Ethical Code

OPERATING PROCEDURES OF THE CODE OF CONDUCT OF PHARMACEUTICAL INDUSTRY IN SLOVAKIA

1. USE AND PURPOSE OF THE COMPLAINT PROCEDURE

The Code of Conduct of Pharmaceutical Industry in Slovakia complaint procedure is open to any member of the healthcare professions, a company or the public, acting in good faith within the spirit and intentions of the Code.

In implementing the Code, the Committee is primarily concerned with education and directing the behaviour of Members in such a way as to maintain and enhance the reputation of the Pharmaceutical Industry in the Slovak Republic. Thus, the Complaints Assessment Procedure is intended to be as fair and consultative as possible and to provide an opportunity for companies to take steps to improve their behaviour wherever necessary. However, in order for the application of the Code to be taken seriously, the imposition of penalties will be necessary on occasion, and will be applied in the event of serious, deliberate or repeated breaches of the Code.

1.1. Plaintiff and Defendant

1.1.1 A plaintiff, for the purposes of this Code, is the company submitting a complaint.

1.1.2. A defendant, for the purposes of this Code, is the company being complained about (company which is alleged to be in breach of the Code).

1.2. Submission of Complaints

1.2.1. A complaint concerning the activities of a ADL, GENAS or SAFS Member which are alleged to be in contravention of the Ethical Code can be submitted by any of:

a) ADL, GENAS or SAFS member company
b) a healthcare professional
c) a member of the public
d) government official or body

1.2.2. In the event where no formal complaint about behaviour of a Member is made to the Ethical Committee, but where the activities of a Member are attracting publicity which is deemed inconsistent with the Ethical Code, then the Ethical Committee retains the right to invite the Member to a meeting of the Committee to consider whether the Code has been breached or not.

1.2.3. Complaints must be filed in writing in Slovak language with the copy in English language (obligatory) and must contain the following:

• Identity of the plaintiff comprising of its registered business name, address of its registered office, its mailing address (if it differs from the address of its registered office), including fax number and e-mail, if available.
• The full address of headquarters of a plaintiff company and the name of the responsible Regional Manager.
• Identity of the defendant comprising of its registered business name, address of its registered office, its mailing address (if it differs from the address of its registered office), including fax number and e-mail, if available.
• For each case in the complaint, the name of any product or products which are specifically involved.
• Reference material which shall be used as an evidence of the alleged breach of the Code.
• For each case in the complaint, a specific reference to the source of the activity which is the matter of the complaint and/or printed material or other evidence.
• The date of learning of the alleged breach of the Code.
• Date of filing of the complaint.
• A specific reference to the part of the Code under which the complaint is being made (section and paragraph number(s)).
• For each case, a brief description of the complaint is necessary.

1.2.4 All correspondence should be addressed to association which currently administers the Ethical Committee. The actual addresses are available on the following web pages of Member associations:

www.adl.sk
www.safs.sk
www.genas.sk

2. The procedure for filing Code related complaints

2.1. Validation and Referral of the Complaint

2.1.1. A complaint shall be filled with the Ethical Committee after a company-to-company negotiation was unsuccessful.

2.1.2. When a complaint, alleging a breach of the Code is received by Ethical Committee, it is first validated to ensure that:

• it appears to be a real case, submitted in a good faith,
• there is sufficient information to enable the complaint to be processed

2.1.3. A single complaint may cover more than one case, i.e. the complaint may refer to several advertisements from different subjects of complaint and/or for different products. Each case is handled separately by Ethical Committee under the main complaint reference.

2.1.4. The first action in each case is to identify:

• the defendant, its membership in ADL, GENAS or SAFS, its the head office or parent company and its location, if different,
• when a case refers to a company which does not belong (either locally, or through its parent company) to a Member association of ADL, GENAS or SAFS, the case cannot be processed formally. The Ethical Committee can express its opinion concerning the behaviour of the non-member company.

2.1.5. The Ethical Committee will inform headquarters and responsible Regional Managers of both companies (plaintiff and defendant) in the case that the complaint was accepted for further proceeding. Final decision will be send to headquarters of both companies as well.

2.2. Time Limits

2.2.1. Upon receiving the copy of the complaint from the Ethical Committee, the defendant shall have fifteen working days to submit its statement or comments in writing to the Ethical Committee. Under exceptional circumstances, an extension of the time limits may be allowed by the Ethical Committee.

2.3. Response

2.3.1 Where the defendant acknowledges that it has acted in breach of the Code, the information is required on the action that has been taken or will be taken to remedy the breach, e.g. amicable solution by an agreement between involved parties.

2.3.2. Where the allegations are rejected by the defendant, the reasons for such rejection must clearly be stated and, where appropriate, supporting data (e.g. scientific evidence to support claims which have been questioned) shall be provided by the defendant to the Ethical Committee within fifteen working days from the receipt of the complaint.

2.3.3. The defendant shall provide the Ethical Committee with the full address of headquarters of its company and the name of responsible Regional Manager (including his/her e-mail address) within fifteen working days from the receipt of the complaint.

2.4. Adjudicating of Complaints, Rulings

2.4.1. After receiving the statement from the defendant, the Ethical Committee shall process the complaint during its next meeting. Both involved parties shall be invited to this meeting to present their statements.

2.4.2. The Ethical Committee shall decide whether the Code was breached and how the breach will be defined (for listing of the different breaches see Annex - Glossary). The Ethical Committee shall advise the plaintiff and the defendant on its ruling without any undue delay.

2.4.3. If the Ethical Committee rules that the Code was breached, the defendant has fifteen working days to provide the Ethical Committee a written undertaking that the promotional activity or use of the material in question will cease forthwith and that all possible steps will be taken to avoid a similar breach of the Code in the future. This undertaking must be signed by the General Manager of the defendant or the appointed representative to ADL, GENAS or SAFS and must be accompanied by the details of the actions taken by the defendant to implement the undertaking, including the date on which the promotional material was finally used or appeared and/or the last date on which the promotional activity took place.

2.5. Procedure of the Appeal

2.5.1. In the event that the Member does not accept the ruling of the Ethical Committee, it has the right to appeal and submit its arguments supporting its position to a joint meeting of the Ethical Committee and ADL, GENAS and SAFS Board representatives (hereinafter referred to as the “Appeal Board”).

2.6. Rulings of the Appeal Board

2.6.1. An appeal must be lodged within fifteen working days from the notification of the ruling of the Ethical Committee and must be accompanied by reasons as to why the Ethical Committee ruling is not accepted. These reasons shall be circulated to the Appeal Board.

2.6.2. After receiving an appeal the Appeal Board shall meet during the next four weeks.

2.6.3. The representatives of the Ethical Committee and involved parties are invited to the meeting to present their statements.

2.6.4. Where the Appeal Board rules that there is a breach of the Code, the defendant shall be advised in writing on such ruling and shall be given the reasons of such a decision. The defendant then has ten working days to provide a written undertaking providing the information specified in Section 2.3.1 above.

2.6.5. Where the Appeal Board rules that there is no breach of the Code, the plaintiff and the defendant are advised on the ruling in writing.

2.6.6. The decision of the Appeal Board is final. Not even ADL, GENAS or SAFS Board can change it.

2.6.7. In the event a company does not accept the ruling and does not fulfil the required actions, ADL, GENAS or SAFS Board has to submit a proposal for expelling the respective company during the next general assembly of the association.

Typical Decisions and Actions Taken:

The following examples indicate some of the typical responses that the Ethical Committee may adopt:

A.1
Decision:
The complaint is not justified.

Action:
Reply to the plaintiff advising that the complaint is not justified and explaining reasons for this decision. Request the plaintiff to provide more evidence if it is not satisfied with the decision.

A.2

Decision:
There is insufficient evidence to judge complaint.

Action:
Reply to the plaintiff requesting more information.

A.3

Decision:
The complaint is justified, but is of a minor nature and it is the first offence by the ADL, GENAS or SAFS member company.

Action:
Advise ADL, GENAS or SAFS member involved of the Ethical Committee’s decision. The company would be requested to write and confirm that it:
i. accept the Committee’s decision;
ii. agree not to repeat the offending activity;
iii. write and apologise to the plaintiff.
If ADL, GENAS or SAFS member company does not agree with the ruling of the Ethical Committee, it shall have the right to appeal and present its case directly to the meeting of the Appeal Board.

A.4

Decision:
The complaint is justified, but is of a major nature or it is the repeated offence by ADL, GENAS or SAFS member company committed within past 2 years.

Action:
Write to the Area Director, Medical Director or CEO of ADL, GENAS or SAFS member parent company on the Committee’s findings and request that they confirm that they:

1. accept the Committee's decision;
2. agree not to repeat the offending activity;
3. apologise in a public form determined by the Ethical Committee.

If ADL, GENAS or SAFS member parent company does not agree with the ruling of the Ethical Committee it shall have the right to appeal and present its case directly to the meeting of the Appeal Board.

3. GENERAL PROVISIONS

3.1. Enforcing of the Code

3.1.1. The enforcing of the Code shall be supervised by the Ethical Committee which shall be responsible to the ADL, GENAS and SAFS Boards. Expert advice may be sought externally by the Ethical Committee in reaching a decision as to whether or not a breach of the Code has occurred.

3.2. Issue of a 6-month report

3.2.1. The Ethical Committee shall prepare a 6-month report and distribute it to all ADL, GENAS and SAFS member companies. The Ethical Committee can recommend to publish this report. This report shall contain the following information:

a) the section of the Code which was breached and the reasons for the breach,
b) the sanctions imposed for the breach,
c) the total number of complaints received and the totals from the various sections of the industry,
d) the total number of breaches,
e) the total number of appeals and the outcome of these appeals.

3.3. Fines

3.3.1. Imposing a fine by the Ethical Committee upon the defendant is fully in accordance with the Code’s provisions. The fine shall be paid by the defendant within thirty days of being advised on the ruling, provided that the ruling is either unappealable or the defendant decides not to file an appeal or fails to file an appeal in the time limit specified in Section 2.6.1 above.

3.3.2 The schedule of fines for breaches under the Code shall be as follows:

Breach Fines

Minor Breach* up to 50 000,- SKK

Moderate Breach* up to 100 000,- SKK

Severe Breach* up to 200 000,- SKK

Repeat of Previous Breach* up to 500 000,- SKK
(within past 24 months)

Breach Repetitions * Fine for repetion of previous breach is always two times higher but the maximum fine is 500 000,-SKK

3.3.3 If the Ethical Committee believes that a breach of the Code warrants the suspension or the expulsion of the Member, it will make such a recommendation to the ADL, GENAS or SAFS Board. The Board may then impose the following sanctions:

• suspension of the Member from the association for a certain period of time,
• expulsion of the Member from the association.

3.3.4. ADL, GENAS and SAFS shall approve both the above sanctions according to their Statutes.

Glossary

"Minor breach" is a breach of this Code that has no safety implications to the patient's wellbeing and will have no major effect on how the medical profession will prescribe the product.

"Moderate Breach" is a breach of this Code that has no safety implications to the patient's wellbeing but may have an effect on how the medical professional will prescribe the product.

"Severe breach" is a breach of this Code that will have safety implications to the patient's wellbeing and/or will have a major effect on how the medical profession will prescribe the product.

"Repeat of previous breach" means where the same or similar breach is repeated in the promotion of a company which had been found in breach in the preceding 24 months.

"Breach repetitions"means when a Member repeats the same breach within a period of 12 months in the promotion of any of the Member's products.

EXPLANATORY NOTES

ADL, GENAS and SAFS member company which breached the Code should be obliged by the Ethical Committee to pay the additional membership fee. Amount of this additional fee shall be determined by the Ethical Committee and should be paid within 30 days after delivery of the decision to the defendant.

GLOSSARY

In this Code:

"Association" means the Slovak Association of Research Based Pharmaceuticals Companies (SAFS), ADL, GENAS – full translated names

"Brand name reminders" means such items of low monetary value which are intended to remind healthcare professionals of the existence of a product.

"Breach repetitions" means when a Member repeats the same type of breach within a period of 12 months in the promotion of any of the Member's products.

"Breaches where activities have ceased" means severe breaches of this Code where the promotional activity has been completed before the breach has been found.

"Change of clinical significance" is any change in the Product Information that could alter a decision to prescribe or not to prescribe the product and may include the following:

(a) Approved indications for use
(b) Precautions for use
(c) Contra-indications
(d) Warnings
(e) Adverse effects and interactions
(f) Available dosage forms
(g) Dosage regimens and routes of administration
(h) Dependence potential
(i) Reference to special groups of patients (where necessary)

"Company Commissioned article" means an article or series of articles which is paid for by a Member which represents the independent opinion of a third party and/or has the appearance of editorial material.

"Company representative" are those persons, including medical representatives, authorised by a Member to disseminate information about a product to healthcare professionals.

"Congress" means an event sponsored and/or organised by a Society, College, university or other non-company entity.

"Correct" means balanced representation of all the available data.

"Data on File" is that body of unpublished clinical or scientific information held by a company. It does not include evaluated data submitted to SUKL in accordance with the Czech Guidelines for the Registration of Drugs or preceding Guidelines.

"Educational material" means any representation or literature which is intended to provide information about a medical condition or therapy which does not contain specific promotional claims.

"Evaluated data" means data which have been submitted as part of an application for marketing in accordance with the Czech Guidelines for the Registration of Drugs which form the basis for registration of a product by the SUKL

"Executive Officer" means that person appointed to manage the affairs of the Association in accordance with the Rules of the Association.

"Full advertisement" means an advertisement that requires the full or abridged Product Information to be included as set out in Section 2.1 of this Code.

"General Public" are persons other than healthcare professionals.

"Graphics" means the use of any pictorial or graphical representation in promotional material, including photographs, drawings, x-rays, graphs and bar charts, but excludes any related promotional text.

"Healthcare professions and healthcare professionals" includes members of the medical, dental, pharmacy or nursing professions and any other persons who in the course of their professional activities may prescribe, supply or administer a medicine.

"Information" means educational facts regarding the attributes of a product.

"Industry" means Members of SAFS

"INN" means International Non-proprietary Name

"International congress" means a congress held in Czech republic where a Society or College in another country is actively organising and has joint control over the conference with an Czech Society or College.

"Journal" means a serial publication whose distribution is restricted to the members of the healthcare professions.

"Literature" means that body of published trials, findings and reviews which have appeared in medical and scientific publications.

"Mailings" means promotional material designed for distribution through the postal system or by private means.

"Manufacturer" includes the manufacturer, importer or Slovak distributor of a pharmaceutical product.

"Market research" is the gathering of data on the scope or dimensions of a market and its components, including the needs of the customers in that market.

"Medical claims" means any statement which conveys the attributes of a product in respect of its therapeutic use, that is, a use for the purpose of or in connection with -

(a) preventing, diagnosing, curing or alleviating a disease, defect or injury in man;
(b) influencing, inhibiting or modifying a physiological process in man;
(c) testing the susceptibility of man to a disease or ailment; or
(d) destroying or inhibiting micro-organisms that may be harmful to man.

"Medical content " means that portion of promotional material which makes a medical claim.

"Medical representative" means a person expressly employed by a company whose main purpose is the promoting of the company's products to healthcare professionals.

"Member" means any person, firm or company holding Ordinary or Associate membership of SAFS., as defined by Statutes of the Association.

"Minor breach" is a breach of this Code that has no safety implications to the patient's well-being and will have no major effect on how the medical profession will prescribe the product.

"Moderate Breach" is a breach of this Code that has no safety implications to the patient's well-being but may have an effect on how the medical professional will prescribe the product.

"New chemical entity" means a product containing an active substance which has not been previously included in a product approved for registration in Czech republic for human use, including new combinations, salts or esters of previously marketed substances.

"New indication(s)" means an additional indication for the drug which was approved by SUKL after the original registration of the drug.

"Post-marketing surveillance studies" means research intended to generate data of a product that has been approved for registration when used in accordance with the approved Product Information.

"Product" means any compound and/or delivery method that is approved.

"Product Information" means a document containing information about the product (Summary of Product Characteristics or Patient Information Leaflet) which is compiled in the SUKL Guidelines for the Registration of Drugs or subsequent revision. Product information can be full or abridged (see 2.2. of the Code)

"Promotion" , "Promotional" or "Promotional claim" means any statement made by a Member or Member's representative, whether verbal or written or recorded, which conveys the positive attributes of a product which extend beyond a simple non-qualitative or quantitative description of the therapeutic category or approved indication for the purpose of encouraging the usage of that product. It includes statements concerning efficacy, rate of adverse reactions or other cautionary aspects of the product and comparative information.

"Promotional material" means any representation concerning the attributes of a product conveyed by any means whatever for the purpose of encouraging the usage of a product.

"Reference manual" is a serial or monographic publication designed by its publisher to provide information in classified sequence for the purposes of ready reference to pharmacological or medical data.

"Registration" is the issue by the Ministry of Health and SUKL of an Czech registration number for a product approved for marketing in Slovak rep.

"Repeat of previous breach" means where the same or similar breach is repeated in the promotion of a particular product of a company which had been found in breach in the preceding 24 months.

"Rules" means the Rules of the Association for the time being in force. .

"Severe breach" is a breach of this Code that will have safety implications to the patient's well-being and/or will have a major effect on how the medical profession will prescribe the product.

"Samples" means a quantity of a product supplied without cost to physicians.

"Sponsored Symposia or Workshop" means a scientific meeting sponsored by a Member as an independent event or as a satellite to a congress.

"Substantiation" means to give reasonable grounds in support of a promotional claim. Substantiating information should conform with the requirements of Section 1.3, and must not rely solely on data on file.

"Therapeutic class" means the classification system used for defining and grouping products in an approved reference manual.

"Therapeutic class number" means the system of notation used in an approved reference manual.

"Trade display" means a display or exhibit of promotional or educational material about a product or products.

"Trade pack" means a package of a product which is sold by the Member.

"Type size" means the height of a lower case letter "o".

"Unique" means being the first, different from all others and the only one of its class on the Slovak market.

"Working hours" meaning is standard 8.5 hour working day.

<< Back |