Appendix 1: Procedure for Review of Complaints and Disputes

1. PROCEDURE FOR REVIEW OF COMPLAINTS AND DISPUTES REGARDING VIOLATIONS OF THE AIPM CODE OF PRACTICE


1.1. The AIPM will only review complaints regarding violations of the Code («Complaints») with regard to activities of companies within the Russian Federation and/or targeted at a Russian audience.


1.2. A complaint about a violation of the Code can be filed by both an AIPM member and any other interested person.


1.3. The complaint may be filed either against an AIPM member or any pharmaceutical manufacturer who is not a member of the AIPM but carries out its activity in the Russian market.


1.4. The procedure for filing a Complaint in respect of violations of the Code depends on the parties to the dispute.


2. PROCEDURE FOR REVIEW OF COMPLAINTS AND DISPUTES BETWEEN COMPANIES THAT ARE AIPM MEMBERS


2.1. Before filing to the AIPM a Complaint in respect of violations of the Code AIPM members are under the obligation to try to settle their dispute themselves. At the same time, the applicant company may notify the AIPM Executive Director (the «Executive Director») about sending the corresponding Complaint accordingly.


2.2. Upon receiving a Complaint, an AIPM member company is to provide a response within ten business days. These terms start as from the moment the Complaint is received by that company.


2.3. If the complaining company fails to receive a response within the above period or the foregoing procedure fails to result in a resolution satisfactory to both parties in dispute, the complaining company may file an application addressed to the AIPM Executive Director for a special panel (the «Special Panel») to be formed in order to review and resolve the case. 


3. PROCEDURE FOR THE REVIEW OF COMPLAINTS FILED WITH THE AIPM


3.1. Subject to compliance with the requirements of clause 1 of this Procedure, AIPM members and other interested parties may file a Complaint in respect of the activities of any pharmaceutical manufacturer, including, but not limited to, those that are not AIPM members, but carry out their activities in the Russian market.


3.2. A Complaint should be filed by the head of the company (general director, head of a representative office, branch, etc.) or by person authorized by him (by a power of attorney) in writing and addressed to the AIPM Executive Director.


3.3. Complaints are sent by the company to the location of the AIPM Secretariat or to the email address of the AIPM Secretariat.


3.4. A Complaint should contain:

  • the identity of the company that is alleged to have committed a violation of the Code;
  • the name(s) of the pharmaceutical product(s) in regard to which there are suspicions of a violation of the Code;
  • documents and materials evidencing the alleged violation, for example, advertising materials, in a format and quality that allows to familiarize with them;
  • the date of the alleged violation;
  • a brief description of the essence of the alleged violation, including references to the corresponding points of the Code;
  • documents and materials indicating the efforts of the parties to independently resolve the dispute between themselves, undertaken before applying to the AIPM.


3.5. The materials relating to the complaint (files) are confidential. Only the parties to the dispute have access to the materials of the case. The only exception will be if a Special Panel is formed to review the case.


3.6. The parties to the dispute, the Executive Director and the Secretariat of the AIPM, and the members of the Special Panel should observe the confidentiality of the materials of the case.


3.7. The disclosure of the case materials to a third person shall be considered a serious violation of AIPM procedures.


3.8. Upon receiving the Complaint, the Executive Director ascertains the presence of the necessary documents and materials, prepared in accordance with clause 3.4. of Appendix 1, as well as indications of violation of the Code. Having verified the compliance with the mandatory requirements, and within 4 business days of having received the Complaint, the Executive Director confirms to the complainant that the Complaint has been accepted for review, and informs the company with regard to which the Complaint was accepted and provides it with the Complaint as well as the documents and materials received.


3.9. At the written request of the complainant, its identity can be withheld from the company with regard to which the Complaint is made. In such a case, it shall be the responsibility of the complainant (and not the responsibility of AIPM or the Executive Director) to ensure that the documents and materials submitted in support of the Complaint do not identify the complainant.


3.10. Any period of time mentioned in this Procedure starts on the day following the calendar date or the occurrence date that defines the beginning of the period. If the period is set for performing an act, the latter may be performed by twelve p.m. of the last day of the period. However, if the act is to be performed at an organization, the period expires when, under the established rules, the relevant operations at that organization are stopped. Written complaints and notices delivered to a communication organization by twelve p.m. of the last day of the period are deemed timely.


3.11. The company with regard to which the Complaint was filed should provide a response within ten business days. This term starts as from the moment the Complaint is received by that company. Upon having a valid excuse, the company in the same period may request that the period established for its response be extended (but by no more than 15 business days) by filing an appropriate request which should provide the reason for the requested extension. The response should be in writing and addressed to the Executive Director. The response is sent by the company to the location of the AIPM Secretariat or to the email address of the AIPM Secretariat.


3.12. The response should contain:

  • a recognition of the fact of a violation of the Code and information about steps taken to correct the situation;



or

  • a refusal to recognize a violation of the Code, as well as clearly formulated and, in appropriate cases, grounds for such a refusal with supporting documentation.



Upon receiving a response, the Executive Director must within 2 business days forward it to the complainant. The complainant must review this response and respond to the Executive Director within 5 business days as to whether or not the response is satisfactory. Thereafter, the Executive Director decides whether the dispute has been resolved, or whether the AIPM must take additional actions to facilitate the resolution of the dispute.


3.13. In order to achieve a solution satisfactory to the parties, after receiving the Complaint the Executive Director may invite the applicant and the company in respect of which the Complaint was submitted to hold a joint meeting to independently resolve the dispute between the parties through the mediation of the AIPM. Based on the results of the meeting, the Executive Director sends the minutes of the meeting to the parties within four working days.


3.14. If the response is satisfactory to the complainant, and the resolution does not harm the interests of any other AIPM member or further violate the Code, then this fact is recorded by the Executive Director, and the case is closed. The case may also be closed if the Executive Director deems the response to be satisfactory and the complainant has not reacted to the response within the required 5 days.


3.15. Thereafter, it is the obligation of both sides in the Complaint to ensure that any agreements and/ or undertakings embodied in their agreed resolution of the Complaint are adhered to. If such agreements and/or undertakings are not adhered to, either party may make a new claim to the Executive Director, which would follow the same process as described above.


3.16. If the above-mentioned procedure has not resulted in a decision satisfying the disputing parties, the Executive Director shall form a Special Panel for reviewing and taking a decision on the case. A Special Panel can be formed when the company with regard to which a complaint was received did not respond to it within the established term.


3.17. A Special Panel is formed to review a concrete case and the 5 members of this Special Panel are chosen from the 20 members of the Standing Dispute Resolution Panel (the «Standing Panel»). 


4. STANDING PANEL


4.1. 20 members of the Standing Panel shall be chosen by a General Meeting of the AIPM from (i) the senior employees of AIPM members who preferably work in the medical, legal, ethical and regulatory departments of such member companies and (ii) other stakeholders. General Managers (Heads of Representation), sales, and marketing managers are not eligible to be members of the Standing Panel. The Executive Director is an ex officio member of this Standing Panel.


4.2. Members of the Standing Panel will be chosen for two year ‘staggered’ terms, such that each year ten members of this Standing Panel will be chosen annually at a General Meeting of the AIPM.


4.3. If a Standing Panel member ceases to be employed by an AIPM member company, or if that company ceases to be a member of the AIPM, such Standing Panel member shall immediately be ineligible to remain on the Standing Panel. A replacement will be selected at the next General Meeting of the AIPM to fulfill the remainder of the term of the departed Standing Panel member.


5. SPECIAL PANEL


5.1. When it is understood that a Special Panel should be formed in order to resolve a dispute, this Special Panel is formed by the Executive Director within ten business days (for instance, after the end of the period for a reply, or after receipt by the claimant of the respondent’s negative reply). In order to do so, and after consultation with the disputing parties, the Executive Director determines if any members of the Standing Panel have a conflict of interest with any of the disputing parties. If any are found to have such conflicts of interest, they are deemed ineligible to participate in the Special Panel for that specific case. Examples of a conflict of interest would include members who have products in competition with the products of the parties involved in the dispute.


5.2. The parties are to agree upon the candidates to serve on the Special Panel within three business days of receiving a notice of the nominations. Should there be a conflict of interest between any member of the Special Panel and either of the parties, either party to the dispute may challenge the relevant candidates, but on no more than twice.


5.3. An independent expert may be invited to serve on the Special Panel as a legal consultant. The invited legal consultant may be rejected by either of the disputing parties. In such a case, the Executive Director shall propose another legal consultant. If the necessary legal consultant is not agreed upon within three business days, the Special Panel shall carry out its activity without a legal consultant.


5.4. If either party fails to provide a response regarding the composition of the Special Panel by the expiry of three business days, the Executive Director may deem the membership of the Special Panel to have been agreed upon.


5.5. The Executive Director presides over meetings of the Special Panel. Neither the Executive Director nor the legal consultant has the right to vote during decision-making. The AIPM secretariat provides technical support for the Special Panel’s work.


5.6. To preserve the utmost confidentiality and ensure the most objective results possible, the meetings of Special Panels will be closed, and their deliberations will be kept strictly confidential. During these deliberations the disputing parties will not be present.


5.7. Special Panel members familiarize themselves with all materials concerning the case under examination and make a decision as to whether a violation of the Code took place. In order to ensure a comprehensive consideration of the dispute, the Special Panel may assess whether these materials are in line with other provisions of the Code, that have not been specified in the Complaint. The decision is made in the form of recognition or non-recognition of a violation. Also possible is the making of recommendations regarding the elimination of negative consequences of the violation that took place. Before being pronounced, the written decision is studied by an AIPM legal consultant, if any has been accepted.


5.8. If a Special Panel member cannot attend a Special Panel meeting for a good reason, he/she can study the materials subject to all the established requirements for reviewing the case and take a decision on another day, but not later than seven business days from the time the main Special Panel meeting is held. If a member of the Special Panel misses its meetings dealing with the same case on a regular basis (on three or more occasions), that person is excluded from the Special Panel.


5.9. If a Special Panel decides that it is impossible to review the case without requesting additional materials from the Parties, the Executive Director shall send the relevant request within two business days. The Parties should provide additional materials within five business days from the receipt of the request. Next, the Executive Director shall schedule a second meeting of the Special Panel within ten business days. The Parties are informed of the Special Panel’s decision as usual.


5.10. The decision of the Special Panel will be communicated in writing to the disputing parties by the Executive Director within two business days of such decision.


6. APPEAL PROCEDURE


6.1. If one of the disputing parties disagrees with the decision, it may make an appeal in writing to the Executive Director within ten business days of being advised of the decision. 


6.2. The Executive Director will then convene the Special Panel that rendered the decision within ten business days of receiving this request for an appeal. The disputing parties may choose to attend this meeting of the Special Panel in order to argue their respective cases in person. During the deliberations of the Special Panel on this appeal the Executive Director and the legal consultant, if one has been agreed, will now have one vote each. If the Special Panel reached a decision on the basis of even numbers (due to the absence of the legal consultant) and the voting results in a draw, the Executive Director casts the deciding vote. The decision of this appeal Special Panel will be final.


7. SPECIAL PANEL RECOMMENDATIONS AND PENALTIES FOR VIOLATIONS OF THE CODE


7.1. If a violation of the Code is established by a Special Panel, it may recommend on the need to take appropriate measures to eliminate the violation and impose by AIPM the following sanctions:

  • Oblige employees of the violating company to complete an online training session on the Code;
  • Inform the parent company of the company about the violation;
  • In the case of a serious violation, impose a financial fine in an amount not to exceed the current AIPM annual membership fee, which shall be used in a manner to be decided by next General Meeting of the AIPM
  • Make the fact of the violation public on the AIPM website, including, but not limited to, the identity of the offending company, if the violation is serious or repeated. This posting shall remain on the AIPM website for three months. A violation is considered repeated if it is committed within 24 months of the initial violation involving the same pharmaceutical product, or a similar violation but with another pharmaceutical product.
  • Recommend to the General Meeting the expulsion of the firm concerned from AIPM. Expulsion from the AIPM does not release the expelled or withdrawing member company from its financial obligations, nor does it release the company from the duty to pay a fine imposed;
  • A combination of the possibilities mentioned above.


7.2. A company declared as violating the Code by virtue of a decision must notify AIPM of measures taken to implement the Special Panel decision within the time period set by the Special Panel. If AIPM does not receive the relevant notice, and also if the violation is not eliminated within the prescribed period, the AIPM Executive Director shall send the company a reminder. If AIPM does not receive this notice within ten business days from the time the company receives the reminder, the AIPM Executive Director is entitled to contact the company’s headquarters and inform that the company has not taken measures to eliminate the violation or the violation has not been eliminated.


7.3. Decisions made by Special Panel with respect to each dispute are to be published on the AIPM website. Unless the publication of a name of offending company is applied as a sanction for the offence as described above, these publications should not include names of the relevant companies.


7.4. The Executive Director shall present each General Meeting of the AIPM with a report listing the number of disputes reviewed since the previous General Meeting, describing their general nature and specifying the relevant decisions made. The report shall identify the companies found to have been in material breach of the AIPM Code. The Executive Director, in consultation with the parties to the dispute, may decide to include into the report information about the general nature of the dispute and about the results of the meeting held for an independent resolution of the dispute between the parties through the mediation of the AIPM.