14 June 2013 - Comments from The Nordic Cochrane Centre and the International Society of Drug Bulletins
The Clinical Trial Regulation is currently being discussed. As patients, researchers, doctors, scientists and civil society representatives we would like to draw your attention not only to the dangers it encompasses but also to the opportunities it brings along.
The International Society of Drug Bulletins issued a statement today to the members of European Parlament to request:
The protection of human subjects must be upheld & citizens’ right to information must be strengthened
The purpose of the Society shall be:
a. to encourage and further the development of independent drug bulletins;
b. to promote international exchange of good-quality information concerning drugs and therapeutics;
c. to engage in whatever ancillary activities the Committee considers desirable for the furtherance of these primary purposes.
"the Society": The International Society of Drug Bulletins
"the Member ": a drug bulletin fulfilling the membership criteria of ISDB. A member bulletin will be represented by its Editor-in-chief or by another designated person from its editorial team.
"the Committee": The governing body of the Society constituted as hereinafter described.
"OGM": Ordinary General Meeting of members.
"EGM": Extraordinary General Meeting of members.
"Drug bulletin": A periodical concerned with the promotion of rational drug therapy and published at least four times a year.
"Good-quality information": Information which fulfils the following two criteria:
a. It is scientifically valid and clarifies current scientific consensus and distinguishes what is established from, what is not;
b. It helps the user of the information to optimise his or her therapeutic activity in the best interests of the patient.
"Independent": A bulletin is independent if it fulfils the following three criteria:
a. it is run by an independent editorial team;
b. its organisational structure and financial resources are capable of guaranteeing the editorial team’s independence.
c. it does not accept any funding from the pharmaceutical industry or related healthcare industry.
The Society's official language is English. The English version of the Articles and Rules of the Society is definitive.
a. Applications for admission shall be submitted in writing to the Committee.
b. The Committee shall examine applications for admission, check that the applicant members fulfil the requirements and give the undertakings specified in Article 5.1.1.
c. In assessing the quality of the content of the bulletins, the Committee may, as and when it considers appropriate, consult other competent people.
d. The Committee shall decide to grant or refuse membership.
e. The applicant member shall be informed of the decision to grant or refuse it membership within one month of the decision being taken.
f. The Committee shall report in detail on successful and unsuccessful applications for membership, and of any resignations of or removals from membership, at each OGM.
g. If the Committee is not able to reach a two-thirds majority in favour either of granting or refusing membership, or if the Committee refuses membership and the applicant so requests, the Committee shall put the matter before the next OGM, which shall have the final say in all disputes relating to admission to membership.
a.The right of using the ISDB logo. Associate members cannot use the ISDB logo.
b.To receive the ISDB Newsletter.
c.To use the ISDB communication network.
d.To have the access to the full website.
a.The membership of each member of the Society shall be regularly reviewed by the Committee, at least once every six years, and the Committee shall in particular check whether the member continues to fulfil all the requirements and undertakings specified in Article 4.1.1
b.The Committee may decide to remove a member from the Society but not unless a recorded-delivery letter has first been sent to the bulletin in question at its address last notified to the Society giving reasons for exclusion and it has been given a reasonable opportunity to furnish its explanation. The bulletin shall be notified within one month of the decision being taken. A bulletin so removed from membership shall have a right to appeal to the next OGM. If this is not to be held within the next six months, it shall have the right to insist that an EGM be held as soon as is reasonably practicable and to appeal to that EGM. On such an appeal, the General Meeting may restore the bulletin to membership if it thinks fit.
4.3.2 A member may resign from membership of the Society with immediate effect by giving formal written notice to the Committee, but shall be liable to pay the membership subscription for the full calendar year during which the resignation takes effect.
4.3.3 If a bulletin ceases for any reason to be a member of the Society it shall cease to be entitled to hold itself out as connected in any way with the Society.
Institutions or individuals sympathetic to the purposes of the Society, but not qualified to be members, may, at the absolute discretion of the Committee and on payment of the relevant subscription, be given the status of Associate Member of the Society.
Associate Members shall have all the rights and obligations of members except those of voting and of standing for office and use of the Society’s logo. Where appropriate, the term "member" in these Articles shall include an Associate Member.
The General Secretary shall be responsible for membership files, correspondence, archives, invitations to meetings, the writing up of minutes and the keeping of records required by law. Membership files should be accessible to the Committee members.
a.The Committee elected by a secret ballot at an OGM shall administer the Society until the end of the next OGM or until otherwise removed by the members.(see 5.2f.)
b. At each OGM members elect the Committee according to the procedure specified below.
a. The Committee shall comprise a maximum of eleven members and a minimum of five members elected by members at the OGM. Each Committee member must be a representative of a member bulletin.
b. At every OGM all the Committee members shall retire from office and shall be eligible for re-election.
c. No person shall be appointed or reappointed to the Committee unless he/she:
(i) is recommended by the Committee; or<
(ii) is willing to be appointed and has been nominated by at least two members of the Society.
d. An OGM or the Committee may, by a simple majority, appoint a person who is willing to act to be a Committee member either to fill a vacancy or as an additional Committee member (provided that the maximum of eleven is not exceeded). It is desirable to have representation of the different regions. Not more than one representative from a member bulletin may be a member of the Committee. The Committee may not co-opt someone to sit on the Committee from a bulletin already represented in the Committee.
e. The members of the Committee are responsible for the running, development and representation of the Society, and for monitoring the quality and independence of member bulletins.
f. The status of Committee member shall lapse on resignation, death or on removal from office by a decision of two-thirds of those present and voting at a General Meeting after the member in question has first been summoned by recorded-delivery letter to appear before the meeting in order to furnish explanations for the actions or omissions described to him therein and has been given a reasonable opportunity to appear and furnish and furnish explanations.
It would also lapse if the bulletin represented by the Committee member was no longer a member of the Society.
g. A person may serve as Chair for a maximum of two consecutive terms.
a. The Committee shall meet upon its election to designate from amongst its members a Chairperson, a Treasurer, a General Secretary, and up to six members having responsibility for the regional development of the Society. Such designation shall be effected by consensus or, if at least two members of the Committee request this procedure, by successive secret ballot majority votes, one such ballot for each post taken in the order in which the posts are listed above, those who have already been appointed to posts being excluded as candidates for other posts.
b. The Committee shall meet in plenary session at least once a year. Committee members may participate by teleconference or videoconference if they are unable to attend in person.
c. The Committee may, from time to time, delegate any of its functions to a sub-committee consisting of one or more persons whether Committee members or not and may revoke any such delegation at any time. Any such sub-committee shall report regularly to the Committee on its activities and decisions. A subcommittee consisting of two or more members shall adopt the same procedure as that specified for the Committee itself so far as it is applicable.
d. The preparation of the ISDB Newsletter and the maintenance and development of the website shall be the responsibility of the Committee.
a. The Committee shall be quorate if at least half of its members participate or are present or represented by a proxy.
b. Each member of the Committee shall have one vote. In the event of a tie the Chairperson of the meeting shall have a second or casting vote.
c. Decisions shall be taken by a majority vote of those present or represented. Decisions concerning admission to or exclusion from membership shall require at least a two-thirds majority of the votes in favour.
d. The minutes shall be recorded and published in the Newsletter. The records shall be kept by the Secretary of the Society and shall be open to inspection by representatives of members of the Society at reasonable times and at reasonable notice.
e. The Committee shall after every meeting inform members in such manner and in such detail as it shall consider appropriate of its deliberations, decisions, actions and discussions.
f. The Committee shall organise a postal or electronic consultation of Members of the Society on matters when requested in writing by at least thirty per cent of members and shall in good faith take account of the results of such consultation but shall not be bound thereby.
a. The Committee Chairperson shall convene General Meetings and the Committee meetings.
b. The Chairperson shall be fully authorised on behalf of the Society to execute all deeds and sign all documents necessary or expedient to implement decisions of the Committee or General Meeting and to represent the Society in all official acts. He or she shall have legal capacity to go to law as defendant or as plaintiff or to lodge appeals on behalf of the Society, in all cases by leave of the Committee. He or she may only agree to amicable settlements with the approval of the Committee.
c. He or she shall chair all meetings and, if prevented from so doing, shall designate a member of the Committee. If the Chairperson is unable to attend and has not appointed a designate, the Committee members present shall elect one of their number to be Chairperson of the meeting.
a. The Treasurer shall be responsible for managing the funds of the Society and, under the supervision of the Committee Chairperson, shall settle all accounts, receive all subscriptions due to the Society and give receipts for the same; he/she may not part with cash, property or valuables belonging to the Society without the consent of the Committee. He/she is empowered to make payments to the value of 5000 pounds sterling. In the case that higher sums are in question the Chairperson should co-sign the authorisation.
b. He/she shall keep accurate accounts covering all transactions carried out by him/her and shall present the accounts and report on hi/her management at the OGM.
a. An OGM shall be convened at least once every three years.
b. It shall consider motions to approve the accounts for the previous financial periods since the last OGM and the budget forecast for the period until the next OGM.
c. Any General Meeting that is not an OGM shall be called an Extraordinary General Meeting (EGM).
d. At least three months written notice of each General Meeting shall be given or posted to each member at its address last notified to the Society. Accidental non-receipt by a member of notice of a General Meeting shall not invalidate any of the business conducted thereat. A General Meeting may be held at shorter notice if it is so agreed, in the case of an OGM, by all the members and, in the case of an EGM, by at least three-quarters of the members .
e. Any member may propose an item for the agenda of any General Meeting but the agenda shall be drawn up by the Committee.
f. In addition to the items put on the agenda by the Committee any motion signed by two members and lodged with the General Secretary at least one month before the meeting shall be put before the meeting.
g. In order to be able to deliberate, a General Meeting shall require a quorum of one-third of the total membership either present or represented. if this quorum is not reached, the Committee must in the following two months organise postal voting by all Members on questions regarded as essential by the Members present or represented at the inquorate meeting.
h. Motions put before a General Meeting shall be decided on a simple majority of votes cast at the meeting unless these Articles or the Rules otherwise specify.
i. Voting to appoint members of the Committee shall be by secret ballot. Votes on other matters shall as a general rule be by show of hands, but if at least two Members, either present or represented, request it, any vote may be taken by secret ballot.
l. Resolutions to change the Articles of the Society and to dissolve the Society shall require at least a three-quarters majority vote of an OGM or EGM; resolutions to change the Rules of the Society shall require at least a two-thirds majority vote of an OGM or EGM. Votingshall be taken by secret ballot. Two persons elected in advance and not standing for election themselves, will be responsible for the election. They will count the votes. Ballots will be preserved by the Secretary.
m.The Chairperson shall convene an EGM if a written request that one be held is signed on behalf of half the members and lodged with the Secretary.
7.1 In the event of dissolution of the Society, the General Meeting shall decide what shall be done with the Society's assets but shall not be empowered to allocate to Members of the Society more than the amounts of their contributions.
7.2 It shall designate public bodies, charities or other private bodies officially recognised as devoted entirely to the public interest or as associations having objects similar to those of the Society, as recipients of any remaining assets after payment of all debts, charges and liquidation expenses relating to the Society.
7.3 The General Meeting shall appoint one or more liquidators who shall be independent qualified accountants, to carry out the liquidation process and shall decide on the manner of such liquidation.
Each member shall pay an annual subscription. The annual rate shall be set at each OGM or at any EGM if the EGM so decides. A member joining part way through a year shall pay an apportioned part of that year’s subscription. No subscription or apportioned part of a subscription shall be refunded if a member ceases for any reason to be such during the year to which it relates..
a. subscriptions from Members;
b. any subsidies or donations granted or made to the Society by individuals or institutions, professional or amateur, with the exception of subsidies from the pharmaceutical industry or comparable industry and related healthcare industry;
c. income derived from services provided by the Society;
d. capital arising from surpluses on the annual budget.
A set of Rules governing the implementation of the Articles hereof may from time to time be voted by members at the OGM on a motion put before it by the Committee.
The said rules shall be appended hereto and shall apply to members in the same manner as the Articles hereof.
Subscription (supplement to article 8 of the society's articles)
The subscription shall be fixed according to Article 8 of the Constitution. It shall be paid no later than 3 months after receipt of the subscription invoice sent to each member bulletin each year by the Committee.
Constitution of member status(supplement to article 4 of the society's articles)
II.1 An application for admission must comprise:
(a) two copies of each of the last five consecutive issues of the bulletin preceding the date of application. If the issues do not specify the contents in English then a list of these contents, including keywords, shall be sent with the issues;
(b) a completed application form; and
(c) the admission fee (which will be refunded if the application is not accepted).The Committee may request further information to assist it in making its decision.
II.2 As each issue is published, member bulletins shall send two copies of it to the Secretary of the Society or to the Institution charged to keep the library of ISDB.
II.3 List of Members of the Society
Before each OGM or EGM the Committee will draw up an official list of Members of the Society.
Communication tools: the ISDB newsletter and website
An official publication (Newsletter) of ISDB, issued at least 3 times a year, and a Website are the responsibility of the Committee of the Society. The Committee will serve as editorial board of both. The Newsletter will report events important for the Society, news from the various member bulletins, interesting articles, activities of ISDB, reports of the Committee etc. Both the Newsletter and the Website will serve as a way of communication between the members and the Committee as well as a way of transmitting important events which happened in and outside ISDB. The Website also has the purpose of presenting ISDB outside the Society. The contents of the Website should be updated monthly.
Bulletins written for patients and bulletins published electronically
Bulletins aimed at patients or published electronically can become member bulletins provided they meet the criteria for membership.
Includes revisions agreed at the ISDB General Assembly
Melbourne, September 2005