APME Code

(Version III adopted on 9^th of December 2005)

 

 

The pharmaceutical industry respects high norms of ethics and their strict implementation and is convinced that internal regulation in marketing practices protects in the best way the common interests.

 

 

On international pharmaceutical manufacturers lies the responsibility to improve the health of the entire human society by researching and developing new and innovative medicines, manufacturing pharmaceuticals with reliable qualities, assuring that the best methods of production and ethics have been implemented.

It is in the best interests of the human society that pharmaceutical industry is obliged to give precise and correct information about their products to the healthcare administration to reassure the correct use of medicines.

Advertising and marketing activities must be in coherence with high norms of ethics and the information given by healthcare workers must be in the best interests and improve the treatment process of patients. Information given must be objective, true, ethical and in coherence with all legislation and articles. Product prescribing information must be based on reliable scientific data and include references to possible side-affects, contradictions and precautions.

High standards of ethics should be among the highest priorities in all countries with out any appellation to the stage of economic or healthcare development.

The code follows the European Union's and EFPIA's vision presented in the European code of promoting medicines sales.

 

Adopted in 1991 at the initiative of the European pharmaceutical industry, the code took effect on 1 January 1992. On 31 March 1992 the Council of the European Communities adopted Council Directive 92/28/EEC to govern the advertising of medicinal products for human use in European Community Member states. The revised version of the EFPIA Code took effect on 1 January 1993. The EFPIA code was further revised in 2004 to adopt various improvements and to make it fully consistent with the Directive 2001/83/EC, this version of the EFPIA code is also the base for the Code at hand.

The Code seeks to ensure that pharmaceutical companies conduct promotion in a truthful manner, avoiding deceptive practices and potential conflicts of interest with healthcare professionals, and that promotion is in compliance with applicable laws and regulations.

The code of practice on the promotion of medicines aims to define the general norms for marketing practices.

 

 

The code regulates all actions undertaken to promote the sales of medicines covering all informative and marketing activities that a pharmaceutical company or its representative uses to promote the prescription, supply, sale, administration or consumption of its medicinal product(s).

The code regulates the promotion of both: prescription medicines prescribed by doctors and other medicines meant for prescription or distribution by any affiliate body.

The code regulates all methods used in the promotion process which include written promotional activities and communications, journal, direct mail advertising, the activities of medical sales representatives, audio-visual materials (e.g. films, video recordings, data storage services and the like) and the provision of samples, gifts and hospitality. It aims to improve the quality of scientific and medicinal exchange of information during the research and marketing period.

 

Marketing authorisation

 

Section 1.01. A medicinal product must not be promoted prior to the grant of the marketing authorisation allowing its sale or supply outside of its approved indications.

The delegation of information must be based on scientific data.

The exchange of medicinal or scientific data during the research and development process is not denied when the information exchanged or other activities cannot be considered to be promotional.

Section 1.02. Promotion must be consistent with the particulars listed in the summary of product characteristics of the relevant medicinal product approved by the State Agency of Medicine

The presentation of increased medicinal productivity or the results of clinical research is allowed. Scientific works and abstracts are allowed for presenting only when in original form. The effects that are not listed in the summary of product characteristics may not be promoted.

 

Information to be made available

 

Section 2.01. Subject to applicable national laws and regulations, all promotional material must include the following information clearly and legibly:

a)      Essential information consistent with the summary of product characteristics, specifying the date on which such information was generated or last revised.

b)      The supply classification of the product.

Section 2.02. The name of the trademark, medicinal product or its international non-proprietary name cannot be used in advertisement as a reminder in Estonia.

 

Information and its substantiation

 

Section 3.01. Information

A)    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.

B)     It must not mislead by distortion, exaggeration, and undue emphasis, omission or in any other way.

C)    The word 'safe' must never be used to describe a medicinal product with out proper qualification.

D)    It cannot be suggested that a medicine does not have side effects, toxic and addiction hazards.

E)     Scientific data, when referred to, must be reproduced exactly and also a source should be given.

F)     The word 'new' should not be applied to a product has been on the market longer than a year.

G)    Any comparison made between different medicinal products must be based on relevant and comparable aspects of the products. Comparative advertising must not be misleading or disparaging.

Section 3.02.Use of interpretation and quotations

A)    All information in promotional materials must be illustrated with sources on the request from doctors or other healthcare workers.

B)     Quotations from medicinal or scientific literature must be presented with out any distortion, modifications and in case the information has been distorted or modified, the source must be referred to.

 

Acceptability of promotion

 

Section 4.01. Promotional materials and activities must recognise the professional reputation of the auditory to which promotion is directed and not insult its integrity.

Section 4.02. The medicines, products and activities of other pharmaceutical companies must not be undermined.

Section 4.03. The clinical and scientific knowledge of healthcare employees and workers should not be undermined.

Section 4.04. Companies must follow high ethical standards in their conduct. A presentation should not discredit, reduce reliability nor undermine the reputation of the pharmaceutical industry.

 

Distribution of promotion

 

Section 5.01. Promotion should only be directed at those whose need or interest in the particular information can reasonably be assumed.

Section 5.02. Mailing lists must be kept up-to-date. Requests by healthcare professionals to be removed from promotional mailing lists must be complied with.

Section 5.03. The use of faxes, e-mails, automated calling systems, text messages and other electronic data communications for promotion is prohibited except with the prior permission, or upon the request, of the recipient.

 

Transparency of promotion

 

Section 6.01. Promotion must not be disguised.

Section 6.02. Clinical assessments, post-marketing surveillance and experience programmes and post-authorization studies must not be disguised promotion. Such assessments, programmes and studies must be conducted with a primarily scientific or educational purpose.

Market research and analyses should be conducted by an impartial party to ensure that the results are not used for boosting the sales for any pharmaceutical company. The statistics and information from market research may be used for marketing. The two stages must be kept separate from each other.

Section 6.03. When a pharmaceutical company publishes its promotional materials in newspapers or journals then the purpose of the advert must be clear and distinguishable from other independent materials.

Section 6.04. The name of the pharmaceutical company must be clearly distinguishable on promotional materials sponsored.

 

No advice on personal medical matters

 

Section 7.01. In 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.

 

Gifts

 

Section 8.01. Gifts, pecuniary advantages and benefits must be in accordance with the legislation. Gifts must be related to medicinal activities and may not be used as an inducement to prescribe, supply or administer a medicinal product.

Section 8.02. Monetary gifts and the disregard to the 100 EEK value border (further on referred to as sponsoring) is allowed only in case of sponsoring the participation of an individual at an event with medical or pharmaceutical content which is organised by a scientific institution or a medical organisation. This kind of sponsorship is only allowed under conditions that are made public prior to the occasion and do not include the sale or prescription of any pharmaceutical manufacturer's medicine; all sides must enter into a contract that excludes the influence to the sales and prescription of any drug.

Section 8.03. Healthcare workers must be uninfluenced from monetary gifts.

Section 8.04. The marketing authorization holder  is prohibited to offer (and the retailers, associations of retailers and their employees may not accept) monetary and non-monetary gifts that would affect the sales of a medicine. The recommendations made at a pharmacy must be based on medical and scientific criteria.

Section 8.05. MA holder is not allowed to organize lotteries and drawings targeted to people with authorisation to prescribe medicines and pharmacists.

Section 8.06. Gifts for the personal benefit of healthcare professionals should not be offered or provided.

 

Events and hospitality

 

Section 9.01.   All promotional, scientific or professional meetings, congresses, conferences, symposia, and other similar events organized or sponsored by a company must be held in an appropriate venue that is conducive to the main purpose of the event which is strictly of educational content.

Delegate must be drawn to the scientific program not the secondary hospitality.

All expenses made cannot exceed the level where receiver of the hospitality would cover the same expenses made under the same conditions given.

Section 9.02. Hospitality must be secondary nature.

Section 9.03. Hospitality must not be extended to accompanying persons.

Section 9.04. The sponsorship by a pharmaceutical company must be showed in all documents relating to the event and all publications. The declaration of sponsorship must be visible to all readers to ensure the public's awareness.

Section 9.05. Hospitality in connection with promotional, professional or scientific events shall be limited to travel, meals, accommodation and genuine registration fees. Registration fees should not include entertainment like city excursions, gala meals or other.

Section 9.06. The organising of sporting and entertainment events is strictly prohibited. Companies should avoid using venues that are renowned for their entertainment facilities.

Presumption to the organising of an event is the existence of suitable conference and meeting halls.

Section 9.07. No company may organize or sponsor an event that takes place outside Estonia unless:

1)      The majority of the participants come from outside Estonia and it is logistically the most beneficial to hold the event in another country.

2)      Taken into account that necessary infrastructure or that the location of the know-how, what is the subject or the object of the event, is located outside of Estonia therefore it is logistically best to organize the event in another country.

 

Sponsorship of Healthcare Professionals

 

Section 10.01. The marketing authorization holder has the right to sponsor the attendance of individuals at medical or scientific events, covering the participation fee for the scientific event, travelling costs and accommodation fees to a reasonable extent. Sponsorships can only be targeted to healthcare professionals.

 

Relations with the public and media

 

Section 11.01. Public promotion containing prescription drugs, homeopathic preparations and oral anti-pregnancy pills is prohibited. This restriction does not apply to vaccination campaigns coordinated with the State Agency of Medicine.

Section 11.02. Promotion directed to the public may not include references to the treatment of tuberculosis, venereal diseases or some other severe contagious disease, cancer, chronic insomnia, diabetes or other metabolic diseases.

Section 11.03. Promotion must be in accordance with medicines Act §83 requirements:

1)      Must be clearly distinguishable from other text and its message must be unambiguously understandable as product promotion.

2)      Must be up-to-date, comprehensible, ensure its distinction from other medicines and include enough information for the right and safe utilization.

3)      Include the text 'Caution! Medicines must be handled with care. Before use read the patient information leaflet. With further complaints address a doctor or a pharmacist.'

Section 11.04. Companies are responsible for the information what their public relations office hands out.

 

Employees of pharmaceutical companies

 

Sales representatives

Section 12.01.01. Each company shall ensure that its sales representatives, contracted sales forces, and any other company representative who call on healthcare professionals, pharmacies, hospitals or other healthcare facilities in connection with the promotion of medicinal products are adequately trained and have sufficient scientific knowledge to be able to provide precise and complete information about the medicinal products they promote.

Section 12.01.02. Medical sales representatives must approach their duties responsibly and ethically.

Section 12.01.03. Sales representatives must follow the requirements stated in the codes and in the Estonian legislation.

Section 12.01.04. During each visit medical sales representatives must give the persons visited, or have available for them, a summary of the product characteristics for each medicinal product they present.

Section 12.01.05. Medical sales representatives must transmit to the scientific service of their companies forthwith any information they receive in relation to the use of their company's medicinal products, particularly reports of side effects.

Section 12.01.06. Medical sales representatives must not use any inducement or subterfuge to gain an interview.  In an interview, or when seeking an appointment for an interview, medical sales 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.

 

Section 12.01.07. Medical sales representatives must ensure that the frequency, timing and duration of visits to healthcare professionals, pharmacies, hospitals or other healthcare facilities, together with the manner in which they are made, do not cause inconvenience.

 

Employees of pharmaceutical companies

 

Section 12.02.01. Managing director of the company is responsible for implementation and compliance with the code.

Section 12.02.02. All company staff, and any personnel retained by way of contract with third parties, who are concerned with the preparation or approval of promotional material or activities must be fully conversant with the requirements of the applicable code(s) and relevant laws and regulations.

Section 12.02.03. 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 or she has examined the final form of the promotional material and that in his or her belief it is in accordance with the requirements of the applicable code(s) and any applicable advertising laws and regulations, is consistent with the summary of product characteristics and is a fair and truthful presentation of the facts about the medicine.

 

Samples

 

Section 13.01. A limited number of free samples of medicinal products may be supplied to healthcare professionals who are qualified to prescribe medicines.

Section 13.02. Samples may be given only in response to a written request, signed and dated, from the recipient.

Section 13.03. Total number of samples handed out during a year must not exceed 300 and not more than 5 samples per person of the smallest registered pack variant.

Section 13.04. Each sample must be marked 'Not for sale' and must be accompanied with a copy of SPC. Samples may not be sold or passed on with non-medicinal purposes.

Section 13.05. Samples handed out by sales representatives must be directly given to healthcare professionals who have presented a written request.

Section 13.06. Handling of samples in a hospital must abide with the requirements in particular hospital.

Section 13.07. The marking authorization holder must have a precise control and tracking system with up-to-date information on all samples and medicines handed out by sales representatives.

Section 13.08. Restrictions on sample distribution are stated in Medicines Act.

 

The implementation of the Code

 

Section 14.01. Filing a complaint

Every medical employee, company or a representative of the public may present a complaint to the Ethics committee provided that the complaint was made good faith and it is guided by the principles and goals of the code.

When a complaint reaches the Ethics Committee on the matter of a violation according to the APME code then it should be decided whether:

 

Complaints must be filed in written form and they must include the following information:

1)      Name of the proposing party:

Personal information, exact postal information and fax number.

2)       The Name of the violator of the code:

Company's name and its product's name.

3)      Reference material:

In every case the promotional material or a description of the violation must be presented in writing as evidence to be investigated.

4)      The date:

The date of the violation.

5)      Content of the violation:

For every case a short description of the violation with a reference to the point violated in the code must be given.

All complaints must be mailed to address:

 

APME's contact Helve Remmel

Roosikrantsi 10A

Tallinn

e-mail: helve.remmel@rrle.ee

 

 

Section 14.02. Order of handling the complaint

The APME committee consists of 6 members. The ethics committee must take notice of the violation of orderly marketing traditions both inside and outside APME.

 

When the complaint is directed towards a company participating in the ethics committee then that company cannot take part in the discussions and workgroups involving the complaint.

 

One complaint may include several cases meaning references to different companies and/or products' promotion. Every reference will be considered as a separate case.

In every case the first step is to define the company, locate its headquarters in Estonia, its international headquarters and its address.

 

To the Estonian office (when a local office does not exist, to the international headquarters) a summary of every case presented in the complaint will be forwarded with evidence material (for instance a copy of the promotional material used).

When the case involves a company that does not belong to APME by a local representation or holding company then the case is still viewed as similar to those of the companies that belong to the organisations.

When necessary the violation may be reported to the holding company, State Agency of Medicines and EFPIA.

In case of more complex and severe complaints the APME committee will decide upon what actions to take, how to publicise the information and what institutions to report the complaint.

 

Section 14.03. Evaluating deadlines for complaints

APME contacts will forward the complaint immediately to the committee.

 

Ethics committee will review and reply to complaints at first opportunity but not later than 30 days after the complaint has reached the committee. Company's answer to the complaint must arrive within 30 days from receiving the complaint documents.

As an exception deadlines can be extended. This case may occur when the complaint is handled in accordance to Estonia's legislation where different timeframes apply. In that case the proposing party will be informed of the extension and the reasons of the extension.

 

Section 14.04. Reaction on the complaint

When a company admits the fact that it has breached the code then it has to present a plan of activities or a list of activities undertaken to compensate the situation.

 

In case the company refuses to admit its violation then it has to present a clear justification and evidence that would explain the company's side. The company's answer will be used in preparation of the APME committee decision.

The APME committee will make its decision on the complaint within 30 days after the answer from the company has arrived and both the party who made the complaint and the company will receive a written copy of the decision.

Ethics committee will decide upon the notification of EFPIA and State Agency of Medicines.

 

Section 14.05. Publication of the results

When a decision on the complaint has been reached and the complaint has been satisfied then the information on the matter will immediately be posted on APME homepage, bringing out the names of the both parties.

Also information will be published when the company has not answered in the timeframe given.

APME committee will assess the extent of the violation and the consequences, which will result in the further handling of the case.

The committee will also decide whether it is necessary to inform the holding company, State Agency of Medicines, EFPIA and the public through media channels.

 

Section 14.06. Overviews

 

An overview of the implementation of the APME code and the summary of all complaints handed in will be published on the demand of the ethics committee. It will be distributed on necessity to the officials of the Ministry of Social Affairs, State Agency of Medicines, WHO and leading medicinal journals.

In the information the names of the companies, characteristics of the violation and products concerned are brought out.

Also cases that have not been satisfied will be brought out alongside with cases that the code does not apply to (e.g. companies that do not belong to APME).

 

An overview of the rejected complaints is given where the case has been unsatisfied and there company names or product names are not mentioned.

A brief statistics is published that reflects the nature of the cases and the results of the investigations.

 

Section 14.07. Comments on the procedure of handling complaints

 

A case in which a violation of the code has been noted is not considered 'closed' until the company has acknowledged the violation and has started to compensate the damage done.

When a complaint questions the scientific basis of the promotion, the company must present data and scientific information to ensure the correct discussion on the matter or admit that it has broken the code. In the implementation of the code and in the evaluation process of the complaints national legislation must be taken into an account.

 

Section 14.08. Broadening the affects of the code

 

The order according to which complaints are investigated helps to create a mechanism to review violations after they have occurred. The APME code promotes the conformity of abiding with ethical norms and control over correct conduct to reduce the breaches leading to the disturbance of the code.

 

EFPIA code is taken into an account in the codes of national member associations and in the proceedings in the inter-company networks. The EFPIA code is fitted with the local legislation.

 

To enhance the obedience and discipline towards the code, an office of EFPIA is authorised to:

1)      Gather and distribute information relating to the promotional practices of member associations including the validation, strengthening and abiding with national acts and to give the pharmaceutical companies an incentive to abide with EFPIA/ APME codes.

2)      Give member associations advice and recommendations for validating local codes and acts, strengthening and following them; based on the experience from the implementation of EFPIA code

3)      Develop contacts and hold meetings with other interested organisations for the purpose of arranging a forum on the topic of medicines' promotion and marketing practices.