TRPMA Article

Chapter 1: General Rules 

Article 1   The official name of the Association is “Taiwan Research-based Biopharmaceutical Manufacturers Association” (hereafter the Association).

Article 2   The Association is a legally established non-profit civil organization with the purposes of promoting the research and development of new biopharmaceuticals, improving research standards and enhancing human health. 

Article 3   The Association is a nationwide organization, operating in the administrative regions of the R.O.C. 

Article 4   The Association’s office shall be located in the same city as the office of the competent authority.  Branch offices may be set up with the competent authority’s approval.  The regulations and organization of branch offices are formulated by the Board of Directors, and implemented with the competent authority’s approval.  The registration and changes of the addresses of the Association and its branch offices shall be reported to the competent authority.  

Article 5   The Association’s activities include:

1. To handle issues concerning the research, development and manufacture of new biopharmaceuticals;

2. To establish and promote the regulations and standards concerning new biopharmaceuticals;

3. To handle bio-pharmaceutical related issues, such as information exchange, technical cooperation, funding, training and education, etc.;

4. To support the government’s policies, regulations and campaign activities for new drug R&D and manufacture;

5. To organize conferences, seminars, discussion groups and special projects in relation to the development of new biopharmaceuticals and the improvement of manufacturing standards;

6. To facilitate cross-strait and international cooperation projects which serve the purposes of the Association;

7. To engage in activities which serve the purposes of the Association.

Article 6   The Ministry of Interior is the competent authority governing the Association.  The Department of Health is the industry competent authority.  The industry shall be under the guidance and supervision of the industry competent authority.

 

Chapter 2: Membership 

Article 7   The Association provides two types of membership:

1. Corporate Membership: Companies in Taiwan engaging in the R&D or manufacture of new biopharmaceuticals can receive the corporate membership if their applications are approved by the Board of Directors.  Each corporate member shall appoint representatives to exercise their rights.  The number of representatives for each corporate member is determined by the annual fee schedule.  Members paying Grade 1 fees can have one representative each; and members paying Grade 2 fees can have three representatives each. 

2. Honorary Membership: Those who have special contributions to the development of new biopharmaceuticals or to the Association may be nominated by the Association’s member for the honorary membership.  The membership will be granted upon the approval of the Board of Directors.  

Article 8   In case of violation of the law, the Articles of the Association or the resolutions adopted by the General Assembly or by the Managers Meeting, the Board of Directors may suspend the rights of the members (representatives) involved.  Members involved in serious violations may be expelled at the discretion of the General Assembly. 

Article 9   Members may terminate their membership by issuing a written notice to the Association stating the reasons of the termination. The membership ceases to be effective from the end of that fiscal year. 

1. Any prospective membership applicant should submit a completed application form to the Association.  The Board of Directors shall decide whether to accept or reject the application according to the decision agreed by over one half of the attendance.

2. The Board of Directors shall create and retain the “Association Register”, which should include the following information:

(1) The names and addresses of members;

(2) The names of representatives who are authorized to attend meetings and cast votes on behalf of members. 

Article 10   Members may terminate their membership by issuing a written notice to the Association stating the reasons and effective date. 

Article 11   No refund will be given to members who have terminated their membership or been expelled from the Association.    

Article 12   Corporate members have the right to vote, to elect, to be elected and to recall.   Each representative has exactly one vote.  Honorary members are not entitled to the aforementioned rights.

Article 13   Members shall abide by the Articles of the Association and resolutions of the Association, and have the obligation to pay annual fees.

 

Chapter 3: Organization and Staffing

Article 14   The General Assembly is the highest power body of the Association.  If the total number of members (representatives) exceeds 300, regional representatives may be elected to exercise member’s rights in the General Assembly based on the principle of proportional representation.  The term of representation is two years.  The number of representatives and relevant regulations shall be established by the Board of Directors and be put into practice after reporting to the competent authority. 

Article 15   The functions of the General Assembly are:

1. To establish and amend the Articles of the Association;

2. To elect or recall Directors and Supervisors;

3. To determine the amount of membership registration fee, annual fee, service charge and member donation, as well as payment methods;

4. To review the annual operation plan and progress reports, and to make and balance the budget;

5. To decide on the expulsion of a member or representative;

6. To decide on the disposal of property;

7. To decide on the dissolution of the Association;

8. To resolve important issues concerning the rights and obligations of members.

The scope of important issues said in Item 8 is determined by the Board of Directors.

Article 16   The Association shall install nine Directors and three Supervisors, all elected by members.  The Association shall establish the Board of Directors and the Board of Supervisors.  In the election of Directors and Supervisors, three Alternate Directors and one Alternate Supervisor shall also be elected to sequentially fill in vacancies left by regular Directors or Supervisors until the end of a service term.  The position in election rankings is determined by the number of votes.  In situation where there is a tie, the ranking shall be determined by drawing lots. 

The current Board of Directors may recommend a list of candidates for Directors and Supervisors of next term.  Though postal election is a viable method for electing Directors and Supervisors, this method shall not be used successively.  The regulations of postal election is established by the Board of Directors and implemented after reporting to the competent authority.

Article 17   The functions of the Board of Directors are:

1. To determine issues of holding the General Assembly, and to represent the Association according to the Articles of the Association and the resolutions adopted by the General Assembly;

2. To examine and approve member’s qualifications;

3. To elect or recall Standing Directors and President, and to submit the proposal of recalling Directors to the General Assembly;

4. To decide on the resignation of Directors, Standing Directors and President;

5. To hire and dismiss employees;

6. To draw up annual operation plan and progress reports, and to make and balance budget;

7. To carry out other duties as required.

Article 18   The Board of Directors shall elect among themselves three Standing Directors, and elect one President and one Vice President among the Standing Directors.  The service term is two years. The President shall be in charge of internal affairs of the Association, represent the Association and preside at the General Assembly Meetings and Board Meetings.  The President should supervise the Association’s operation and attend meetings as required.  In situations where the President is not able to perform his/her duties, the Vice President shall act on behalf of the President.  In the absence of such designation, one of the Standing Directors shall be elected to be in charge.  Vacancies of the President or Standing Directors shall be filled within one month through by-election.

Article 19   The functions of the Board of Supervisors are:

1. To supervise the work of the Board of Directors;

2. To audit the year-end financial reports and submit them to the General Assembly for approval;

3. To elect or recall Standing Supervisors;

4. To decide on the resignation of Supervisors and Standing Supervisors;

5. To carry out other duties as required.

Article 20   The Board of Supervisors shall elect among themselves one Standing Supervisor to supervise daily affairs and preside at the Board of Supervisors Meetings.  In situations where the Standing Supervisor is not able to perform his/her duties, one Supervisor should be appointed as his/her delegate.  The vacancy of the Standing Supervisor should be filled within one month through by-election.  In the absence of such designation, Supervisors should elect among themselves one delegate. 

Article 21   A Supervisor shall not concurrently hold the position of Director, and vice versa.

Article 22   Directors and Supervisors are unpaid positions; and the service term is two years.  Both positions are eligible for re-election. The President can only have one re-election.  The service term of Directors and Supervisors shall commence from the date of the first Board of Directors Meeting.

Article 23   Directors or Supervisors involved in any of the following situations shall be dismissed from the position immediately:

1. The qualification for a member or representative is no longer valid.

2. A resignation has been accepted by the Board of Directors or the Board of Supervisors.

3. A decision of recall or dismissal has been made.

4. Member’s right has been suspended for more than one half of the service term. 

Article 24   The Association shall have one Secretary General to be in charge of the Association’s affairs under the direction of the President.  The employment and dismissal of other staff of the Association shall be proposed by the President and approved by the Board of Directors, as well as reported to the competent authority for future inspection. Directors and Supervisors shall not take up any of the aforementioned posts of the Association.  The staff’s responsibilities and duties are determined by the Board of Directors.

Article 25   The Association may form various committees, taskforces or internal groups.  The establishment and amendment of the protocol thereof shall be approved by the Board of Directors. 

Article 26   The Association may appoint one Honorary President, up to nine Honorary Directors and up to three Honorary Advisors.  All posts are on an unpaid basis. The service term is the same as that of the Directors and Supervisors.  The aforementioned honorary positions are not members of the Association.  Therefore, they neither have the right to vote or any other member’s rights, nor need to fulfill member’s obligation (such as paying annual fees).

 

Chapter 4: Meetings

Article 27   There are two types of General Assembly Meeting: regular meetings and extraordinary meetings.  Both types of meetings are convened by the President.  A written notice shall be issued to every member at least fifteen days in advance.  However, in case of emergency, the notice of an extraordinary meeting can be issued just one day in advance.  Regular meetings shall be organized once every year.  Extraordinary meetings can be called whenever the Board of Directors deems necessary, or upon the request of over one-fifth of the members or upon a written request issued by the Board of Supervisors.  The meeting notice should specify the type of the meeting, time, place and agenda.  After the Association obtains the legal person status, the threshold for holding an extraordinary meeting shall be one-tenth of the members (member representatives).  

Article 28   In situations where a member is not able to attend the General Assembly Meeting, he/she may appoint another member as proxy by issuing a written statement.  Each member is allowed to act as proxy for exactly one other member. 

Article 29   The resolutions adopted by the General Assembly Meeting shall be approved by the majority of the members attending the meeting, whose number shall exceed the threshold of one half of the members.  Decisions on the following issues can be made if they are agreed by over two-third of the attendance:

1. To establish or amend the Articles of the Association;

2. To dismiss a member;

3. To recall a Director or a Supervisor;

4. To dispose the property;

5. To dissolve the Association;

6. To determine important issues concerning member’s rights and obligation.

After the Association obtains the legal person status, the amendment of the Articles of the Association shall be approved by over three quarters of the attendance or be consented in writing by over two-third of the members.  The decision of dissolving the Association can be made at any time with the consent from over two-third of the members. 

Article 30   The Board of Directors shall call a meeting once every six months, so does the Board of Supervisors.  Extraordinary meetings can be organized whenever deemed necessary.  The notice of an extraordinary meeting can be issued one day in advance; otherwise, a seven-day meeting notice should be sent to every member and report to the competent authority.  The resolutions adopted by the Board Meeting shall be approved by the majority of the Directors or Supervisors attending the meeting; and the attendance should exceed the threshold of one half of the number of Directors or Supervisors.  The aforementioned meeting notice shall specify the type of meeting, time, place and agenda. 

Article 31   Directors and Supervisors shall attend the Board Meetings in person.  Proxy is not allowed.  Two consecutive absences without explanation will be treated as resignation. The vacancy shall be filled by Alternate Directors or Alternate Supervisors.

 

Chapter 5: Funding and Accounting

Article 32   The Association’s funding sources are:

1. Membership registration fee: Each corporate member shall pay NT$100,000 at the entry of the Association.

2. Annual fee for corporate members: Grade 1: The annual fee is NT$300,000 for companies whose products are still under development or whose sales volume is under NT$500,000,000.  Grade 2: The annual fee is NT$1,000,000 for companies whose products are already on the market and whose sales volume is over NT$500,000,000 (inclusive).

3. Business revenue;

4. Member’s donation;

5. Revenues from service rendered;

6. Fund and interests;

7. Other revenues.

Article 33   The Association’s fiscal year is based on the calendar year, beginning on January 1 and ending on December 31.

Article 34   Two months prior to the beginning of a fiscal year, the Board of Directors shall have next year’s annual operation plan, budget sheet and employees’ payroll ready to be submitted to the General Assembly for approval (In situations where the General Assembly is not held as scheduled, the documents shall be submitted to the Joint Board of Directors and Supervisors for approval.)  The documents shall be submitted to the competent authority before the beginning of a new fiscal year.  Within two months following the end of a fiscal year, the Board of Directors shall prepare an annual operation report, an income and expenditure statement, a cash flow statement, a balance sheet, a property inventory list and a fund statement and submit the documents to the Board of Supervisors for review.  The Board of Supervisors shall return the comments to the Board of Directors.  The documents shall be presented to the General Assembly for adoption and then be submitted to the competent authority for future inspection (In case the General Assembly is not held as scheduled, the documents shall be submitted to the competent authority first.)

Article 35   After the dissolution of the Association, the surplus property of the Association should be distributed to a local self-governed organization or any organization specified by the competent authority.

 

Chapter 6: Supplementary Articles

Article 36   Omissions of the Articles of the Association are subject to relevant laws and regulations.

Article 37   Implementation details shall be established by the Board of Directors.

Article 38   The Articles of the Association become effective after being adopted by the General Assembly and reported to the competent authority.  The same requirements apply to the amendment of the Articles. 

Article 39   The Articles of the Association were adopted in the first meeting of the first term General Assembly held on November 28, 2012, and were reported to the Ministry of Interior on December 24, 2012 (Ref. No. 1010399736). 
The amendment of Article 32 was passed in the second meeting of the first term General Assembly held on July 10, 2014, and was reported to the Ministry of Interior on September 10, 2014 (Ref. No. 1030303426).