Pursuant to the Art. 13 of the Associations Act (Official Gazette No. 74/14) the Assembly of the Innovative Pharmaceutical Initiative adopted at the meeting held 17 June 2015 the following:
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 acomplishment of publicity of work, goals and activities aimed at acomplishment 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, procedual rules in the event of breach of the Code of Conduct of Innovative pharmaceutical companies (hereinafter: the Code), 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.
Tha abbreviated name of the Association is: IFI.
The Association may use the following sylised 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 organisation established with the following goals:
- to implement and constantly improve 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 healtcare 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“ addopted by the EU member-countries (EU),
- to promote and support the standards and guidelines addopted 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, acces to information and market competition in the field of medicinal products
- to work on factors impairing, by way of limiting, delaying or blocing, patient’s access to proved effective and acceptably tolerable medicinal products
- to achive the permanent contact among its members.
In acomplishment 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
- co-ordinating activities with EFPIA
- developing co-operation with other medicinal product manfuacturers
- raising awareness of non-ethical behavours of pharmaceutical companies which are not members of the Association,
- developing co-operation with professional organisations 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
- co-ordinating the actions of its members aimed at the acomplishment of the above stated goals
- organising meetings for all members of the Association to dicuss particular current issues
- creating and implementing charity projects.
The Association may have regular and honourary 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 contribution.
The written request for the membership in the Association is submitted to the Secretary of the Association who shall forward the request to the Management Board of the Association for rendering decision on admission or rejection of the potential candidate’s request for the membership in the Association, which decision must not contain elaborated reasons and it cannot be contested by any legal remedy.
The member of the Association si represented by the legal represenative or by the proxy (natural person) duly authorised by the legal represenative 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 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.
The list of members is kept by the Secretary of the Association 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 date of stop of the membership status.
The list of members shall be always available for the insight of all members and competent authorities, at their request.
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 acomplishment 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 organised 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.
The obligations of the regular members are:
- support the activities aimed at acomplishment 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 thrid parties
- payment of the admission fee, as determined by the Assembly
- payment of the annual membership contribution as fixed and within the timelines determined by the competent bodies of the Association
- inform the Secretariat of 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 register of the members of the Association,
- inform the competent bodies of the Association on observed irregularities in behaviour 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 behaviour or refused to remedy the consequences of the breach within the timelines determined in the warning letter of the complainant.
The annual membership contribution applicable for each subsequent year and payable by all regular members of the Association in accordance with the relevant payment classes, is fixed – each year simultaneously with the annual budget at the end of the current calendar year – by the Assembly, either at it’s regular or the budgetary meeting.
The proposal of the budget, including the proposal of the amount of the annual membership contribution, 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 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 contribution 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 the meeting of the Assembly or after adoption of the budget or the membership contribution for the forthcoming period it shall, irrespective to the fact of resignation, pay the full amount of the adopted membership contribution in accordance with the relevant payment class.
All regular members of the Association will be provided with the invoices with the adopted amount of the membership contribution and the payment due dates.
The invoice for payment of annual membership contribution, 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 disollution of the company-member of the Association (as declared in the liquidation or bankruptcy process)
- 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 Entitites,
- by death of the honorary member.
The membership in the Association will stop by decision 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 contribution 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 stop on exclusion and the appeal is filed to the Secretary of the Association who shall report the case to the Management Board of the Association with the goal of placing the issue on the agenda of the next Assembly or initializing of the electronic voting of the members of the Assembly on the appeal.
Decisions 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 on legally valid decision of the Ethics Committee i.e. the Assembly declared in the proceedings for the breach of the Code, expelling the member of the Association 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 authorised representative.
The Assemby 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 Assemby are adopted by public voting, except in case of resolutions on election of the governing bodies of the Association which are adopted by secret vote. The Management Board of the Association may decide that the Assembly may adopt resolutions on certain issues electronically, by way of sending the votes or deliberations of the members of the Association to the official e-mail address of the Association.
The Assembly cannot electronically render resolutions on election or revocation of the governing bodies of the Association, adoption of the Statute or its changes, resolutions following proposals for expulsion from the membership in the Association delivered in the procedure for breach of the Code pursuant to the Art. 12 of this Statute and the resolution on Association’s dissolution.
The President of the Associaton 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 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 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 respresentative or by proxy (natural person) duly authorised 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 (thrity) days from the date of receipt of the proposal at its latest.
The proposer 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.
President of the Association or the member of the governing body of the Association whose mandate expired (or if the mandate expired jointly to a certain body of the Association) may continue to perform the tasks of the position for a maximum period of 3 (three) months from the date of expiry of the mandate whereas, in such period, the convening of the Extraordinary Assembly is mandatory.
Minimum ¼ (one-quarter) fo the regular members of the Association may convene the Assembly after the expiry of the mandate of the President of the Assembly or the member 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
- adoption of the action plan and the annual budget
- confirmation of the financial reports and the balance sheet
- election and revocation of the governing bodies of the Association within its own competencies
- fixing the amount of the admission fee and the membership contribution
- expulsion of the member of the Association from the membership in the Association in the events provided in the Art. 10 and 12 of the Statute
- adoption of the particulary important resolutions for the Association
- adoption of the resolution on membership of the Association in the international organisation
- adoption of the dissolution resolution.
President of the Association
The President of the Association is elected by the Assembly for the period of 2 (two) years.
The President of the Association is authorised to represent the Association in line with the provisions of the Associations Act.
If the President is prevented from performing his duties for whatver reasons and circumstances, (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 – natural persons/representatives of the members of the Association with the voting right.
The President of the Association is a member of the Management Board by her/his function, whereas the remaining 6 (six) members will be elected by the Assembly of the Association, also for the period of 2 (two) years.
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 members of the Management Board resigns or is relieved of duty before the expiry of the mandate i.e. if her/his function stops or her/his employment with the company (s)he represents is terminated ((s)he shall inform the Management Board thereof, without delay), the Assembly will elect new member of the Management Board for the period remaining up to the expiry of the mandate of the Management Board member that ceased to be a member of the Management Board.
If the particular Management Board member’s function stops or her/his employment with the company (s)he represents will be terminated for the reason of accepting the management position and employment with the other member of the Association ((s)he shall inform the Management Board thereof, without delay), it will be deemed that her/his mandate had been put at the disposal of the Assembly of the Association who shall render decision whether the respective member should continue to perform his duty of the member of the Management Board or should a new member be elected, in line with the previous paragraph of this Article.
Immediately upon becoming aware of the cases described in the previous two paragraphs of this Article and always where the convening of the Assembly is not foreseen within the next 60 (sixty) days, the Management Board shall determine the date of the next Assembly of the Association aimed at deliberating and rendering decisions on such cases.
The Executive Director shall attend the meetings and sessions of the Management Board, without voting right.
The President of the Management Board or the Executive Director of the Association shall convene the regular meetings minimum once in 2 (two) months, and more frequently when required.
Individual acts, conclusions and decisions passed by the Management Board shall be signed by the President of the Management Board and the Executive Director of the Association.
Written conclusions form the meetings of the Management Board shall be available to all members of the Association.
Decisions of the Management Board will be passed by the simple majority of the attending members, provided that minimum 5 (five) members of the Management Board are present at the meeting.
Exceptionally, the non-attending member of the Management Board may vote electronically, if such manner of voting will be accepted as appropriate by the attending members of the Management Board.
The Management Board has following responsibilities:
- preparation and convening of the Assembly of the Association
- preparation of the drafts of amendments of the Statute, the Code and other acts of the Association
- preparation of the action plan and determination of priorities
- organisation and co-ordiantion of the implementing activities aimed at the realisation of the action plan and the goals of the Association
- preparation of the final budget proposal, balance sheet and the final financial report
- mainatining contacts 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
- deciding about the proposal of the Task Force for Ethics & Compliance on expulsion from the membership in the Association withinin the frame of the process of sanctioning of the member within the meaning of the Art. 24 of this Statute in case of breach of the Code
- 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 where no complaint of any other member of the Assocation or any interested party outside the Association’s membership had been filed
- disposing with the financial assets of the Association
- proposing the Assembly the amount of the annual membership contribution and its maturity
- deciding about the amount of the 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
- establishing the task forces and working bodies of the Association to aimed at more efficient and goal-reaching performance
- establishing the Secretariat of the Association, as the administrative service of the Association
- appointing and recalling the Associations’ liquidator
- deciding on other issues which are not decided by the Assembly.
The Management Board is acountable for it’s 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 acountable for her/his work to the Management Board of the Association.
The Executive Director is elected by the Management Board, subject to pre-defined qualificatory 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 bodies responsible for the enforcement procedure mentioned in the paragraph 1 of this Article are Ethics Committee – in the first instance and the Assembly of the Association – in the second instance.
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 immediatelly 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 a Secretariat responsible for the administrative tasks.
Secretariat of the Association is run by the Associations’s Secretary and the Management Board of the Association enters into the employment or other appropriate agreement with such person providing for the rights and obligations with respect to performance of the said position.
Secreatariat may have other employees or associates.
Secretary of the Association is responsbile for administative operation of the Association, (s)he attends the meetings of the Management Board, the Assembly and, if required, other bodies of the Association and (s)he is acountable for her/his work to the Management Board of the Association.
The specific duties of the Secretary of the Association with respect to the Code-enforcement process are provided in the respective provisions of the Code.
The Secretariat of the Association has following responsibilities:
- keeping the list and register of the members of the Association
- following-up of the material-financial aspect of Association’s business
- distributing letters and mail to the members of the Association
- performing other tasks, at the instruction of the Management Board.
The Association has following dedicated task forces:
- Medical & Regulatory
- Public Affairs
- Pricing & Reimbursement
- Ethics & Compliance
- Strategic Initiatives
- Finance & Tax
The Management Board of the Association renders decision on the composition, manner of work and other issues related to the work of taks forces mentioned in the previous paragraph.
For the purpose of more efficient work of the Association, the Management Board may establish another taks forces and working bodies.
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 authorisation of the President of the Association.
The Association’s assets comprises from financial assests, movable properties, rights and obligations.
The financial assets are following:
- admission fees, as determined by the Assembly of the Association
- annual membership contributions, as determined by the Assembly of the Association
- fee for conduct of Code-enforcement proceedings before Ethics Counsil – in the first instance and the Ethics Committee – in the second instance,
- 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 authorised 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 President of the Association or other person appointed by the Management Board shall act as liquidator.
This Statute had been adopted by the Assembly at the meeting held 17 June 2015 and its shall enter into force as of the date of its adoption.
PRESIDENT OF THE ASSOCIATION