PLA BYLAWS
Articles of Incorporation
PHARMALEDGER ASSOCIATION
English Translation
3 March 2023
1.1. Under the name "PharmaLedger Association" there exists an Association within the meaning of Art. 60 ff. of the Swiss Civil Code.
1.2. The Association is politically and religiously neutral.
1.3. The Association exists for an indefinite period.
1.4. The registered office of the Association is in Basel, Switzerland.
2.1.1. The purpose of the Association is to create and promote a digital trust ecosystem in the healthcare sector by providing a standardized and
trustworthy open platform. The Association promotes cooperation in the healthcare and life science sectors and promotes innovations and their
implementation for the mutual benefit of patients and other stakeholders.
2.1.2. A digital trust ecosystem is an interdependent set of actors (people, businesses, things) that share standardized digital solutions to create
shared benefits across healthcare.
2.1.3. The Association is non-profit and does not pursue any gainful, self-help or commercial purposes.
2.1.4. The Association can take generally necessary and suitable measures to achieve the aforementioned purpose, such as:
- coordinating management and cooperation between the stakeholders involved in connection with projects and products managed by
the Association.
- Quality and data protection management, including checking compliance of the products managed by the Association with
regulatory and legal requirements.
- Assistance in the testing and application of the products managed by the Association.
- Project incubation, experimentation and prototyping, including technology research and development.
- Training and promoting projects and products managed by the Association.
- Planning and implementation of initiatives and taking part in initiatives of other organizations or providing financial or other support
to other organizations or individuals, insofar as all these activities serve the purpose of the Association.
2.1.5. In order to pursue its purpose, the Association may also accept donations from third parties and act as a trustee.
2.1.6. The Association does not pursue any commercial goals and does not aim to make a profit.
2.2.1. In pursuing its purpose, the following "Core Values" shall also guide the Association's decisions and actions:
2.2.1.1. Patient focus. Healthcare exists for patients, and patient involvement and empowerment is central to the Association's
mission.
2.2.1.2. Ecosystem led.. The Association is led by members of the healthcare ecosystem to ensure that activities undertaken to
achieve the Association's purpose serve the collective needs of all healthcare stakeholders.
2.2.1.3. Inclusion. Building a trusted digital healthcare ecosystem requires commitment to ensure adoption, effectiveness and
sustainability. The Association aims to create a freely accessible platform that enables the widest possible application by the largest
possible community.
2.2.1.4. Neutrality. No party should have excessive control or influence over the Association. Decentralized leadership approaches
aim to ensure that the digital trust ecosystem benefits everyone and not just several participants.
2.2.1.5. Vendor and technology independence. The Association endeavors to avoid strong dependencies on specific providers or
technologies. The Association must be able to adapt quickly to a dynamically changing situation without making long- term
commitments that hamper innovation and competition.
2.2.1.6. No profit orientation. The Association acts as a collective resource for the common good and all funds available are
reinvested in furthering its purpose.
2.2.1.7. Easier is better. Healthcare is a very large and complex industry. The Association strives to reduce or eliminate
complexity in healthcare through its efforts.
2.2.1.8. Agility for change. The aim of the Association is to bring about change in the healthcare ecosystem through innovation. It
must be able to anticipate, react to and implement changes at all levels.
2.2.1.9. Open source model. The Association follows a decentralized software development model that promotes open
collaboration, transparency, trust, quality, diversity of thought and acceptance.
2.2.1.10. Transparency. The Association strives for transparency in all its activities. Decision-making processes should be clearly
defined and decisions should be communicated in a timely manner to build trust and ensure predictability for the Association's
stakeholders.
3.1.1. the General Assembly,
3.1.2. the Board,
3.1.3. the auditors (if appointed).
3.2.1. Articles, agenda items, participation
3.2.1.1. The General Assembly is the supreme body of the Association.
3.2.1.2. The Chair of the Board of Directors chairs the General Assembly.
3.2.1.3. The regular General Assembly takes place annually in the first half of the year.
3.2.1.4. The Board invites members to the General Assembly at least 20 days in advance, stating the agenda.
Invitations are sent electronically or via an online publication.
3.2.1.5. Agenda items must be addressed to the Board of Directors no later than 10 days before the General Assembly is
scheduled to take place. The Board is obliged to include the motions in the agenda.
3.2.1.6. If possible, the annual General Assembly shall take place physically.
3.2.2.Ad hoc General Assembly
3.2.2.1. An ad hoc General Assembly shall take place in the following cases:
3.2.2.2. By resolution of the Board of Directors or the General Assembly;
3.2.2.3. at the request of at least one fifth of the members;
3.2.2.4. at the request of the auditors, if they have been appointed.
3.2.3. Agenda
3.2.3.1. The General Assembly has the following agenda:
3.2.3.1.1. Approval of the minutes of the last General Assembly;
3.2.3.1.2. Amendments to the articles of incorporation;
3.2.3.1.3. Approval of the annual accounts and the annual report of the Board of Directors;
3.2.3.1.4. Confirmation of membership fees;
3.2.3.1.5. Approval of the annual budget;
3.2.3.1.7. Election (with the exception of the chair of the Executive Board, who should be a member of the Executive Board
due to his office) and dismissal of the members of the board, as well as appointment and dismissal of the auditors;
3.2.3.1.8. Resolution on the discharge of the board and the auditors;
3.2.3.1.9. Dealing with requests from the Board and members;
3.2.3.1.10. Dissolution of the Association; 3.2.3.1.10. Significant changes in dealing with intellectual property rights.
3.2.4. Universal Assembly
3.2.4.1. If no objection is raised, all members of the Association can hold a General Assembly without complying with the formal
requirements for convening.
3.2.4.2. At this meeting, all matters falling within the scope of business of the General Assembly are validly negotiated and decisions
can be made as long as all members are present.
3.2.5. Chair, Minutes
3.2.5.1. The chair of the General Assembly is the Chair of the Board and, if he/she is unable to attend, another member of the
Board.
3.2.5.2. Minutes are kept of the resolutions and elections made by the General Assembly. The minutes are to be signed by the
chair and the recorder.
3.2.6. Resolutions and quorum of the General Assembly
3.2.6.1. Each member has one vote.
3.2.6.1. The General Assembly has a quorum if two thirds of the members are present.
3.2.6.1. Subject to statutory law or these Articles, resolutions are passed and elections are made by an absolute majority of the
votes represented at the General Assembly. The chair has the casting vote.
3.3.1.1. The Board of Directors is made up as follows:
3.3.1.1.1. An unlimited number of Board members to be appointed by patron members, with each patron member having the right to nominate one (1) Board member.
3.3.1.1.2. Up to five (5) Board members drawn from the standard members.
3.3.1.1.2.1. The number of Board members appointed by standard members should not exceed the number appointed by patron members.
3.3.1.1.2.2. If the above provision should apply, the number of Board members appointed by standard members shall be reduced to the same number as the Board members appointed by patron members.
3.3.1.1.2.3. If the patron members do not appoint a Board member, the number of Board members appointed by the standard members shall be limited to two (2) until at least three (3) Board members are appointed by patron members.
3.3.1.1.2.4. If the patron members appoint a Board member during the current term of office in accordance with Article 3.3.2.2 of these Articles, the adjusted number of Board members appointed by the standard members should be taken into account at the next regularly scheduled General Assembly.
3.3.1.1.3. Up to two (2) Board members appointed by the public partners.
3.3.1.1.4. Up to two (2) Board members appointed by patient organization members.
3.3.1.1.5. In addition to the Board members appointed by the members, the chair of the Executive Board should be a member of the Board ex officio.
3.3.1.2. The chair of the Board of Directors (the "chair") is elected annually by a majority of the then-active members of the Board.
3.3.1.3. A deputy chair ("deputy chair") is elected annually by a majority of the then-active Board members who were not appointed by the patron members.
3.3.1.4. In other respects, the Board is self-constituting.
3.3.1.5. In addition, the Board of directors can issue and publish one or more regulations on the details of the organization and management (organizational regulations). Within the framework of the purpose of the Association, changes to the organizational regulation(s) are permitted at any time.
3.3.2. Term of office of Board members
3.3.2.1. Each Board member elected by a patron member is appointed for a term of three years, which concludes at the end of the third regular General Assembly that takes place after his appointment or with the end of the membership of the patron member who elected the Board member, if this occurs earlier.
3.3.2.2. Appointment of Board members by patron members during the term of office
3.3.2.2.1. The Board members elected by the patron members are appointed within 90 days of joining the Association for a term that ends with the next regular General Assembly. At the Assembly, these Board members are appointed for a three-year term in accordance with Article 3.3.2.1.
3.3.2.3. The Board members, who include the standard members, the public members and the patient organization members, are elected for a three-year term concluding at the end of the third annual General Assembly following their appointment.
3.3.2.4. The members of the Board of Directors are eligible for re-election and the number of terms of office they can have is unlimited.
3.3.2.5. In the event of a vacancy, the Board can appoint a temporary representative until the next ad hoc or regular General Assembly.
3.3.3. Dismissal of Board members
3.3.3.1. The Association can relieve Board members of their duties through a resolution of the General Assembly.
3.3.4. Board meetings
3.3.4.1. Quorum
3.3.4.1.1. At all ad hoc and regular meetings of the Board of Directors, the Board has a quorum if a majority of the officers then incumbent are present and the acts of the majority of officers present at a quorum shall constitute valid acts of the Board of Directors except as provided by these Articles or nothing else is provided for by law.
3.3.4.1.2. If quorum is not reached at a meeting of the Board of Directors, the members of the Board of Directors present may, from time to time, adjourn the meeting to another place, time or date. If the meeting is adjourned for more than twenty-four (24) hours, members who were not present at the meeting at the time of the adjournment shall be notified of it.
3.3.4.2. Regular meetings
3.3.4.2.1. The Board of Directors shall hold at least one meeting each year at a time and place it determines to appoint senior executives and discuss other matters. Other regular meetings of the Board of Directors may be held at such a time and place as the Board of Directors may determine by resolution from time to time.
3.3.4.3. Ad hoc meetings
3.3.4.3.1. Ad hoc meetings of the Board of Directors may be convened at any time and for any purpose by the chair or two members of the Board of Directors.
3.3.5. Agenda
3.3.5.1. In principle, the Board has all powers and duties that are not expressly assigned to the General Assembly or determined through a decision of all members by vote.
3.3.5.2. The duties of the Board include, in particular:
3.3.5.2.1. Planning and holding ad hoc and regular general meetings;
3.3.5.2.2. Proposing amendments to the Articles of incorporation;
3.3.5.2.3. Approval of the organizational regulations;
3.3.5.2.4. Preparation of the annual report
3.3.5.2.5. Signing contracts with service providers.
3.3.5.3. The Board strives to ensure transparency and diversity in the Association's bodies. The Board reports to the General Assembly on these matters every year as part of the annual report.
3.3.6. Representation and authority to sign 3.3.6.1. The Board and the chair represent the Association in public.
3.3.6.2. The Board determines who is authorized to sign and how signing will take place.
3.3.7. Remuneration
3.3.7.1. The Association shall not pay the Directors any remuneration for the services they render to it in this capacity. Directors shall be reimbursed for reasonable out-of-pocket expenses (including travel expenses) incurred solely in connection with their work for the Board.
3.3.8. Observer
3.3.8.1. The Board of Directors may appoint observers from time to time.
3.3.8.2. The observers should have special merit and contribute to the good reputation of the Association, both as individuals and as members of a group.
3.3.8.3. Observers shall be entitled to attend meetings of the Board, participate in the discussions and deliberations of the Board and (under such conditions as the Board may determine) have access to the materials made available to Board members for use in the discussions, deliberations and meetings of the Board. They shall have no other rights and privileges given to Board members.
3.3.9. Conflicts of interest of Board directors and executive officers
3.3.9.1. At least once a year, the Board of Directors requires each of its members and each member of the Executive Board to submit a declaration listing all business and other connections that are in any way related to the activities of the Association.
3.3.9.2. The Board establishes policies and procedures that specifically address conflicts of interest of directors and officers.
3.3.9.3. No director may vote on any matter in which he has a material and immediate financial interest that would be affected by the outcome of the vote.
The members of the Executive Board of the Association (each, a "member") include an Executive Director and, at the discretion of the Board, such other members as it deems appropriate. Any member of the Executive Board, with the exception of the Chief Executive Officer, may hold more than one office, but no member of the Board of Directors may simultaneously serve as a member of the Executive Board of the Association.
4.2.1. The Executive Director is responsible for all activities and business of the Association. All other officers and employees shall report to the Executive Director or his Deputy unless otherwise provided in these Articles of Incorporation. The Executive Director is an ex officio member of the Board and has the same rights and privileges as any other Board member. The Chief Executive Officer has the power to call ad hoc meetings of the Board in accordance with these Articles of Incorporation and shall carry out any other duties provided for in these Articles of Incorporation and which may be assigned by the Board from time to time.
5.1.1. Patron member
5.1.1.1. Patron members are members of the Association with full rights as such.
5.1.1.2. The number of patron members is unlimited.
5.1.2. Standard member
5.1.2.1. Standard members are members of the Association with full rights as such.
5.1.2.2. The number of standard members is unlimited.
5.1.3. Public members.
5.1.3.1. Public members are associate members of the Association.
5.1.3.2. They must be registered as non-profit or government organizations to be eligible for membership.
5.1.3.3. The number of public members is unlimited.
5.1.4. Patient Organization Members
5.1.4.1. The patient organization members are associated members of the Association.
5.1.4.2. Patient organizations must be organizations with the mission or purpose to represent or advocate for patients in healthcare to be eligible for membership.
5.1.4.3. The number of patient organization members is unlimited.
5.2.1. The Executive Director may take all necessary measures to admit new members to the Association.
5.2.2. Judicial persons
5.2.2.1. All members of the Association must be judicial persons. The Association does not accept natural persons as members.
5.2.3. Nexus to the healthcare ecosystem
5.2.3.1. All prospective members must demonstrate their connection to the healthcare ecosystem (relationship or connection) as part of their application. This nexus is assessed as part of the admissions process.
5.2.4. In the event of any dispute regarding membership, the decision of the Board is final. Only Section 5.5.3 remains unaffected.
5.2.5. Any refusal to become a member must be communicated to the applicant in writing and justified within six (6) months of the date of the formal application.
5.3.1. The General Assembly confirms the annual membership fee for each category of members based on a proposal by the Board. It is collected before the start of the next year of membership. If a full member joins the Association during the fiscal year, the membership fee is charged pro rata.
5.3.2. Membership fees will be charged for the first time for membership year 2023.
5.3.3. The current membership fees are recorded in the membership agreement.
5.4.1. Membership ends:
5.4.1.1. Through withdrawal, expulsion or dissolution of the legal entity.
5.4.1.2. Through the liquidation of the Association.
5.4.1.3. The Association is not obligated to refund any fees that have already been paid in any of the above cases.
5.5.1. Members can be expelled from the Association in the following cases:
5.5.1.1. if the member breaches any of his obligations to the Association arising under these Bylaws, the Membership Agreement or any End User Agreement, or the Association determines in its sole discretion that a member has committed a material breach of the Bylaws, the Membership Agreement or any End User Agreement.
5.5.1.2. if the member fails to make any payment or advance required under any Grant Agreement or threatens to suspend payment or default;
5.5.1.3. the Board has determined that the member no longer meets required membership standards or technical requirements, or has reason to believe that the member has acted fraudulently or dishonestly, etc.
5.5.1.4. in the case of circumstances which constitute an important reason for the suspension of membership in order to avoid risk to the proper operation, security, integrity or reputation of the Association; or
5.5.1.5. the member is affected by insolvency.
5.5.2. Expulsion decisions are made by the Board and can be appealed before the General Assembly within 20 days.
5.5.3. The decision to expel a member is made by the Board and can be appealed within 20 days before the General Assembly.
5.5.4. If a member fails to pay the membership fee despite a reminder, they can be expelled by the Board.
5.5.5. Expelled members owe the full membership fee for the current year.
5.6.1. Members wishing to withdraw from the Association must give notice of at least six (6) months before the end of a calendar year or, if a contractual year is the relevant point of reference, six (6) months before the end of the contractual year. The application for withdrawal / resignation must be submitted to the Board.
5.6.2. The resigning members owe the full membership fee for the current year.
6.1. The Association supports constant innovation through research, idea generation, evaluation, development, prototyping, incubation and dissemination.
6.2. The Association will use at least 5% of the gross income from membership fees to finance innovation activities. In addition, donations or other income can be used for innovation activities that serve the purpose of the Association.
6.3. Within the scope of the Association's purpose, it can set up and finance an innovation laboratory in addition to other activities or plan, implement and/or participate in innovation initiatives with other organizations.
7.1.1. The income of the Association comes from:
- membership fees
- Interest from the Association's assets
- donations, endowments, legacies and grants of all kinds,
- Contributions and subsidies from public institutions,
- income from service contracts,
- Proceeds from events and fundraisers,
- Revenue from trade and advertising.
7.2.1. Only the assets of the Association can serve as liabilities. Personal liability of the members for liabilities of the Association is excluded.
7.3.1. The Association's fiscal year is set by the Board from time to time.
7.4.1. Beginning at the end of 2024 and then at the end of each subsequent year, the Association's accounts are audited by a state supervised auditing company within the meaning of Art. 727b Para. 1 OR according to a suitable accounting standard to be determined by the Board.
7.4.2. One or more natural or judicial persons or partnerships can be appointed, provided they are registered with the Federal Audit Oversight Authority. The provisions on independence apply by analogy. At least one member of the auditors must be domiciled in Switzerland or have his registered office or a registered branch in Switzerland.
7.4.3. The provisions of the Swiss Code of Obligations regarding external auditors for companies apply accordingly.
7.5.1. The board publishes a report on its activities at least once a year, including (from Association year 2024) an audited annual financial statement.
8.1. The Association is dissolved based on a corresponding resolution.
8.2. In the event of the dissolution of the Association, its assets are to be transferred to a tax-exempt organization in Switzerland that pursues the same or a similar purpose. The distribution of the Association's assets among the members is excluded.