Ethical Code valid from January 1, 2008

CODE OF CONDUCT OF THE PHARMACEUTICAL INDUSTRY IN SLOVAKIA

Preface
Preamble

1. Nature and Availability of Information and Claims
1.1 Responsibility
1.2 Provision of Substantiating Data
1.3 False or Misleading Claims
1.3.1 Unapproved products and indications
1.4 Good Taste
1.5 Unqualified Superlatives
1.6 New Products
1.7 Comparative Statements
1.8 Imitation
1.9 Medical Ethics
1.10 Distinction of Promotional Material

2. Product Information
2.1 Full Product Information
2.2 Abridged Product Information
2.3 Changes of Clinical Significance

3. Promotional Material*
3.1 Acceptability and Legality of Promotion
3.2. Journal Advertising
3.2.1 Full advertisement*
3.2.2 Short advertisement
3.2.3 Company Commissioned Articles
3.3 Materials for use by Medical Representatives*
3.3.1 Printed promotional material
All artwork, including graphs, illustrations, photographs and tables taken from published studies included in promotional material should:
(a) clearly indicate the precise source(s) of the artwork
3.3.2 Audio-visual promotional material
3.3.3 Brand name reminders*
3.3.4 Medical literature/reprints
3.3.5 Computer Based Promotional Material
3.4 Mailings*
3.5 Document Transfer Media
3.6 Promotional Competitions

4. Medical Representatives

5. Product Samples

6. Trade Displays

7. Travel and Sponsorship

8. Research
8.1 Non-interventional clinical trial (NCT)
8.2 Other studies

9. Relations with Healthcare Professionals
9.1 Hospitality
9.2 Medical Educational Material
9.3 General Renumeration
9.4 Gifts and Inducements

10. Public and Media Relations
10.1. No advice on personal medical matters
10.1 Press releases
10.2 Press Conferences
10.3 Radio and TV
10.4 Hospitality and Incentives

Glossary - ANNEX of the Code of Conduct of Pharmaceutical Industry

Preface

The pharmaceutical industry* promotes the concept of good health, and a positive, health-oriented approach to daily living. Recognising that medicines play a vital role in the prevention, amelioration and treatment of disease states, the industry undertakes:

• to provide medicines that conform to the highest standards of safety, efficacy and quality;
• to ensure that medicines are supported by comprehensive technical and informational services in accordance with currently accepted medical and scientific knowledge and experience;
• to use professionalism in dealing with healthcare professionals*, public health officials and the general public.

The industry is committed to the quality use of medicines and rationale prescribing, and supports that its products be used in accordance with the directions and advice of healthcare professionals. To ensure that the information* is available upon which to make informed prescribing decisions, it is necessary for the manufacturer* to disseminate to healthcare professionals the specialised product information gained during the research and development process, and from experience gained in clinical use. In doing so, the manufacturer draws attention to the existence and nature of a particular product* by appropriate educative and promotional measures.

With the full cooperation of the industry, there is now adequate legislation designed to safeguard the public by ensuring that all products marketed meet standards of quality, effectiveness and safety which are acceptable in the view of present knowledge and experience.

While it is possible to legislate satisfactorily for the testing, manufacture and control of medicinal products, appropriate standards of marketing conduct cannot be defined by the same means. For this reason, responsible manufacturers have concurred in the promulgation of the Code of Conduct and submitted to its constraints.

Any Member* of ADL, GENAS and SAFS undertakes to comply with the Statutes and this Code of Conduct of Pharmaceutical Industry in Slovakia (hereinafter referred to only as the "Code").

Complaints against any activity of a Member should be made to the Ethical Committee of Pharmaceutical Industry in Slovakia (hereinafter referred to as the "Ethical Committee") as provided for in the Operating Procedures.

Note:

A glossary of defined terms used in this Code is attached hereto as Annex. The first inclusion of each term defined by the glossary in the Code is always denoted by an asterisk (*).

Preamble

A. This Code sets out standards of conduct for the activities of ADL, GENAS and SAFS Member companies when engaged in the marketing of prescription-only medicinal products as permitted by the Slovak legislation. This Code owes its origin to the determination of ADL, GENAS and SAFS to secure universal acceptance and adoption of high standards in the marketing of prescription-only medicinal products for human use.
B. Acceptance and observance of the Code is a condition of membership of ADL, GENAS and SAFS, and a Member must comply with both the letter and the spirit of the Code. The Members should ensure that all employees and/or agents acting on their behalf are fully conversant with the provisions of this Code. Pharmaceutical companies outside the associations are hereby invited to accept and observe this Code.

The Code shall be supervised and exercised by the Ethical Committee. The Ethical Committee may issue determinations from time to time for the purpose of interpretation of certain sections of the Code. Complaints concerning alleged breaches of the Code should be reported to the Ethical Committee.

C. A major guiding principle of the Code is that, whenever a promotional claim* is made for a product, it shall be accompanied by the Slovak Product Information.*
D. Failure to comply with the Code will result into sanctions being applied under provisions of the Operating Procedures. Adherence to this Code in no way reduces Members´ responsibilities to comply with the Slovak legislation and Codes, including the EFPIA Code. Promotion* of prescription-only medicinal products to the general public is prohibited by law.

PROVISIONS OF THE CODE

1. Nature and availability of information and claims

1.1 Responsibility

It is the responsibility of Members, their employees and their medical/technical advisers to ensure that the medical content* included in all promotional material* is true, correct*, accurate, updated, verifiable and fully supported by the product information, literature* or Data on File*, where the latter do not conflict with the former. Activities of company representatives* must comply with the Code at all times.

EXPLANATORY NOTES

1.1

This responsibility relates not only to the product being promoted, but to any information given or claims made about other products.
Of importance is that any claim made must be consistent with the Slovak Product Information document, irrespective of the source on which the claim is based.

1.2 Provision of Substantiating Data

Further to the information compulsory supplied or generally available, the manufacturer will, upon reasonable request, provide healthcare professionals with additional accurate and relevant information about products which it markets.

Substantiating information must not rely solely on Data on File.

Data cited in promotional material in support of a claim, including Data on File or "in press" must be made available to healthcare professionals and the industry companies upon request.

EXPLANATORY NOTES

1.2

(a) All data to substantiate claims must be easily retrievable so that they could be supplied on request within 10 working days.
(b) Evaluated data* contained in an application for marketing in accordance with the Slovak Guidelines for the Registration of Drugs or preceding Guidelines as the basis of the registration* of the product by the State Institute for Drug Control - ŠÚKL may be used to substantiate claims. Such data must be supplied in detail when requested to substantiate a claim. A statement that the data are "Confidential" will not be accepted.
(c) If the information on which a claim is based may not be released, e.g. an "in press" article which is subject to confidentiality provisions, then that information may not be used to substantiate a claim for the purposes of satisfying this section.
(d) Data relating to the cost effectiveness of a product may be used to substantiate promotional claims, however, these data must conform to Sections 1.1, 1.2, 1.3, 1.5 and 1.7 of this Code.

1.3 False or Misleading Claims

Information, medical claims* and graphical representations about products must be current, accurate, balanced and must not mislead either directly, by implication, or by omission.

Information, claims and graphics* must be capable of substantiation*, such substantiation being provided without delay at the request of health professionals.

EXPLANATORY NOTES

1.3

The majority of breaches of the Code which have been ascertained concern this section. The following are examples of situations where promotional material may breach the Code. This list is not all inclusive and is based on the experience of the Ethical Committee.
(a) Literature references or quotations derived from a study or studies and citations of individual opinions which are significantly more favourable or unfavourable than has been demonstrated by the body of clinical evidence or experience. It is unreasonable to cite the results of an excessively favourable (or excessively unfavourable to a comparative product) study in a manner which suggests that those results are typical and may mislead.
(b) Information or conclusions from a study that is clearly inadequate in design, scope or conduct to furnish support for such information and conclusions.
(c) Citation of data previously valid but made obsolete or false by the evaluation of new data.
(d) Suggestions or representations of uses, dosages, indications or any other aspect of the Product Information not approved by ŠÚKL.
(e) Shortening an approved indication (e.g. in a by-line) so as to remove a qualification or limitation to the indication.
(f) Use of animal or laboratory data to directly support a clinical claim.
(g) Presentation of information in such a manner e.g. Type size* and layout, which, to the casual reader could produce an incorrect perspective. The type size used for qualifying statements must not be less than 2 mm. The qualifying statement must not be included with other reference material but must be situated on the same page as the original statement. The original statement and the qualifying statement must be linked by use of an asterisk or a similar symbol.
(h) Statements made about a competitive product, particularly negative statements, not balanced with corresponding information about the product being promoted.
(i) Shortening the title of graphical representations reproduced from literature which alters the original author's meaning.
(j) Use of foreign Product Information to support a claim where that information is inconsistent with the Slovak Product Information.
(k) Literal or implied claims that a parameter, subject to a warning, precaution or adverse reaction in the product information, is not cause for concern.
(l) Lack of substantiation of claims not of a medical or scientific nature. It includes information or claims relating to marketing factors such as pricing and market share. Care should be taken when extrapolating prescribing practices from sales data.

It should be noted that if animal or laboratory data are used a prominent statement identifying this type of data must be made on the same page and within reasonable proximity of the data in a manner that is not obscured by other material.

1.3.1 Unapproved products and indications

Products that have not been approved for registration by ŠÚKL must not be promoted. However, samples of unapproved products may be displayed and educational material* made available at International Congresses* and local Congresses in accordance with Section 6 hereof. This restriction also applies to unapproved indications for registered products.

1.4 Good Taste

Promotional material (including graphics and other visual representations) should conform to generally accepted standards of good taste and recognise the professional standing of the recipients.

1.5 Unqualified Superlatives

Unqualified superlatives must not be used. Claims must not imply that a product or an active ingredient is unique* or has some special merit, quality or property unless this can be substantiated. The word "safe" must never be used to describe the product without proper qualification. It must not be stated that a product has no side-effects, toxic hazards or risks of addiction or dependency.

1.6 New Products

The word "new" must not be used to describe any product, presentation, or therapeutic indication which has been available and generally promoted for more than 12 months in the Slovak Republic.

1.7 Comparative Statements

Comparison of products must not be misleading or disparaging. It must be factual, fair, based on relevant and comparable aspects of the products and be capable of substantiation and referenced to its source. In presenting a comparison, care must be taken to ensure that it does not mislead by distortion, by undue emphasis or in any other way. "Hanging" comparatives - those which merely claim that a product is better, stronger, more widely prescribed etc. - must not be used.

Data on File, when used to substantiate comparative statements, must comply with the requirement of Section 1.2 hereabove.

EXPLANATORY NOTES

1.7

Where a claim of comparative efficacy or safety is made, it must not be based solely on a comparison of product information documents that does not reflect the general literature, as those documents are based on different databases and are not directly comparable. This applies to Slovak as well as foreign Product Information Documents.
Claims of comparative efficacy or safety should be substantiated with respect to all aspects of efficacy or safety. Where a comparative claim relates to a specific parameter, any claims must be clearly identified as pertaining to that parameter.
The accepted level of statistical significance is p < 0.05. If comparative data that are not statistically significant are used, such data must comply with the following conditions:

• the data must be clearly identified as such by statement, not just by p value,
• the data must not be used to generalise or to indicate superiority or inferiority.

The statement that the claim is not statistically significant needs to be linked in some manner to the original claim, made on the same page and within a reasonable proximity of the original claim in a manner that is not obscured by other material using a type size of not less than 2 mm.

1.8 Imitation

Promotional information should not imitate the devices, copy, slogans or general layout adopted by other manufacturers in a way that is likely to mislead or confuse.

1.9 Medical Ethics

Doctors´ names or photographs must not be used in any way that is contrary to medical ethics.

1.10 Distinction of Promotional Material

Promotional material must be clearly distinguishable as such.

EXPLANATORY NOTES

1.10

Advertisements in a journal* should not be designed so as to resemble editorial matter unless clearly identified as an advertisement. See also sections 3.2 and 3.3 of this Code.

2. Product Information

All types of promotional material described in Section 3 must be accompanied by either full or abridged Product Information.

Wherever required, Product Information must appear in a type size of not less than 2 mm on a background sufficiently contrasting for legibility. Major headings should be easily identifiable.

Product Information must not be overprinted or interspersed with promotional phrases or graphics and must clearly identify any recent change of clinical significance*.

EXPLANATORY NOTES

2.

The full date on which the Product Information was approved and/or last updated must always be included. The same shall apply when the abridged Product Information is included.

2.1. Full Product Information

Full or abridged Product Information must accompany all promotional material in the Slovak Republic.

2.2. Abridged Product Information

Abridged Product Information may be used in medical publications.

2.2.1
Abridged Product Information must accurately reflect the full Product Information but may be a paraphrase or précis of the full Product Information.

2.2.2
Under the heading "Abridged Product Information", the following shall appear:

(a) Approved indications for use;
(b) Contra-indications;
(c) Clinically significant warnings;
(d) Clinically significant precautions for use;
(e) Clinically significant adverse effects and interactions;
(f) Available dosage forms;
(g) Dosage regimens and routes of administration;
(h) Dependence potential of clinical significance;
(i) Reference to special groups of patients.

Where the full Product Information does not include items under these headings, such headings are not required to be included in the document.

2.3 Changes of Clinical Significance

2.3.1
Where a change of clinical significance relating to product safety is incorporated into the Product Information, it should be indicated in all representations of the Product Information for a period of 12 months from the date of change by an asterisk(s) to a footnote in type size of not less than 2 mm: "Please, note change(s) in product information."

2.3.2
The full text of the changed section should be included in any abridged Product Information during this period.

2.3.3
Where a Member is not actively promoting the product, written advice of the change to Product Information should be forwarded to the appropriate healthcare professionals.

3. Promotional Material*

3.1. Acceptability and Legality of Promotion

3.1.1
The Members must maintain high ethical standards at all times. The promotion must:

• never be such as to bring discredit upon, or reduce confidence in, the pharmaceutical industry;
• be of a nature which recognises the special nature of medicines and the professional standing of the recipient(s);
• not be likely to cause offence.

3.1.2
Unless this Code explicitly provides otherwise, a medicinal product must not be promoted prior to granting it the marketing authorisation allowing its sale or supply or outside of its approved indications.

3.1.3
Promotion must be accurate, balanced, fair, objective and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the medicinal product concerned. It should be based on an up-to-date evaluation of all relevant evidence and reflect that evidence clearly. It must not mislead by distortion, exaggeration, undue emphasis, omission or in any other way.

3.1.4
Promotion must encourage the rational use of medicinal products by presenting them objectively and without exaggerating their properties. Claims must not imply that a medicinal product, or an active ingredient, has some special merit, quality or property unless this can be substantiated.

3.1.5
Promotion must always be consistent with the particulars listed in the Product Information of the relevant medicinal product.

3.1.6
Any promotion or information on drugs addressed to the healthcare professionals (hereinafter referred to as "providing of information to healthcare professionals") may be performed or provided only by persons professionally capable to handle the drugs appointed by the drug registration holder. When providing information to healthcare professionals, the aforesaid appointees shall be obliged to provide also the Product Information, information on price of the drug and on its reimbursement by a health insurance company. When providing information to healthcare professionals, it shall be prohibited to donate, offer or promise a monetary or material advantage to healthcare professionals and their close persons.

3.1.7
According to Slovak legislation, any promotion of medicinal products other than the promotion which is subject to an exemption from the statutory ban on advertising of drugs (Sec. 8 par. 7 of the Act No. 147/2001 Coll. on Advertising, as later amended) shall be illegal.

3.1.8
Any Promotional Material must under any circumstances conform to all requirements of acceptability and legality of promotion set forth in this Section 3.1.

3.2. Journal Advertising

Journal Advertising must conform to the requirements of one or other of the following categories. The information required shall appear in each publication in a type size of not less than 2 mm, and should appear on a background sufficiently contrasting for legibility.

EXPLANATORY NOTES

3.2

Care should be taken to ensure that where an advertisement consists of a double sided or multiple page copy, the information contained on each individual page is not false or misleading when read in isolation.

3.2.1 Full advertisement*

3.2.1.1
A full advertisement must contain the following within the body of the advertisement.

(a) the brand name of the product,
(b) the INN* of the active ingredient(s),
(c) the name of the registration holder and its mailing address in Slovak Republic,
(d) the full or abridged Product Information.

3.2.1.2
A full advertisement is mandatory for the advertising of all new chemical entities* or the advertising of new indications for 12 months from the date of their first advertising in medical publications, or longer at the discretion of the advertiser.

3.2.1.3
The Product Information should be placed adjacent to the body of the advertisement. Where it is not practicable to do so, the advertisement must carry a statement in type size not less than 2 mm to the effect of the following statement:
"Please review Product Information before prescribing. In this publication, product information can be found ...."

At the point ..., insert the page number in the publication where the information can be found or reference to an adequately referenced product information section or advertisers index.

Product Information should always form a fixed part of the journal.

EXPLANATORY NOTES

3.2.1.1

(b) The INN should appear adjacent to the most prominent presentation of the trade name.
(d) See Sections 2.1., 2.2. and 2.3.

3.2.1.4
The use of an abridged Product Information shall be permitted only after 12 months from the first advertising of a new chemical entity in medical publications.

3.2.1.5
The abridged Product Information should be placed adjacent to the body of the advertisement. Where it is not practicable to do so, the advertisement will carry a statement in not less than 2 mm type size, to the effect of the following statement:
"Please review product information before prescribing. In this publication, product information can be found ..."

At the point ..., insert the page number in the publication where the information can be found or reference to an adequately referenced product information section or advertisers index.

Product Information should always form a fixed part of the journal.

3.2.2 Short advertisement

3.2.2.1
A short advertisement is designed to remind a prescriber of a product´s existence, and must not contain promotional claims. The sole use of a short advertisement within any one issue of a publication is not permitted before 12 months from the first advertising of a new chemical entity or before elapsing 12 months following a change of clinical significance made to the Product Information.

3.2.2.2
A short advertisement must contain:

(a) the brand name of the product,
(b) the INN of the active ingredient(s),
(c) the name of the registration holder and its mailing address in the Slovak Republic,
(d) a statement to the effect that further information is available on request from the supplier.

3.2.2.3
A short advertisement may contain:

(a) up to 5 words describing therapeutic class* , but without the use of promotional phrases,
(b) graphics,
(c) a statement of available dosage forms,
(d) a statement referring to the location of product information in a reference manual.

No other material or information shall be permitted.

EXPLANATORY NOTES

3.2.2.2

(b) The INN should appear adjacent to the most prominent presentation of the name.

3.2.3. Company Commissioned Articles

3.2.3.1
Company Commissioned Articles must be identified as such in a type size of not less than 2 mm.

3.2.3.2
The Member which is responsible for the insertion of the Company Commissioned Article must be clearly identified at either the top or the bottom of the Company Commissioned Article in a type size of not less than 2 mm.

3.2.3.3
Company Commissioned Articles must conform to all relevant provisions of Sections 1 and 3.1 of this Code. Company Commissioned Articles shall also conform to the requirements of sections 3.2.1 and 3.2.2 of this Code

EXPLANATORY NOTES

3.2.3

Sponsoring companies should ensure that statements by third parties which are quoted in Company Commissioned Articles comply with these requirements.
Independently edited supplements which publish the proceedings of a recognised congress* are not considered as Company Commissioned Articles. It is recommended that if a company sponsors such a supplement this should be stated clearly in the supplement.

3.3. Materials for use by Medical Representatives*

A major guiding principle of the Code is that, whenever a promotional claim is made for a product, it shall be accompanied by the Product Information, as provided for in Section 3.1 of this Code. Where multiple forms of promotion items are intended to be distributed at one time, the Product Information must appear at least once.

3.3.1 Printed promotional material

3.3.1.1
All Member printed promotional material must include the following information:

(a) the brand name of the product,
(b) the INN of the active ingredient(s),
(c) the name of the registration holder and its mailing address in Slovak Republic,
(d) full or abridged Product Information,
(e) the date of the issuing or of the revision.

3.3.1.2
Where it is impractical to print the Product Information on the body of the promotional material, the promotional material will carry a statement to the effect of the following in a type size of not less than 2 mm:
"Please review Product Information before prescribing. Product information accompanies this item."

The item is then to be accompanied by a full or abridged Product Information.

3.3.1.3
All artwork, including graphs, illustrations, photographs and tables taken from published studies included in promotional material should:
(a) clearly indicate the precise source(s) of the artwork;
(b) be faithfully reproduced; except where adaptation or modification is required in order to comply with any applicable code(s), in which case it must be clearly stated that the artwork has been adapted and/or modified.

Particular care must be taken to ensure that the artwork included in promotion does not mislead about the nature of a medicinal product (for example whether it is appropriate for use by children) or mislead about a claim or comparison (for example by using incomplete or statistically irrelevant information or unusual scales).

EXPLANATORY NOTES

3.3.1
This section applies to detail aids, leaflets, posters and other materials prepared based on the available literature and intended for distribution to healthcare professionals, which contain promotional claims.

3.3.1.1.

(b) The INN should appear adjacent to the most prominent presentation of the trade name.
(d) See Sections 2.1, 2.2 and 2.3.

3.3.1.2.
The wording used to direct the reader to the location of product information may be varied but must contain a direction to review the product information before prescribing the product.

3.3.2 Audio-visual promotional material

3.3.2.1
All audio-visual promotional material must be accompanied by a document which contains the following information.

(a) the brand name of the product,
(b) the INN of the active ingredient(s),
(c) the name of the registration holder and its mailing address in Slovak Republic,
(d) full or abridged Product Information.

3.3.2.2
Where an audio-visual item is demonstrated, the Product Information document must be given to the individual reviewing the promotional material, or offered to the audience in a group situation on completion of the presentation.

EXPLANATORY NOTES

3.3.2
This section applies to audio-tapes and video-tapes for private use by healthcare professionals or for demonstration purposes to groups of healthcare professionals.

3.3.2.1
(b) The INN should appear adjacent to the most prominent presentation of the trade name.
(d) See Sections 2.1, 2.2 and 2.3

3.3.3 Brand name reminders*

Brand name reminders or promotional items of insignificant value provided free of charge are permissible as long as they are related to the health care provider´s work and/or entail a benefit to patients and are not provided simultaneously with providing information to healthcare professionals.

3.3.3.1
Brand Name Reminders or Promotional Items must include the following information:

(a) the brand name of the product,
(b) the INN of the active ingredient(s),
(c) name and logo of the company.

3.3.3.2
Brand Name Reminders or Promotional Items are not to contain any promotional claims/and or statements.

3.3.3.3
Where the nature of a Brand Name Reminder or Promotional Item is such that it is demonstrably and obviously impractical to display legibly the brand name of the product and the INN of the active ingredient(s) as required in Section 3.3.3.1, the Brand Name Reminder or Promotional Item must be accompanied by a document containing the information specified in Section 3.3.3.1.

3.3.3.4
Where the nature of a Brand Name Reminder or Promotional Item is such that it is demonstrably and obviously impractical to display legibly the notation "See Warning" as required in Section 2.3.1, a Brand Name Reminder or Promotional Item must not be used for that product.

EXPLANATORY NOTES

3.3.3

An individual Brand Name Reminder should only be of token value and should not bring discredit to the industry.

3.3.3.1
The INN should appear adjacent to the most prominent presentation of the trade name.

3.3.4 Medical literature/reprints

3.3.4.1
The general tenor of any reprints of journal articles, proceedings of symposia* or summaries of literature used in promotion must be consistent with the Product Information.

3.3.4.2
Quotations from medical and scientific literature or from personal communications must be faithfully reproduced, it must accurately reflect the meaning of the author and significance of the study and identify the precise sources.

EXPLANATORY NOTES

3.3.4

Healthcare professionals may request literature on subjects not covered by the Product Information such as non-approved indications. While it is not acceptable to routinely disseminate such literature where unsolicited, it is acceptable to provide such information on individual request.
Reprints themselves do not need to be accompanied by the Product Information, but the Product Information must be included with any accompanying material (e.g. letter) or presentation made which makes promotional claims.
Quotations relating to medicinal products taken from public broadcasts or private occasions such as medical conferences or symposia should not be reproduced without the written permission of the speaker unless subsequently published. Care should also be taken to avoid ascribing unpublished claims or views relating to prescription-only medicinal products to authors when such claims or views no longer represent, or may not represent, the current view of the author concerned.

3.3.5 Computer Based Promotional Material

3.3.5.1
Computer based promotional material must comply with all relevant provisions of this Code.

3.3.5.2
Where an individual product is being promoted the appropriate Product Information must be given to an individual reviewing the promotional material, readily accessible via the computer based material or offered to an audience in a group situation on completion of the presentation.

3.3.5.3
Where the Product Information is included in interactive data system, instructions for accessing it must be clearly displayed.

EXPLANATORY NOTES

3.3.5

As a minimum, this section covers the following:

• Promotional materials designed by Members to promote their products directly to healthcare professionals including such promotional tools as software programs used by Medical Representatives during interchanges with healthcare professionals.
• The use of external computer generated programs by Members to promote their products including such programs as prescribing and dispensing software.
• The use of messages on the Internet by Members. Members considering the use of the Internet should refer to Slovak law which prohibits the promotion of prescription-only medicinal products to the general public.

3.4. Mailings*

3.4.1
Mailings must comply will all relevant provisions of Sections 1 and 3.1 of this Code.

3.4.2
The full or abridged Product Information as applicable must be included in all mailings where promotional claims are made.

3.4.3
Mailings should only be sent to those categories of health professionals whose need for, or interest in, the particular information can be reasonably assumed. Requests to be removed from promotional mailing lists must be complied with promptly and no name restored except at specific request or with written permission.

3.4.4
Exposed mailings including postcards, envelopes or wrappers must not carry matter which might be regarded as advertising to the general public or which could be considered unsuitable for public view.

EXPLANATORY NOTES

3.4.1

Envelopes implying urgent attention should be restricted to matters relating to product recalls or important safety information.
Envelopes should not be used for dispatch of promotional material, if they bear words implying that the contents are non-promotional.
Unsolicited reprints of journal articles must be consistent with the product information, and any covering letter should comply with Sections 1 and 3.1 of this Code.

3.5. Document Transfer Media
Unsolicited telegrams, telexes and electronic transmissions, or replicas thereof, must not be used for promotional purposes.

3.6. Promotional Competitions

3.6.1
Promotional competitions must fulfil all of the following criteria:

(a) The competition is based on medical knowledge or the acquisition of medical knowledge.
(b) The prize is directly relevant to the practice of medicine or pharmacy.
(c) Individual prizes offered are to be of low monetary value or be an item of educational material.

3.6.2
Entry into a competition must not be dependent upon prescribing or recommending of a product and no such condition shall be made or implied.

3.6.3
The conduct of competitions shall comply in all respects with relevant Slovak regulations.

EXPLANATORY NOTES

3.6
Items suggesting requirement for urgent attention, whether by general mailing or by replicas of urgent media, e.g. statgrams, are not acceptable for promotional purposes.
The value of prizes permitted to be used in competitions is difficult to define and needs to be assessed on an individual basis.
Prizes which might be useful in the practice of medicine but are not specific to medicine or pharmacy must not be offered.

4. MEDICAL REPRESENTATIVES

4.1
Medical representatives must only use promotional material which conforms to the provisions of Section 3 of this Code. Verbal statements made about a product must comply with the provisions of Section 1 of this Code.

4.2
Members have a responsibility to maintain high standards of ongoing training for their medical representatives.

4.3
Medical representatives should possess sufficient medical and technical knowledge to present information on the company´s products in an accurate current and balanced manner and should be cognisant of all provisions of this Code.

Each Member shall ensure that its medical representatives, including personnel retained by way of contract with third parties, and any other company representatives who call on healthcare professionals in connection with the promotion of medicinal products are familiar with the relevant requirements of this Code and all applicable laws and regulations, and are adequately trained and have sufficient scientific knowledge to be able to provide precise and complete information about the medicinal products they promote.

4.4
Medical representatives should at all times maintain a high standard of ethical conduct in the discharge of their duties.

4.5
Medical representatives must not employ any deception or use any inducement or subterfuge to gain an interview. In an interview, or when seeking an appointment for an interview, medical representatives must, from the outset, take reasonable steps to ensure that they do not mislead as to their identity or that of the company they represent.

4.6
Medical representatives should ensure that the frequency, timing and duration of calls, together with the manner in which they are made, are such as not to cause inconvenience. The wishes of an individual healthcare representative, or the arrangements in force at any particular establishment, must be observed by medical representatives.

4.7
Medical representatives must not use the telephone to promote products to the healthcare professionals unless the consent of the healthcare professional has been obtained.

4.8
Wherever a promotional claim is made, the medical representative shall provide the Product Information, as well as other information required by law and this Code.

4.9
Under no circumstances shall medical representatives pay a fee in order to gain access to a healthcare professional.

4.10
Every company must establish a scientific service in charge of information about its medicinal products. This scientific service must include a doctor or, where appropriate, a pharmacist who will be responsible for approving any promotional material before release. Such person must certify that he/she has examined the final form of the promotional material and that in his/her belief it is in accordance with the requirements of this Code and any applicable laws and regulations, is consistent with the summary of product characteristics and is a fair and truthful presentation of the facts about the medicine.Under no circumstances shall medical representatives pay a fee in order to gain access to a healthcare professional.

4.11
Each company must appoint at least one senior employee who shall be responsible for supervising the company and its subsidiaries to ensure that the standards of the applicable code(s) are met.

EXPLANATORY NOTES

4.

Members should ensure that the medical representatives are familiar with the provisions of this Code. Particular attention is drawn to Section 3.3 on materials for use by medical representatives, Section 5 on samples and Seciton 6 on trade displays*.

4.5/6

Medical representatives may be used to obtain survey information in accordance with Section 8 of this Code. However, the pretext of carrying out a survey to gain an extended interview should be avoided.

4.8
Where promotional material is used during the interview, the Product Information which is required by the Code to accompany that material is sufficient to satisfy this Section.

5. Product Samples

Care should be exercised by Members that the distribution of Samples is carried out in a reasonable manner and in accordance with the valid law.

5.1
Samples may only be supplied to physicians, upon their signed and dated written requests, for their familiarisation with products. Product Information and Consumer Product Information must be supplied with the sample at the time of its distribution or included in the product package.

5.2
Sample packs should be clearly identified as such and must be labelled in the following way clearly expressing that they are medical samples, free of charge and not for sale: "Free medicinal sample - not for sale."

Each healthcare professional may receive maximally two samples of one drug per year.

5.3
Medical representatives must take adequate precautions to ensure the security of samples in their possession. Members should develop an appropriate recording system so that, if a product recall is necessary, relevant samples will be included in the recall.

5.4
Drug donation to hospitals should be at the reasonable level and should be of public knowledge.

5.5
On request, Members must promptly accept the return of samples of their products.

5.6
No samples of the following medicinal products may be supplied:
(a) medicinal products which contain substances defined as psychotropic or narcotic by international convention, such as the United Nations Conventions of 1961 and 1971; and
(b) any other medicinal products for which the supply of samples is inappropriate, as determined by competent authorities, from time to time.

EXPLANATORY NOTES

5.
Members should ensure that they are kept informed of any changes in the Slovak legislation concerning supply of samples.

5.4
Public knowledge means that a written contract, which can be seen upon request, exists.

6. TRADE DISPLAsYS

General Principle

Trade displays are important for the dissemination of knowledge and experience to the healthcare professions. The prime objective in organising such displays should be the enhancement of medical knowledge. Where hospitality is associated with symposia and congresses, it should always be secondary to the main purpose of the meeting.

6.1
Trade displays must only be directed to healthcare professionals.

6.2
A trade display must include, in a prominent position, the name of the sponsoring company.

6.3
Exhibitors must comply with all requirements of the sponsoring institution when mounting and conducting an exhibit.

6.4
Product information for products being promoted must be available from the display stand.

6.5
Samples must not be made available for collection from unattended stands, nor be supplied to unauthorised or non-qualified persons.

6.6
Competitions that are held as part of a Trade Display must be consistent with the requirements of Section 3.6 of this Code.

6.7
All promotional materials used at Trade Displays must be consistent with the requirements of Sections 1.3.1 and 3.3 of this Code.

EXPLANATORY NOTES

6.

All promotional material used at trade displays must be consistent with the requirements of Section 3.3 of this Code.
However, given the nature of attendees at international congresses held in Slovak Republic, it is acceptable at such congresses to display or supply educational material for a product not approved for registration in the Slovak republic or a non approved indication of a product registered in the Slovak Republic, provided that any display material or educational material used clearly identifies that it refers to a product or indication not approved in the Slovak Republic, and that the product or indication, as appropriate, is approved abroad.
Any appropriately worded label prominently located would be sufficient to satisfy this Section. This label must enable the reader to recognise that the product or indication is unapproved in the Slovak Republic.
Information regarding such products must be consistent with the approved Product Information in the country where the product is registered. Such Product Information must be available and distributed as per this Code.

6.5
See also Section 5 of this Code.

6.6

See also Section 3.6 of this Code.

7. TRAVEL AND SPONSORSHIP

7.1
The following shall apply to Members sponsoring delegates travelling from or within the Slovak Republic to symposia and/or congresses:

All promotional, scientific or professional meetings, congresses, conferences, symposia, and other similar events (hereinafter referred to as an "event") organised or sponsored by a Member must be held in an appropriate venue that is conducive to the main purpose of the event and may only offer hospitality when such hospitality is appropriate and otherwise complies with the provisions of this Code.

No Member may organise or sponsor an event that takes place outside The Slovak Republic unless:
(a) most of the invitees are from outside of the Slovak Republic and, given the countries of origin of most of the invitees, it makes greater logistical sense to hold the event in another country; or
(b) given the location of the relevant resource or expertise that is the object or subject matter of the event, it makes greater logistical sense to hold the event in another country.

Hospitality extended in connection with promotional, professional or scientific events shall be limited to travel, meals, accommodation and genuine registration fees.

Hospitality may only be extended to persons who qualify as participants in their own right.

All forms of hospitality offered to healthcare professionals shall be reasonable in level and strictly limited to the main purpose of the event. As a general rule, the hospitality provided must not exceed what healthcare professional recipients would normally be prepared to pay for themselves.

Hospitality shall not include sponsoring or organising entertainment (e.g., sporting or leisure) events. Members should avoid using venues that are renowned for their entertainment facilities.

Travel agenda and programme of events should be approved by the General Manager of the respective Member.

At least 60% of working hours* of an event (at the place without travelling time) should be dedicated to work.

Participation on the event should not be made dependent on request to prescribe determined amount of certain drug.

7.2
Where attendees are being sponsored to attend symposia, meetings are to be held in appropriate centres and geographically adequate locations. Funding must not be offered to compensate for the time spent by healthcare professionals in attending events.

7.3
The symposia´s focus should be on scientific and medical matters and hospitality should be secondary to the main purpose of the event.

EXPLANATORY NOTES

7.2
Appropriate centre is international standard generally accepted for medical audience. Adequate location is the Slovak Republic for Slovak audience in the case of events organised by the local company representation based in Slovakia (international or home producers). Location is not restricted in the cases of international events organised by international medical society and free standing company symposia with significant international participation.

8. RESEARCH

The following provisions shall relate to any financially rewarded research performed and/or sponsored by the pharmaceutical industry, with the exception of the clinical trial as defined and regulated by Sec. 15 - 18a of the Act No. 140/1998 Coll. on Drugs and Medical Aids as later amended, regardless of the fact whether it is performed by the manufacturer or by an organisation acting according to or on the basis of the manufacturer´s instructions.

Researches shall mean the following:
(a) non-interventional clinical trial as defined in Sec. 18a of the Act No. 140/1998 Coll. on Drugs and Medical Aids as later amended,
(b) other studies and researches, where data collection is not directly related to the prescription of a certain drug (e.g. epidemiological studies, marketing researches).

EXPLANATORY NOTES

Research sponsorship shall mean financial and other compensation provided in exchange for information.

8.1 Non-interventional clinical trial (NCT)

8.1.1.
The aim of NCT is to acquire scientific and professional information defined in NCT protocol.

8.1.2.
NCT is defined in Sec. 18a of Act No. 140/1998 Coll. on Drugs and Health Aids as later amended, which reads as follows:

Non-interventional clinical trial shall mean the monitoring of use of a registered drug in the course of health care providing. In non-interventional clinical trial:
a) the drug is prescribed in accordance with conditions stipulated in the decision on drug registration,
b) ranking of a patient into a given therapeutic strategy is not predetermined by a protocol, but it is based on common therapeutic practice,
c) decision of a physician on prescription of a drug is clearly detached from the decision to rank a patient into a clinical trial,
d) a supplementary diagnostic procedure or a monitoring procedure on a patient needs not to be used,
e) epidemiological methods are used to analyse the collected data.

8.1.3.
Each NCT must have a formal protocol containing the following information:

(a) Title,
(b) Objective/Objectives,
(c) Commencement date and completion date of data collection,
(d) Name of professional coordinator / supervisor,
(e) Study design,
(f) Data processing method,
(g) Form of notification of adverse effects,
(h) Expected date and form of publication of results,
(i) Bibliography references,
(j) Contact address.

Each NCT must have an own code on every page of the protocol and questionnaire for identification.

EXPLANATORY NOTES

8.1.3

a) Title
It should give a clear idea about the essence of NCT in one sentence.

b) Objective/objectives
Description of what NCT contractor is monitoring, where possible stating a hypothesis / hypotheses.

d) Name of professional coordinator / supervisor
Name of a professional - physician in the field in which NCT is performed. He/she should be the guarantee of a professional level of NCT. He/she must not be in a permanent labour relation with the NCT sponsor.

e) Study design
It should contain at least the following data:

• number of centres,
• number of patients,
• evaluation form (e. g. questionnaire).

f) Data processing method
Statistical methods planned to be used in evaluation of the collected data.

g) Form of notification of adverse effects
To whom and how the adverse effects are to be notified.

h) Expected date and form of publication of results
Publishing shall mean presentation of results to the professional public. The form may be a lecture, a poster or a publication in a professional periodical.

j) Contact address
At least the address of NCT contractor must be stated.

8.1.4.
The protocol must be handed over to each NCT solving team member upon commencement of his/her cooperation on NCT. In addition a written agreement or its electronic equivalent needs to be completed with each NCT solving team member outlining terms of cooperation and compensation.

8.1.5.
The distribution of drug samples must not be a part of NCT.

8.1.6.
The compensation of a solving team member for cooperation on NCT has to be in accordance with the work performed, it has to be a usual price, and it may not exceed the amount equalling to 1/10 of the minimum monthly wages* per hour.

EXPLANATORY NOTES

8.1.6

* In 2006, the minimum monthly wage amounts to SKK 7,600, where this amount will be appropriately valorised in subsequent years.

8.1.7.
The results of NCT must be published within 12 months from the completion of data collection.

8.1.8.
Medical Representatives are excluded from the following stages of NCT:

• formal compilation of the agreement (completion of the necessary forms, etc.),
• agreeing on a compensation for the cooperation,
• payment of any compensation.

Medical Representatives may in no event entice solving team members to recruit patients for NCT.

EXPLANATORY NOTES

8.1.8

• Medical Representatives must be informed before the trial commences how to report adverse events and who is the contact person for the adverse events reporting at the local company representation or at the headquarters.
• Medical Representatives should only deliver contract, which was already prepared by the contractor, and if it is signed by the medical professional, he/she should bring it back to the contractor.
• Medical Representatives shall distribute protocols, questionnaires and contracts and if the post is not used, they collect questionnaires.

8.1.9
Any NCT must be notified at the office of the Member home association before its implementation.

In the event there is submitted complaint, the Ethical Committee shall ask the office of the Member association for the complete trial documentation.

The compulsory notification must contain the following:

• the name and the goal of the trial,
• identification of the organisation or sponsor who organises and/or performs NCT,
• time schedule - expected commencement date and completion date of data collection,
• number of patients / centres involved,
• planned date and form of publication of results,
• the complete trial documentation and the protocol including approval of the competent Ethical Committee according to Sec. 2 par. 12 and Sec. 5 of the Act No. 576/2004 Coll. on Health Care, as later amended.

8.2 Other studies

8.2.1.
The objective of the other studies carried out and/or sponsored by the pharmaceutical industry (hereinafter referred to as the "other studies") may be, in addition to acquiring scientific and professional information, acquiring information for the contractor´s needs.

EXPLANATORY NOTES

8.2.1

Some examples of other studies:

• marketing researches to establish the position of a drug in relation to other drugs of the group,
• marketing researches to establish the quality of work of the contractor (Medical Representatives, marketing, etc.),
• marketing researches to establish the therapeutic habits of physicians,
• epidemiological researches to establish the occurrence of a certain disease.

8.2.2.
Offer for cooperation on other studies must not be connected with prescription of any drug.

8.2.3.
The compensation of a solving team member for cooperation on other studies has to be in accordance with the work performed, it has to be a usual price, and it may not exceed the amount equalling to 1/10 of the minimum monthly wages* per hour.

EXPLANATORY NOTES

8.2.3

* In 2006, the minimum monthly wage amounts to SKK 7,600, where this amount will be appropriately valorised in subsequent years.

8.2.4.

The Medical Representatives are excluded from the following stages of other studies:

• formal compilation of the agreement (completion of the necessary forms, etc.),
• agreeing on a compensation for the cooperation,
• payment of any compensation.

EXPLANATORY NOTES

• Medical Representatives should only deliver contract, which was already prepared by the contractor, and if it is signed by the medical professional, he/she should bring it back to the contractor.
• Medical representatives shall distribute protocols, questionnaires and contracts and if the post is not used, they collect questionnaires.

8.2.5
Each other study must be notified at the office of the Member home association before its implementation. In the event there is submitted complaint, the Ethical Committee shall ask the office of Member association for the complete study documentation.

The compulsory notification must contain the following:

• the name and the goal of the other study,
• identification of the organisation or sponsor who organises and/or performs the other study,
• time schedule - expected commencement date and completion date of data collection,
• in case it is planned to publish results - the planned date and form,
• in case it is not planned to publish results - the grounds for such a decision.

8.3

Any trial or study must be notified at SAFS, GENAS or ADL office based on the membership. The notifications shall be available for disclosure only to the delegated person of the office of the respective association, and to the members of the Ethical Committee of the Slovak Pharmaceutical Industry only if the claim is being heard by the Committee.

9. RELATIONS WITH HEALTHCARE PROFESSIONALS

Members may choose to support professional activities, by financial or other means. Such support must be able to successfully withstand public and professional scrutiny, and conform to professional standards of ethics and of good taste.

9.2 Medical Educational Material

9.2.1

Materials supplied for medical education must include the name of the manufacturer and its mailing address in the Slovak Republic.

9.2.2

Material supplied for medical education may include promotional claims and/or statements, however, in such an event must comply with Section 3 of this Code.

9.3 General Remuneration
Any remuneration for services rendered should not exceed that which is commensurate with the services supplied. The remuneration must not be dependent upon prescribing of a determined amount of certain product and no such condition shall be made or implied.

9.4 Gifts and Inducements
When drugs are promoted to healthcare professionals, no gift, pecuniary advantage or benefit in kind may be supplied, offered or promised to such healthcare professionals, unless such gift, advantage or benefit are of little value and irrelevant for the performance of medical or pharmaceutical practice.

The maximum amount representing little value that is allowed to be provided to one person annually shall be deemed the amount equalling to one third of minimum monthly wages.

EXPLANATORY NOTES

9.4

Social gifts that do not originate from promotion of drugs, e.g. in form of sweets or flours, shall not be considered gifts under Article 9.4.

10. PUBLIC AND MEDIA RELATIONS.

Information delivered to public has to be used exclusively for improvement of public knowledge from medical and healthcare area only. Such information about new chemical entities, new drugs and ways of treatment delivered to public and media has to be:

• truthful, verified, full, clear and understandable;
• would not contain any unproved assumptions and expectations;
• would not create an false illusion for patients about treatment efficacy or unverified hope for certain improvement of his health status;
• free of intention to cheat journalist or patient or intention to damage competitor.

No pressure has to be created to media professionals to publish delivered information. They have to have freedom for their own decision how they will use information according to their professional opinion and reader´s interests.

Media have to be not financially motivated by advertising or other barters to publish certain information about prescription drugs. In this case it is advertising which is prohibited by law.

10.1. No advice on personal medical matters
In the case of requests from individual members of the general public for advice on personal medical matters, the enquirer should be advised to consult a healthcare professional.

10.2. Press releases
Press release has to follow all rules stated under this Section. Content of press release has to use proved facts without advertising messages.

10.3. Press Conferences
Information delivered to journalists has to follow all rules stated under this Section. It is recommended to use as speakers for medical information, methods of treatment and drug related information preferably medical professionals which are not company employees. Hospitality or other hospitality have to be appropriate and in proportion to the occasion. The standard part of a press conference has to be the press release.

10.4. Radio and TV
Radio and TV broadcasts have to follow all rules stated under this Section.

10.5. Entertainment and incentives
Hospitality or other hospitality offered to journalists should be appropriate and in proportion to the occasion and must not motivate or oblige journalists to publish information delivered by company in wished manner.

The journalists would be invited by company for foreign trips or trips within Slovakia for educational or expert purpose only and hospitality should be secondary to the main purpose of the event.

This Code of Conduct of Pharmaceutical Industry in Slovakia is valid from 1 January 2008.

Bratislava, 18. December 2007

prof. MUDr. Pavel Švec, DrSc., v.r.
Chairman,
Pharmaceutical Industry Ethical Committee

• Annex GLOSSARY

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