2020-2025-communication.pdf