Statutes

Section 1. Name of the Society

1.1. The name of the society shall be society “Association of Biopharmaceutical Drug Manufacturers in Latvia” (hereinafter – the Association) [in Latvian –“Biofarmaceitisko zāļu ražotāju asociācija Latvijā”].

Section 2. Aims of the Association

2.1.1. The aim of the Association shall be to unite Latvian and foreign legal and physical entities performing activity connected with availability of biopharmaceutical medicinal products in Latvia.

2.2. The tasks of the Association shall be:

2.2.1. to establish an organization whose joint activities would unite members of the Association;

2.2.2. to represent interests of its members in relationships with state, municipal institutions, companies, enterprises, other legal and physical entities;

2.2.3. to promote discussion about biopharmaceutical matters between the members of the Association, other organizations in Latvia and abroad, structures representing the government of the Republic of Latvia, and Association in general;

2.2.4. to elaborate and implement in practice legislative initiatives concerning biodiagnostics and biopharmacy, especially for ensuring availability of biopharmaceutical medicinal products in Latvia;

2.2.5. to facilitate elaboration of legal framework related to circulation of biopharmaceutical drugs, facilitating the applicability of the following principles to the biopharmaceutical drugs:

1) extrapolations drug indications and other extrapolations – permissible only if scientifically justified;
2) substitution – cannot be applied automatically and it is the competence of the physician;
3) replacement – considered only when based on the approved Summary of product characteristics and robust clinical data;

4) traceability – is ensured by using the brand name in drug prescriptions and in other documentation (medical documentation, guidelines, etc.)

2.2.5. to promote allocation of financial resources to biopharmacy and biodiagnostics, ensuring their availability to inhabitants of Latvia;

2.2.6. to promote availability of the latest and most efficient innovative biopharmaceutical medicinal products to inhabitants of Latvia;

2.2.7. to publicly express opinion about topical and problematic matters connected with biopharmacy.

2.3. In order to reach the aim and accomplish the tasks of the Association set in the Articles of Association, the Association shall use the following methods:

2.3.1. cooperation with structures representing the government of the Republic of Latvia, elaborating and implementing legislative initiatives concerning movement of biopharmaceutical medicine;

2.3.2. cooperation with legal and physical entities whose activities are connected with biodiagnostics and biopharmacy, especially researches, development, introduction and monitoring of biopharmaceutical medicinal products;

2.3.3. creates data bases using all available technologies and technical possibilities;

2.3.4. participation in local and international activities that aid achievement of the aims of the Association;

2.3.5. establishment of expert groups for solving problems connected with biopharmacy;

2.3.6. informs inhabitants of Latvia about topical events and news in production and research of biodiagnostic and biopharmaceutical medicinal products;

2.3.7. other legally allowed activities connected with achievement of the aims of the Association;

2.3.8. as additional activity, the Association performs economic activity connected with maintenance or use of its property, and performs other economic activity in order to achieve the aims of the Association.

Section 3. Period of activity of the Association

3.1. The Association has been established for an unlimited period.

Section 4. Joining, leaving the Association, exclusion of members of the Association

4.1. Any physical and legal entity with capacity to act or partnership with legal capacity can join the Association by submitting a written application in a particular form. The board of the Association shall determine the form of the application and the list of documents to be annexed to it.

4.2. A decision regarding inclusion of a member in the Association shall be made by the board of the Association. The board shall review the application of the applicant in the nearest meeting, but not later than within 1 (one) month after receiving all the necessary documents. The applicant shall be invited to the meeting where the application of the applicant shall be reviewed, and he or she shall be given the opportunity to express his or her opinion. Failure of the applicant to attend to the meeting shall not be an obstacle for the board to make the decision. The board shall inform the applicant about the motivated decision in written form within one week after making the decision.

4.3. The applicant may appeal a negative decision of the board in written form at the general meeting of the members. If the general meeting of the members also declines the application of the applicant, it shall mean that the applicant has not been admitted as the member of the Society, and he or she may submit a repeated application not sooner than after the period of one year.

4.4. A member may leave the Association at any time, informing the board about it in written form.

4.5. A member may be excluded from the Association with the decision of the board if:

4.5.1. the member has not paid the membership fee for more than 3 months;

4.5.2. the member does not comply with the decisions of the general meeting and of the board;

4.5.3. the member does not fulfill his or her obligations and undertaken liabilities;

4.5.4. the member performs other activity that is in contradiction with what is established by these Articles of Association;

4.6. The board shall review the matter regarding exclusion of a member of the Association at the nearest meeting, inviting the member to be excluded and giving him or her the opportunity to express his or her opinion. Failure of the member to arrive to the meeting shall not be an obstacle for the board to make the decision. The board shall inform the member to be excluded about the decision to exclude the member from the Association and motivation of such decision in written form within five days after making the decision.

Section 5. Rights and duties of the members

5.1. Members of the Association shall have the following rights:

5.1.1. to participate in administration of the Association;

5.1.2. to receive information about activity of the Association, including to get acquainted with minutes, decisions and orders of all institutions of the Association;

5.1.3. to participate in all events organized by the Association, submit propositions about activity of the Association and its improvement, to express his or her opinion.

5.2. Members of the Association shall have the following duties:

5.2.1. to observe the Articles of Association of the Association and comply with the decisions of the meeting of members and of the board;

5.2.2. to pay the membership fee on regular basis, if such is set;

5.2.3. with active participation to support implementation of the aim and tasks of the Association.

5.2.4. after receipt of a respective request from the Board of the Association, the members shall provide their opinion with respect to the Association’s initiatives, activity plans or contents of the communications to third parties within the term determined by the member of the Board/ the Board. If the member’s opinion will not be provided within the above term, it will be considered that the respective member has confirmed the respective proposition, action plan or third party communication of the Association.

5.3. Responsibilities of a member may be established by a decision of the meeting of the members or of the board. When imposing responsibilities upon a member that differ from responsibilities of other members, consent of such member shall be required.

Section 6. Calling of a meeting of the members and making of decisions

6.1. A meeting of the members shall be the highest decision-making body of the Association.

6.2. All members of the Association shall have the rights to participate in the meeting of the members. The members may participate in the meeting of the members in person only.

6.3. An extraordinary meeting of the members may be called a initiative of the board or if requested in written form by at least one tenth of the members of the Association, stating the reason for calling such meeting.

6.4. Meeting of the members shall be called not later than two weeks before the meeting by sending a written notice to each of the members.

6.5. The meeting of the members shall have a quorum if attended by more than one half of the members.

6.6. If the meeting of the members does not have a quorum, a repeated meeting of the members shall be called within three weeks, and it will be deemed to have quorum regardless of the number of members present provided that at least two members participate in it.

6.7. A decision of the meeting of the members shall be adopted if more than one half of the members present vote for it. A decision regarding amendments to the Articles of Association, termination and continuation of activity of the Association shall be adopted if more than two thirds of the members present vote for it.


Section 7. Executive body

7.1. The board consisting of three members of the board shall be the executive body of the Association.

7.2. Members of the board shall elect a chairperson of the board from among themselves, and he or she shall organize work of the board.

7.3. The board shall have the right to decide upon all matters that are not in exclusive area of authority of the meeting of the members.

7.4. Members of the board shall have the right to represent the Association only where two members sign.

Section 8. The auditor

8.1. An auditor elected by the meeting of the members for one year shall perform an audit of financial and economic activity of the Association.

8.2. A member of the board of the Association cannot be the auditor of the Association.

8.3. The auditor shall:

8.3.1. perform auditing of property and financial resources of the Association;

8.3.2. provide an opinion about the budget and annual report of the Association;

8.3.3. assess work of accountancy and record keeping of the Association;

8.3.4. make recommendations about improvement of financial and economic activity of the Association.

8.4. The auditor shall perform audit within the terms established by the meeting of the members, but not less than once a year.

8.5. The meeting of the members shall approve the annual report of the Society only after receiving the Auditor’s opinion.

Section 9. Financial resources of the society

9.1. The financial resources of the Association consist of membership joining fees and membership fees, the payment procedure of which is specified below:

9.1.1. The amount of the membership fee is determined by the Board, and the member pays it to the bank account of the Association within 10 working days from the receipt of the decision of the Board on admission of the member to the Association. The decision on admission of a member to the Association comes into force only after payment of the joining fee;

9.1.2. Once a quarter, the Board of the Association prepares a report on the activities of the Association, which summarizes the expenses of the Association. If the financial resources of the Association are not sufficient to cover the expenses of the Association, the Board, in accordance with the relevant regulations, is entitled to impose an obligation on members to pay the membership fee and its amount. In accordance with the decision of the Board, the members transfer the membership fee determined to the bank account of the Association within the term set by the Board.