The Assembly of the Innovative Pharmaceutical Initiative adopted at the meeting held June 10, 2021 the Decision on Amendments of the Statute and empowered the Management Board of the Innovative Pharmaceutical Initiative to lay down the Consolidated Statute, as follows:
Statute of the Innovative Pharmaceutical Initiative
This Statute is a basic act of the association Innovative Pharmaceutical Initiative (hereinafter: the Association) providing for the name, registered seat, field of activity, the manner of accomplishment of publicity of work, goals and activities aimed at accomplishment of goals, membership, governing bodies of the Association, their composition, election, recall, authorities, decision-making process and the duration of their mandate as well as the manner of summoning of the Assembly in the event of expiry of mandate, representation of the Association, dissolution of the Association and the election and recall of the Association’s liquidators, as well as other matters relevant for the functioning and activities of the Association.
The Association is a legal person and its activities are based on the voluntary contributions of its members.
The Association is non-profit and independent.
The Association is a member of the European Federation of Pharmaceutical Industries Associations (hereinafter: EFPIA) of Bruxelles.
The Association may be the member of other international organizations.
The work of the Association is public.
Publicity of work of the Association is achieved by permanent contacts and co-operation among its members, timely reporting of the membership on the work of the Association, rendering information by use of the website of the Association as well as the co-operation of the Association with public authorities and institutions, healthcare associations and by periodical publications.
The Association is named: INOVATIVNA FARMACEUTSKA INCIJATIVA.
The Association uses the name in English language: Innovative Pharmaceutical Initiative.
The abbreviated name of the Association is: IFI.
The Association may use the following stylized form of its abbreviation for the official purposes: iF! and in line with the leased Internet domain: ifi.hr
The registered office of the Association is in Zagreb.
The Management Board of the Association will choose the business address of the Association and it’s changes by a decision.
The Association performs its business on the entire territory of the Republic of Croatia.
The Association is voluntary and autonomous organization established with the following goals:
– to implement and constantly improve the Code of Conduct of Innovative Pharmaceutical Companies in Interactions with Healthcare Professionals, Healthcare Organizations and Patient Organizations (hereinafter: the Code),
– to create beneficial economic, administrative and political environment with the objective of enabling the innovative pharmaceutical industry to meet the growing needs for healthcare and patient’s expectations,
– to promote and support good manufacturing and good laboratory practices as pre-requisite of securing adequate quality of medicinal products, principles of good clinical practice as pre-requisite for protection of patient’s interests and ethical conduct of clinical trials, as well as any principles of any „good practices“ adopted by the EU member-countries (EU),
– to promote and support the standards and guidelines adopted by the EU member-countries providing for regulatory affairs, distribution, administration, quality controls and reimbursement of medicinal products by competent state authorities and institutions,
– to actively participate in the legislative process (creation of laws, by-laws and other acts governing in the field of medicinal products)
– to support innovation, protection of intellectual property, access to information and market competition in the field of medicinal products
– to work on factors impairing, by way of limiting, delaying or blocking, patient’s access to prove effective and acceptably tolerable medicinal products
– to achieve the permanent contact among its members.
In accomplishment of its goals determined in the Art. 5 of this Statute, the Association shall engage in the following activities:
– promotion and control of compliance with the Code by its members and taking appropriate procedures against the perpetrators in the event of breaches of the Code;
– developing co-operation with the ministry for health in the Republic of Croatia and other authorities and institutions in the field of medicinal products and proposing legislative acts in the field of medicinal products
– coordinating activities with EFPIA
– developing co-operation with other medicinal product manufacturers
– raising awareness of non-ethical behaviors of pharmaceutical companies which are not members of the Association,
– developing co-operation with professional organizations involved in the field of the health care and social care, funds for additional, supplemental and private health insurance
– constantly and timely providing its members with important information and representing their interests
– drawing attention to non-standard, low-quality and non-adequate medicinal products
– coordinating the actions of its members aimed at the accomplishment of the above stated goals
– organizing meetings for all members of the Association to discuss particular current issues
– creating and implementing charity projects.
The Association is active in the field of economy, pharmaceutical industry.
The Association may have regular and honorary members.
The regular member of Association may become any innovative (research-based) medicinal product manufacturer who performs its activity in the Republic of Croatia through its affiliated company or registered representative office in the Republic of Croatia, subject to his written statement of acceptance of this Statute and the Code and payment of the admission fee and the annual membership fee.
The member of the Association is represented by the legal representative or by the proxy (natural person) duly authorized by the legal representative of the respective member i.e., the legal representative of the representative office.
Exceptionally, the regular member of the Association may become company registered in the Republic of Croatia acting as a representative of one or more innovative medicinal products manufacturers.
The admission request with elaborated reasons for acceptance shall be made as written request submitted to the Association.
The admission decision (positive or negative) mentioned in the previous paragraph will be passed by the Management Board of the Association, whereas such decision should not provide reasons and it cannot be contested by any legal remedy.
Written statement on acceptance of the Statute and the Code by new member is condition for admission to the membership, upon positive admission decision of the Management Board.
The list of members is kept in electronic format and it comprises of the following minimum information: the name of the member, personal identification number (OIB), date of admission, category of the membership and the membership end date.
The list of members shall be always available for the insight of all members and competent authorities, at their request, at the premises of the Association.
The Assembly or the Management Board of the Association may propose honorary membership to any natural person who, in their judgement, significantly contributes or may contribute to the accomplishment of the goals of the Association. Potential honorary members are appointed by the Management Board.
The membership of the appointed honorary member is subject to candidate’s acceptance.
The rights of the regular and honorary members are:
– participation at all activities and events organized by the Association,
– use of the information gathered by the Association.
Regular members have voting rights at the meetings of the Assembly and the right of co-deciding on all issues related to the activities of the Association, as well as the right of elect and being elected in the governing bodies of the Association.
Honorary members have right of participation in the work of the Assembly, without voting rights and have no duty of payment of admission fee and membership fee.
The obligations of the regular members are:
– support the activities aimed at accomplishment of Association’s goals
– active participation in the activities of the Association
– respect confidentiality of all aspects of the Association’s business and refrain from disclosing confidential information to third parties
– payment of the admission fee, as determined by the Assembly
– payment of the annual membership fee as fixed and within the timelines determined by the competent bodies of the Association
– inform the Association about any material changes and the change of the person occupying the position of the legal representative of the member, for the purpose of collecting and up-dating valid data relevant for the List of the members of the Association,
– inform the competent bodies of the Association on observed irregularities in behavior of the members of the Association colliding with the provisions of this Statute or the Code of Association
– filing complaints against the member of the Association to competent bodies of the Association in the events of becoming aware of the reasonable doubts on occurrence of the breach of the Code or if the respective member of the Association refused to cease with the Code-breaching behavior or refused to remedy the consequences of the breach of the Code stated in the warning letter of the complainant.
The annual membership fee applicable for each subsequent year and payable by all regular members of the Association in accordance with the relevant payment classes, is fixed on annual basis – simultaneously with the annual budget by the Assembly, either at its regular or the budgetary meeting.
The proposal of the budget, including the proposal of the amount of the annual membership fee, shall be electronically provided to the regular members in advance i.e., prior to the meeting of the Assembly and all members may respond to the proposal within the timelines provided in the side electronic letter.
Upon expiry of the timeline for responses, the Management Board shall make a final draft of the budget proposal and the amount of the membership fee for the next calendar year and shall put both proposals on the agenda of the Assembly.
In the event that any regular member of the Association resigns from the membership in the Association at its own initiative after the Management Board adopted the final proposal of the budget and the membership fee for the forthcoming period but before convening of the budgetary Assembly and providing that such member of the Association failed to submit objections against such proposal, the resigning member of the Association shall pay the full amount of the adopted membership fee in accordance with the relevant payment class, irrespective to resignation from membership.
All regular members of the Association will be provided with the invoices with the fixed amount of the membership fee and the payment due dates.
The invoice for payment of annual membership fee, as charged by the Association to the regular member, represents enforceable deed in the sense of the Enforcement Act.
The membership in the Association will stop:
– at the member’s own written request
– by dissolution of the company-member of the Association (as declared in the liquidation or bankruptcy process, dissolution of the company or deletion from the company register)
– by deletion of the representative office-member of the Association as declared by the decision of the competent ministry of the Republic of Croatia on deletion of the representative office from the Register of the Representative Office of Foreign Entities,
– by death of the honorary member.
The membership in the Association will stop by decision on exclusion of the Management Board in the event that the member of the Association violates the provisions of the Statute or other decision adopted by the governing bodies of the Association e.g., in case of non-payment of the membership fee despite repeated warnings, in cases of evident long-lasting inactivity of the member and similar.
The excluded member has a right of appeal to the Assembly within 15 days from the date of receipt of the decision on exclusion and the appeal is filed to the address of Association’s registered office. The Management Board shall include the appeal in the agenda of the next Assembly aimed at rendering decision on the appeal and in case the next Assembly is not determined within 60 (sixty) days from the day of receipt of the appeal, the Management Board is obliged to determine the date of the Assembly within the next 90 (ninety) days.
Decision of the Assembly passed in application of the paragraph 3 of this Article cannot be contested in the administrative lawsuit.
The membership in the Association will stop by the decision on exclusion of the Assembly in case of imposing a sanction reading as follows: “proposal to the Assembly on expelling of the member from the membership in the Association” in line with the provisions of the Code.
Decisions passed in application of the paragraph 1 of this Article cannot be contested in the administrative lawsuit.
The governing bodies of the Association are:
• Management Board
• Executive Director
Assembly is the highest governing body of the Association. The Assembly is comprised of all regular members of the Association represented at the meeting of the Assembly by one authorized representative.
The Assembly adopts decisions by majority of votes of present members with the voting right and the meeting may be held only if at least one/half (1/2) of the members with voting right are present. Each regular member of the Association has one voting right in the Assembly of the Association.
As a rule, the resolutions of the Assembly are adopted by public voting, except in case of resolutions on election of the governing bodies of the Association which are adopted, as a rule, by secret vote. Before convening of the meeting of the Assembly, for reasons of implementing epidemiology measures or other justified reasons, the Management Board of the Association may decide that the participation of the members at the meeting and in the decision-making process at the respective meeting of the Assembly shall be made by use of electronic means, minding the rules on quorum and required majority for rendering decision defined in the previous paragraph of this article.
Except in case provided in the previous paragraph, as a rule, the following decisions of the Assembly shall not be made electronically: decision on election and revocation of the governing bodies of the Association and decision on proposal for expulsion from membership in the Association made in line with the Code, as provided in the Art. 12 hereto.
The President of the Association will chair the meetings of the Assembly.
Exceptionally, the role of the chairman of the meeting may be delegated to the members of the Management Board, only if the President of the Association will be prevented from attending the respective meeting.
The regular meeting of the Assembly will be convened by the President of the Association, following prior decision of the Management Board to that effect, minimum once each year whereas the Election Assembly will be convened each two years.
The Assembly will be convened electronically, by sending written invitations to its members or by e-mails sent at the official e-mail address of the member of the Association, as reported in the “Association’s Membership List”; the invitation must comprise the proposal of the agenda and it will be delivered to the members minimum 14 (fourteen) days prior to the planned date of the meeting.
Each regular member of the Association will be represented at the meeting of the Assembly by its legal representative or by proxy (natural person) duly authorized by the legal representative of the company or by the legal representative of the representative office.
The legal representative or proxy from the previous paragraph may represent only one regular member of the Association and vote for such member at the meeting of the Assembly.
The Election Commission which will be elected by the attending members of the Assembly to run the elections at the Election Assembly, such Commission consisting of minimum 2 (two) members.
The Election Commission determines the candidates for the governing bodies of the Association, conducts the elections, supervises their legitimacy, counts votes and declares the results of voting.
The extraordinary Assembly must be convened by the President of the Association always when requested by minimum ½ (one-half) of the regular members of the Association (proposers), within 30 (thirty) days from the date of receipt of the proposal at its latest.
The proposers mentioned in the previous paragraph, propose the agenda in the proposal.
If the President of the Association does not convene the Extraordinary Assembly of the Association in line with the previous two paragraphs of this Article, proposers designated in the paragraph 2 of this Article are entitled to convene such meeting by way of sending the members of the Association written invitations stating the time, the place and the agenda of the meeting.
In the event of expiry of mandate to the governing bodies of the Association, the meeting of the Assembly may be convened by the legal representative registered at such moment in the Register of Associations or minimum ¼ (one-quarter) of the regular members of the Association registered with the List of members of the Association at the moment of the expiry of the mandate of the governing body of the Assembly.
The Assembly of the Association has following responsibilities:
– adoption of the Statue and its amendments
– adoption of the Code and other codes of ethics
– validation of the minutes from the previous meeting of the Assembly
-adopts the annual financial report
– adoption of the action plan and the annual budget and the balance sheet for a following calendar year
– adopts the report on the work for the period from the previous Regular Assembly
– election and revocation of the governing bodies of the Association within its own competencies
– fixing the amount the membership fee
– expulsion of the member of the Association from the membership in the Association in the events provided in the Art. 11 and 12 of the Statute
– adoption of the particularly important resolutions for the Association
– adoption of the resolution on membership of the Association in the international organization
– adoption of the dissolution resolution.
Elections for the bodies of the Association
Elections for the bodies of the Association, i.e., for the members of the Management Board and the President of the Association are held at the Electoral Assembly of the Association.
Prior to the Electoral Assembly, candidates for members of the Management Board of the Association are nominated by members of the Association by invitation to the Electoral Assembly of the Association, which will indicate the appropriate deadline for the nomination of candidates.
In case of exceeding the deadline from the previous paragraph, the nomination will not be recognized.
Only one candidate from each of the members of the Association can be nominated for a member of the Board of Directors (preferably the director of the company and / or another high-ranking person in the company), who can only be nominated by the parent member.
Upon expiration of the deadline for nomination of candidates, all members will be notified of the nominated candidates.
The received candidacies and the list of candidates will be checked and verified by the Election Commission referred to in Article 16 of this Statute.
In the event that less than seven candidates are nominated by the deadline for nomination, the Management Board will decide to postpone the Electoral Assembly and set a new date for the Electoral Assembly, and repeat the procedure with new deadlines for nominating candidates for the Association.
At the session of the Electoral Assembly, only one authorized representative of an individual member of the Association from Article 15 of this Statute has the right to vote, to whom a ballot paper will be distributed, based on which he will vote for exactly seven candidates from all candidates determined by the candidate list.
Seven candidates with the most votes become members of the Managing Board of the Association for the next two-year term.
In case that two or more candidates with the largest number of votes have the same number of votes, the voting will be repeated only for those candidates, in order to elect a person who has the right to accept the position of President of the Association.
In case that two or more candidates with the lowest number of votes qualifying as a member of the Management Board have the same number of votes, the voting will be repeated only for those candidates, in order to get exactly seven members of the Management Board.
In case of an unfavorable epidemiological situation, the session of the Electoral Assembly will be held electronically, and the secrecy of voting during the elections for the bodies of the Association will be ensured through a public notary or in another appropriate and technically feasible way.
The President of the Association is elected by the Assembly for the period of 2 (two) years, as the person who wins the most votes at the Electoral Assembly during the election for members of the Management Board of the Association
The President of the Association is authorized to represent the Association in line with the provisions of the Associations Act.
If the President is prevented from performing his duties for whatever reasons, (s)he will be replaced by the vice-president of the Management Board of the Association and the Executive Director of the Association.
The President of the Association is also the President of the Management Board of the Association and preforms his duties in line with the guidelines of the Assembly and the Management Board of the Association and accounts for his work to the Assembly of the Association.
The Management Board is executive body of the Association comprising of 7 (seven) members of the members of the Association with the voting right.
Members of the Board of Directors are elected by the Assembly of the Association, for a period of two years, with the person winning the most votes becoming the President of the Association, if accepted, and otherwise, the right to accept the position passes to the next member of the Board votes and so on.
The members of the Management Board shall elect the vice-president of the Management Board at the constitutive meeting of the Management Board.
If any of the members of the Board of Directors resigns or is dismissed before the expiration of the term, or if his employment with the parent company he represents is terminated or is employed in the member from which the member of the Board of Directors in the current term of office, without delay), the Assembly shall elect to the Governing Board another person for the remaining period until the expiration of the term of office of the member whose membership in the Governing Board has ceased.
Upon learning of the cases from the previous two paragraphs of this article, if it is not planned to hold a regular Assembly of the Association within the next 60 (sixty) days, the Board is obliged to set a date for the Assembly of the Association to discuss and decide on these cases.
Meetings of the Managing Board are attended by the Executive Director of the Association, but he does not have the right to vote.
The President of the Managing Board or the Executive Director of the Association convene regular meetings at least once in 2 (two) months, and if necessary, more often. Meetings can be held electronically.
Individual acts, conclusions and decisions, issued by the Managing Board, are signed by the President of the Managing Board of the Association. Official letters sent by the Association to third parties are usually signed by the Executive Director of the Association, and protocol letters are signed or co-signed by the President of the Association.
Written conclusions from the meetings of the Managing Board are delivered to all members of the Association.
At the meeting of the Managing Board, the decision is made if at least 5 (five) members vote for it, provided that the meeting or electronic meeting is attended by at least 5 (five) members of the Managing Board of the Association. The majority, if not all decisions, will be made by an absolute majority, i.e., by the vote of all members of the Managing Board of the Association.
Exceptionally, a member of the Management Board who is absent from a meeting that is not held electronically, may participate and give his vote electronically, if it is deemed appropriate by the present members of the Management Board.
The Management Board has following responsibilities:
– preparation of the Assembly of the Association and decision on the date of the Assembly
– preparation and adoption of final proposals of the Statute, the Code and other acts of the Association, their amendments and consolidated texts
– makes decisions, conclusions and other acts that are not within the competence of the Assembly and decides on the need to regulate certain segments of the Association and improve the activities of the Association through rules of procedure and other implementing acts
– preparation of the action plan and determination of priorities
– organization and coordination of the implementing activities aimed at the realization of the action plan and the goals of the Association
– prepares and adopts the final budget proposal and confirms the official financial reports prepared by the Association’s accountant
– proposing the Assembly the amount of the annual membership and its maturity
– deciding about admission fee for the new members of the Association
– determining the need for additional raising of funds for financing of extraordinary activities of the Association and the necessary amounts of such funding
– maintaining contact with the ministry of health and other competent authorities in the field of medicinal products and informing the members of the Association on important resulting information and news;
– deciding about the admission of the new members of the Association and exclusion of the existing members of the Association
– warning competent authorities of the Association, in line with the Code, on any cases of doubt on existence of the breach of the Code by any member of the Association
– disposing with the financial assets of the Association
– establishing the task forces and working bodies of the Association to aimed at more efficient and goal-reaching performance
– deciding on the need of employing in the Association
– appointing and recalling the Associations’ liquidator
– deciding on other issues which are not decided by the Assembly.
The Management Board is accountable for its work to the Assembly.
The Executive Director of the Association is, as a rule, a professional and a main operative of the Association who represents the Association towards third persons and who is accountable for her/his work to the Management Board of the Association.
The Executive Director is elected by the Management Board, subject to pre-defined qualificator criteria which must be met by potential candidates for this position.
Simultaneously with the election of the Executive Director, Association shall enter into the employment agreement or any other agreement providing for the mutual rights and obligations with respect to performance of the said position.
The mandate of the Executive Director of the Association shall last until revocation by the Management Board of the Association.
The procedure of enforcement of the Code on the account of the alleged breaches, the constitution and the authorities of the enforcement bodies and the sanctions that may be imposed against the accused member of the Association are provided in detail in the Code.
The Code guarantees the right of appeal against the decisions of the enforcement bodies of the first instance passed in the process for the breach of the Code.
All disputes among the members of the Association with aggravating or precluding effect to the functioning of the Association, other than disputes arising for the breach of the Code in the sense of the Art. 24 of the Statute, will be resolved by the members of the Association in an amicable manner. If an attempt to resolve the dispute amicably fails, the dispute will be submitted to the materially competent court of Zagreb.
Member of the Association shall, in all his actions of the interest and importance for the Association, act conscientiously, diligently, responsibly and impartially, minding the credibility and the reputation of the Association. The member of the Association shall not put his own interests before the interests of the Association.
The member of the Association shall be in the conflict of interest if, in any individual case, his own interest is contrary to the interest of the Association or in the event where the individual interest influences or may be influencing the impartiality of the member of the Association in performance of Association’s business. The member of the Association who becomes aware of the conflict of interest shall immediately inform the Management Board of the Association thereof and, if possible, refrain from further work on the concrete activity.
In all cases of doubt of the existence of the conflict of interest, the member of the Association shall revert to the Management Board for the opinion.
The Association has following task forces, which are financed from the regular budget of the association:
TF for registration, clinical trials, medical work and pharmacovigilance
TF for affairs related to the medicine’s list
TF for Ethics & Compliance
TF for Finance & Tax
TF for Cooperation with Patient Organizations
The Management Board of the Association may also establish specialized professional sections funded exclusively by interested members who apply to participate in such a section.
The Management Board of the Association renders decision on the composition, manner of work and other issues related to the work of task forces mentioned in the first paragraph.
For the purpose of more efficient work of the Association, the Management Board may establish another task force, working groups and working bodies of the Association.
The Management Board may establish a Strategic Council to which invites representatives of unrepresented members of the Board of Directors, who may contribute to the creation and implementation of specific strategic plans and policies of the Association.
The Strategic Council operates through meetings held as meetings of the enlarged Management Board and through special workshops
The President and the Executive Director of the Assembly represent the Association.
The powers of representation of the Association can be delegated to third persons subject to special authorization of the President of the Association.
The Association’s assets comprise from financial assets, movable properties, rights and obligations.
The financial assets are following:
– admission fees, as determined by the Assembly of the Association
– annual membership fee, as determined by the Assembly of the Association
– assets collected in the process of collecting of fines imposed in the Code-enforcement proceedings,
– donations and other revenues received in line with special laws.
Financial assets of the Association shall be managed on the unique bank giro account.
Available financial assets will be used for the regular activities of the Association.
The Management Board will manage the assets of the Association and is responsible for the financial and material business, allocations and spending of the financial assets.
The President of the Association and the person duly authorized by the President will have decisive powers with respect to the disposal with the Association’s assets.
In the event of the dissolution of the Association, upon settlement of claims of all creditors and any costs, the remaining assets of the Association shall be given to the association, institution or foundation with the same or the similar statutory goals, following the resolution of the Assembly in line with the Statute.
The Management Board of the Association elects the liquidator who will be in charge of the liquidation process within 60 (sixty) days from the date of receipt of the official decision of the competent authority on opening of the liquidation process.
This Statute was adopted by the Assembly of the Association at its session held on June 17, 2015, which was amended by the Statutory Decision on Amendments to the Statute of September 24, 2020 and the Statutory Decision on Amendments to the Statute of June 10, 2021 and as such shall become effective as of June 10, 2021
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The President of the Association