April 2015 Dear Full Members Last year the Executive Board took a hard look at the Association’s Statutes and realised that they were no longer aligned with our Strategic Plan and did not reflect the way the Association works in today’s industry. A Working Party was appointed to overhaul the Statutes: James Rienow, Pfizer and former Board member Michel Bruguiere Fontenille, Treasurer Bernadette Rogers, General Manager ….….and a series of telecons took place to discuss the direction the Statutes should take and how to bring them up to date and as future proof as possible. The Executive Board was also consulted on key points and important changes. The result is this document which in the left hand column shows the current statutes and the right shows the proposed new text. Sections have been streamlined and duplication erased, terminology updated and additions made to future proof the Statutes so as to avoid having to regularly ‘tweak’ the statutes. So the Executive Board would now like to invite pharma members to review the proposed new Statutes and provide any input prior to finalisation and then voting. Such a major change warrants this period of consultation. You can either send your comments by email or comment in this document and email it back to generalsecretary@ephmra.org Deadline for comments is 12 May. Many thanks Executive Board 1 Current statute wording Association Européenne des Etudes du Marché Pharmaceutique Europäische Vereinigung für Pharmazeutische Marktforschung Associazione Europea per lo Studio del Mercato Farmaceutico with its registered office in Basel Proposed new wording No longer to be included. I. Name, registered office, duration and purpose of the Association 1.Name, registered office, duration and purpose of the Association Art. 1 Name and registered office An association entitled the European Pharmaceutical Market Research Association exists within the meaning of Art. 60ff. of the Swiss Civil Code. The Association is established without limit of time. The Association, with its registered office in Basel, also has a Gmbh entity which is also registered in Basel. An association entitled the European Pharmaceutical Market Research Association (Association Européenne des Etudes du Marché Pharmaceutique, Europäische Vereinigung für Pharmazeutische Marktforschung, Associazione Europea per lo Studio del Mercato Farmaceutico) exists within the meaning of Art. 60 ff. of the Swiss Civil Code. The Association is established without limit of time. The registered office of the Association is in Basel. Article 1 above: It was decided to omit the translations above, thus making it streamlined. Art. 2 2.Purpose, Mission and Objectives Purpose EphMRA’s overall aim is to create an environment that encourages excellence for international healthcare market researchers to provide insights based on state-of-the-art market research activities combined with business knowledge. 1. The purpose of the Association is to develop and improve standards and techniques in Europe for market research in the field of health and healthcare, and to strengthen the role of the Association in the relevant decision-making processes in order to support its members in their international activities and to create transparency to the general benefit. The efforts made, and activities engaged in, by the Association in order to achieve this purpose include, but are not limited to, the following: 2. The efforts made and activities engaged in by the Association in order to achieve this purpose include, but are not limited to, the following: a) Promoting the exchange of experience and innovative methodological fundamentals among individual members in the field of pharmaceutical 2 Driving the development of best practices in international healthcare market research. market research. This exchange must be based on the principle of reciprocity. In addition to meetings of the Association, special working sessions can be arranged if required; b) Maintaining contact with related market-research organisations in order to facilitate improvements in existing studies and to ensure that they can participate in decision-making in special studies as well as regular scheduled studies; c) The development of internationally valid standards in the field of anatomical classification; d) The establishment and maintenance of cooperative arrangements and partnerships with other relevant associations in other countries and fields of activity, especially (but not solely) with the World Health Organisation (WHO); e) Cooperation with the not-for-profit sister organisation "PBIRG Pharmaceutical Business Intelligence Research Group" in the United States of America; f) Taking focused measures to promote the training of the next generation of senior managers of individual members. 3. It is the Association‘s objective to be as market-neutral as possible. a) The Association does not engage in profit-making activity. Measures to promote the training of the next generation of senior managers can either be organised by a special legal entity or entrusted to third parties. b) The Association does not act as a service provider in the market except as an umbrella organisation. However, this does not prevent the Association from declaring its patronage of activities designed to further its objectives, issuing guarantees or openly assuming the role of sponsor. 3 Promoting the exchange of experience, best practice and innovative methodological fundamentals among members. Developing internationally valid standards in the field of international healthcare market research, like the anatomical classification for pharmaceutical products. Establishing and maintaining co-operative arrangements and partnerships with other relevant associations in related fields of activity. Article 2 was reviewed so as to make the purpose etc fit for the future and better reflecting the Associations direction. Many of the references and detailed comments were eliminated as well as detailed references to training – these being covered in the bullets by implication. Too much detail was felt to tie us in for future deliverables which may or may not be appropriate, whereas flexibility was considered better. II. Membership 3.Membership Art. 3 Full Members EphMRA offers these membership categories: 1. Full membership is open to companies, universities and technical colleges that are active in the fields of pharmaceuticals or healthcare, provided that they meet the following preconditions: Full Membership Associate Membership Academic Membership Affiliate Membership a) The company must regularly conduct multinational market research and / or business monitoring, and exercise an international market-research function; The membership process is available on the EphMRA web site. 1.Full Membership: Qualifications and Voting b) The company must furthermore conduct medical research and development on a regular basis in the pharmaceutical, medical-technology or diagnostic fields, or be involved in the international marketing of products in these fields. The company must conduct research and development and/or market products or services in the healthcare, medical-technology or medical diagnostic fields. By company is meant a legal entity and all its companies and subsidiaries irrespective of name. c) The university or technical-college institution must be active (and have a professorship) in the pharmaceuticals field or in the development of medical equipment and diagnostic procedures or in market research in the healthcare field. The company must undertake multinational market research such as primary research, secondary data analysis or market monitoring. Provided that the aforementioned conditions are met, the ownership of the said companies need not necessarily affect membership. It is thus possible for more than one full member to have the same owner. Full Members have full voting rights e.g. Full Members’ Business Meeting, special interim elections, statute changes, budget approval, election of governing officers. 2. The Board of the Association (see Article 7 infra) considers all applications for membership as soon as the applicant has submitted all the requisite application / documentation demonstrating that it fulfils the aforementioned admission criteria. The application will be processed at the next meeting of the Board of the Association or by email as appropriate. Provided that all the aforementioned preconditions have been met, the application may then be approved by the Board. Each Full Member company will have only one vote. 2.Associate Membership: Qualifications and Voting The company must be engaged in market research and/or business monitoring relating to healthcare, medical-technology or medical diagnostic fields. 4 The Board can approve, decline, withdraw or suspend membership. Membership is confirmed once accepted by the Board and full members notified. Confirmation of membership can be revoked with the consent of at least one third of existing full members within four weeks of the date of election to membership. Associate membership is corporate covering all offices and the HQ office, with the same company name Associate Members have different voting rights to Full Members. Associate Members can vote when indicated by the Executive Board. Associate Members cannot take part in Full Members’ Business Meetings or other Full Member designated meetings. 3. Full members pay an annual membership contribution. The amount of the membership contribution is fixed at the annual meeting of the Association (see Article 6 infra). Membership commences when the annual membership contribution is paid. Membership is automatically renewed after one year unless there is an exceptional case within the meaning of Article 3 nos. 6 and 7. 3.Academic Membership: Qualifications and Voting The Board may offer Academic Membership to universities or faculties. Academic Members have different voting rights to Full Members and Associate Members. Academic Members can vote when indicated by the Executive Board. Academic Members cannot take part in Full Members’ Business Meetings or other Full Member designated meetings. 4. Membership entails the responsibility to cooperate in matters related to market research and business monitoring. Furthermore individual members are expected to play an active part in at least one working group, committee or national group, or on the Board. 4.Affiliate Membership: Qualifications and Voting The company should be active in a non-market research business where a focus of the activity is in healthcare, medical-technology, diagnostics, and complements the aims and activities of EphMRA. 5. Art. 75a of the Civil Code provides that only the assets of the Association are liable for its debts. Personal liability on the part of individual members is limited solely to their membership contributions. Affiliate Members have different voting rights than other members. Affiliate Members can vote when indicated by the Executive Board. Affiliate Members cannot take part in Full Members’ Business Meetings or other Full Member designated meetings. 6. Repeated non-observance of the statutes, conduct contrary to the objectives of the Association or the loss of any of the membership qualifications as set out in Art. 3 no. 1 supra may lead to exclusion from the Association and to loss of membership. Such exclusion must be approved by at least two thirds of the full members at a meeting of the Association. 5.Membership The Executive Board, by majority vote of a quorate Board, can approve, decline, withdraw or suspend any membership. A rationale for the Executive Board decision will be provided. 7. Individual members wishing to resign from the Association must give six months’ notice in writing of their intention to do so. Notice must be submitted to the President of the Association. Resignation takes effect at the end of the relevant fiscal year. 6.Membership Fees Art. 4 Associate Members - all membership fees are set by the Full Members on the Executive Board - companies first have their membership confirmed, then the invoice is issued and when the invoice is paid in full the membership benefits commence - membership is automatically renewed each year unless notice to leave is given. 1. Associate membership is open: 5 a) to any juridical person with an international orientation engaged in market research and/or business monitoring relating to health and healthcare; 7.Notice to leave the Association Full/Associate/Academic/Affiliate Member companies can give notice to leave the Association prior to the end of the membership year by email to the General Manager. Membership will then cease on 30 September. b) colleges and universities; c) companies pursuing additional business activities such as staff recruitment, though it is a precondition that the main focus of their activity must lie in the field of health, healthcare or business monitoring. If such notice is not received before 30 September, membership is automatically renewed and the membership fee for the entire membership year is payable. If the invoice is not paid by the due date the member company is unable to participate as a member until the membership invoice is paid. 2. Associate members are subject to the same provisions regarding approval/admission, resignation, exclusion and liability for the debts of the Association as full members in accordance with Art. 3 supra. 8. Liability Liability on the part of members is limited solely to their membership contribution. 3. Associate membership confers the right to attend meetings and general meetings of members, but not to vote or take part in elections. 4. Insofar as a company or juridical person is admitted to associate membership, it is admitted under its own name and address. Branch offices of the company must accordingly submit separate applications for membership. The membership section has been streamlined and brought together for easier comparison and the membership categories defined and aligned. 2 new membership categories are proposed: affiliate and academic. An example of those who can join in Affiliate membership are staff recruitment, translation agencies and we can put this on the web site Art. 5 The Bodies of the Association 4.Governance and Executive Board The governing bodies of the Association are: The bodies of the Association are: 1. Full Members’ Business Meeting 2. Executive Board a) the General Meeting b) the Board 6 c) individual committees, working groups, national groups d) the auditors. 1.Full Members’ Business Meeting A Full Members’ Business Meeting is held at least once per calendar year and can also be convened at other times if at least one fifth of the Full Members call for it. Art. 6 General Meeting The Full Members’ Business Meeting holds elections and passes resolutions by a simple majority of votes cast (in person, by proxy or other appropriate means) unless the law or the Statutes of the Association prescribe a qualified majority. 1. The General Meeting is held at least once a year. The venue and date are determined by the Board. A General Meeting must also be convened if at least one fifth of the full members call for it. Full Members can bring to the Executive Board’s attention any matters of relevance to the Association. A substantiated matter proposed by a Full Member can be put to Full Members for resolution on the suggestion of at least two Full Members. The General Meeting is the annual assembly for all full and associate members. In addition so-called "business sessions" can be held in individual committees, as well as other meetings that are required for the activity of the Association. 2.Executive Board Secret votes are held at the suggestion of the President or at least three full members. Responsibilities It is the responsibility of the Executive Board to oversee all activities of the Association serving to achieve its objectives. Including, but not limited to: The Board is entitled to hold a closed meeting of full members if it deems this necessary. 2. The General Meeting holds elections and passes resolutions by a simple majority of votes present unless the law or the Statutes of the Association prescribe a qualified majority. Where elections and votes are conducted in writing, a simple majority of the votes received is sufficient. 3. Resolutions can also be proposed in writing. A substantiated matter proposed by a member can be put to full members for resolution on the suggestion of the President or at least three full members. 4. The President has a casting vote in elections and ballots unless the relevant matter concerns him personally. 5. The General Meeting is entitled to elect the President and the Vice-President for the coming term of office (1 October of the year in which the election is held to 30 September of the following year). Neither the President nor the Vice-President may be elected for more than four successive terms of office. Confirmation in office for 7 Reviewing and agree the Association budget for Full Membership approval. The Full Membership approval of the annual financial statements also constitutes ratification of the actions of the Board Setting of Annual Conference and Full Members’ Business Meeting venue and date Approve, decline, withdraw or suspend any membership. A rationale for the Executive Board decision will be provided. Forming and dissolving committees and working groups in order to further the aims of the Association. Appointing interim President and/or Vice President if no nominations received for President or Vice-President or if no candidates are elected by the Full Members. Representing the Association vis-a-vis the outside world Taking account of any matter raised by Full Members and any recommendations made by them. the following term requires a simple majority of the votes present. Nominations for the office of President and Vice-President must be circulated to members at least four weeks before the relevant General Meeting. If no nominations for the office of President or Vice-President are received, the Board may by a two-thirds majority of the votes cast appoint an interim President and Vice-President for a period of one year. Meeting no more than 18 weeks after the Full Members’ Business Meeting. Subsequent meetings are convened by the Executive Board itself. The Executive Board should convene (in person, by telephone or other means) at least 4 times in each financial year. Executive Board Composition The Executive Board consists of the following voting members: President Vice President Five other elected Full Members 6. The General Meeting also elects up to five other Board members (in addition to the President, Vice-President and Treasurer) for a term of office of one year (1 October of the year in which the election is held to 30 September of the following year). Nominations for the office of President and Vice-President must be circulated to full members at least four weeks before the relevant General Meeting. They should include candidates from European states in which full members are based. The Executive Board consists of the following non-voting members: Immediate past President Treasurer General Manager 7. The General Meeting also elects the Treasurer for a two-year term of office (1 October of the year in which the election is held to 30 September two years later). There is also the option for the Board to recommend the Treasurer be elected by the members for a 4 year term. The Treasurer need not be associated with an active member. The Treasurer may propose an auditor or a bookkeeper to assist him. Voting Executive Board member term: 1 October to 30 September of following year. Board members are eligible for re-election. The nomination must be circulated to full members at least four weeks before the General Meeting. Board Voting 8. With the exception of the Treasurer, all persons elected must be employed by an full member. Office-holders are eligible for re-election, subject to the restrictions set out in no. 5 para. 1 supra, and except for the interim President and VicePresident as per no. 5 para. 2 supra. The Board is quorate if four voting members participate. Other members and individuals may participate in Executive Board discussions at the Executive Board’s discretion/invitation. 9. The General Meeting is entitled to determine the budget and the amount of the membership contribution for the coming fiscal year. The membership contribution is the same for all full members. The amount of the membership contribution for associate members may be different. However, the conditions of Article 4 no. 2 must be respected when the contribution for associate members is set. The Executive Board can pass resolutions, if the Board is quorate, by a simple majority of votes cast. If the Board is not quorate votes may be cast by email or other appropriate means. 8 The budget depends largely on the measures that are necessary for the achievement of the Association’s objective. Annual financial statements must be submitted to the General Meeting for approval. The approval of the annual financial statements also constitutes ratification of the actions of the Board. All voting Executive Board members should excuse themselves from voting if the matter concerns their company or themselves personally. The President has a casting vote in matters unless the matter concerns personally or there is a conflict of interest. 10. The General Meeting may if necessary call on the Board to engage external consultants to help it to resolve specialist problems. In the event that external consultants are engaged to provide support or advice on matters of general interest, the consultancy fee is agreed directly by the Board with the consultants and recorded in the annual budget. All voting Executive Board members must be, and remain, contractually engaged or employed by Full Members. Board Members 11. The General Meeting also decides on the composition, duties, procedures etc. of individual committees, working and national groups. All Executive Board members must participate actively at Executive Board Meetings Any Executive Board member can be removed from office by a unanimous vote of the other voting Executive Board members. Art. 7 The Board 1. It is the responsibility of the Board to manage the Association and to conduct all activities serving to achieve its objectives. It also possesses all authorities that are not reserved to the General Meeting. The Board must take account of resolutions of the full members and of any recommendations made by them. The Board is obliged to notify all members in writing twice a year of developments and progress in the Association’s principal concerns. President May not serve as President for more than four consecutive term years. If the President is unable to fulfil their term, the Vice-President assumes this role. 2. The Board is composed of: a) the current President; b) the previous year’s President; c) the Vice-President; d) five other members elected by the General Meeting; e) the Treasurer and General Manager f) Non-voting Associate members may be appointed to the Board by the voting members on the Board. The number of Associate Members appointed to the Board must not exceed the number of Full member Board members. If there are no nominations for President, or if a President is not elected, the Executive Board will by a two-thirds of the vote cast appoint an interim President for a period of up to one year. The President has to fulfil the duties as outlined in the available job description. If the President is removed from office by a unanimous vote of the other voting Executive Board members then in this situation the Vice President assumes, the responsibilities of the President. If there is no Vice President in office a designated elected Board Member, by a simple majority cast, will assume the responsibilities of the President. The board is quorate if four voting members are present. It passes resolutions by a simple majority of the votes present. 9 3. All voting Board members except the Treasurer and General Manager must be employed by full members. Any full member may propose nominations. Vice President Assume responsibilities of President in their absence. 4. Board members represent the Association vis-à-vis the outside world, an individual member acting jointly with the President or the Vice-President. The President also represents the Association vis-à-vis the outside world. The official seal of the Association may be used by the President for official documents. May not serve as Vice President for more than four consecutive term years. 5. The Board must meet no more than 18 weeks after the Ordinary General Meeting. Subsequent meetings are convened by the Board itself. If there are no nominations for Vice President, or if a Vice President is not elected, the Executive Board may by a two-thirds vote cast appoint an interim Vice President for a period of up to one year. Additional terms are possible if elected by the Full Members. 6. Members of the Board act on an honorary basis. In the event that major projects involve disproportionate time, the full member to which the board member belongs is entitled to claim compensation for time spent. If the Vice President is unable to fulfil their term, the Executive Board can appoint, by simple majority cast, a current Board Full Member to assume this role. 7. Board members and their employers if appropriate are reimbursed in respect of outgoings and expenses. Executive Board Members Up to five Executive Board Full Member individuals (in addition to President and Vice President) are elected for a 1 year term. 8. Allocations of Association resources to committees and working or national groups are agreed twice a year by a simple majority of the Board. 9. All voting Board members must be employed by full members. In the event that any such employment relationship is terminated, the member concerned leaves the Board immediately. The Treasurer and General Manager are not affected by this provision. Elections In the event that a member of the Board leaves office prematurely or is for some other reason unable to exercise it until the end of his term of office, the following provisions apply: Elections for Executive Board positions (including President and Vice President) are conducted as follows: All candidates for the Executive Board must be, and remain, contractually engaged or employed by Full Members. 1. Candidates announced to Full Members. This will be at least 4 weeks in advance of voting. 2. Votes are cast in-person at the Full Members’ Business Meeting or other appropriate means such as email. a) The office of President is assumed by the Vice-President; b) if the Vice-President is not available, one of the remaining Board members is appointed President. c) the functions of any other member are transferred to a remaining member regarded by the Board as being qualified to discharge them. Full members can appoint new members to the Board at any time by the procedure set out in Art. 6 10 nos. 2 and 3. Associate member positions which become vacant are advertised and applications sought. Art. 8 Committees, working groups, national groups Candidates are elected if achieving a simple majority of the votes cast. 1. Committees, working groups and national groups may be formed by the Board at any time, with the prior agreement of the General Meeting, in order to further the aims of the Association. Committees are permanent, while working groups relate to specific tasks and national groups are restricted to particular regions. 2. The chairmen of committees, working groups and national groups are required to attend the General Meeting. 3. When elections are to be held outside of the Full Members’ Business Meeting voting can commence immediately by the appropriate means. If there are five candidates for Executive Board positions they are elected for a one year term if achieving a simple majority of the votes cast. In the case of more than five candidates, then the five nominations for Executive Board that receive the greatest number of votes from Full Members and also have at least a simple majority of the votes cast are elected for a one year term. In the case of a tie the current voting Full Members on the Executive Board make the final decision among the tied candidates. When an Executive Board vacancy arises unexpectedly interim elections for Executive Board members can be held to fill this position. All qualifications, election process and responsibilities apply for interim elected Executive Board members except that the candidate will only be elected to complete the term of the leaving Executive Board member. Treasurer The Full Members on the Executive Board can appoint by a majority vote a non voting Treasurer. The Treasurer is contracted by the Executive Board and the Treasurers’ contract and terms and conditions are reviewed by the President. 11 Art. 9 Amendments to the Statutes / Dissolution 1. Proposals to amend the Statutes or to dissolve the Association must be sent in writing to all full members four weeks before the General Meeting. Such proposals must be made either by the Board or by at least two full members. Resolutions to amend the Statutes or dissolve the Association require a two-thirds majority of full members. Votes may be cast by fax, e-mail and post. 2. Following the dissolution of the Association the Board shall transfer its residual assets to a charitable organisation based in Switzerland (e.g. the International Committee of the Red Cross, Geneva). The distribution of the Association’s assets to members is excluded. Art. 10 Any disputes arising in connection with the present Association shall be referred to the courts at the location of its registered office. 5.Amendments to the Statutes, Disputes and Dissolution 1. Proposals to amend the Statutes or to dissolve the Association must be given in written form to all Full Members four weeks before the Full Members’ Business Meeting or before a vote. Such proposals must be made either by the Executive Board or by at least two Full Members. Resolutions to amend the Statutes or dissolve the Association require a two-thirds majority of Full Members. Votes may be cast by the most appropriate means. Any disputes arising in connection with the present Association shall be referred to the courts at the location of its registered office. 2. Following the dissolution of the Association the Executive Board (by a simple majority vote) shall transfer its residual assets to a charitable organisation based in Switzerland (e.g. the International Committee of the Red Cross, Geneva). The distribution of the Association’s assets to members is excluded. 12