Code of Ethics for promotion practices of pharmaceutical industry and interaction with health professionals

Professional conduct’s issues should be, and have been, throughout the years a real concern for the Portuguese Pharmaceutical Industry.

Since 1987 APIFARMA is governed by Codes of Ethics which, as time goes by, have gone under changes as a result of the changes with national and community legislation and the ongoing need to clarify concepts and practices.

On the other hand, various versions of Code of Ethics were influenced also by the Code of Ethics of IFPMA (International Federation of Pharmaceutical Manufacturers and Associations) and EFPIA (European Federation of Pharmaceutical Industries and Associations) of which our association is a member.

This version merges in a single body the previous version of the Code and the recent EFPIA Code of Ethics approved in October 2007, integrating the aspects regarding advertising of medicinal products in compliance with Decree-Law no. 176/2006, of 30 August.

This Code of Ethics governs, for the first time, the relations of Patients Organizations with the Pharmaceutical Industry, referring this subject to Code of Conduct for the relations between Pharmaceutical Industry and Patients Organizations.

Emerging from the approval of the community code (Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001) and aiming at improving and make the self-regulation system more efficient, principles and standards of internal conduct, resulting from the ongoing need to make proceedings become swifter, were sanctioned in line with similar European Associations.

APIFARMA Code of Ethics does not aim at restraining the promotion of medicinal products in such a way as to hinder free competition, seeking rather to ensure that member pharmaceutical companies engage in an ethical promotion, restraining from deceitful practices and potential conflicts of interest with health professionals, whilst complying with applicable laws and regulations for the benefit of the name and prestige of the Pharmaceutical Industry.

Therefore, the purpose of APIFARMA Code of Ethics is to enable an environment where the general public may be sure that the choices regarding their medicinal products are made based on the merit of each product and the patients’ clinical needs.

The rules sanctioned here were freely discussed and voluntarily accepted, and are binding for all APIFARMA members.

Article 1

Scope

1. This Code of Ethics aims at establishing a set of standards which represent the application to the promotion and marketing practices of medicinal products and the interaction with health professionals of a suitable ethical level for this activity, by means of which independence and transparency criteria are to be safeguarded, respecting the patients’ health and life, health professionals’ integrity and the image and capacity of the Pharmaceutical Industry.

2. This Code should be complied with notwithstanding the integral respect of the applicable legal and regulatory provisions, which from an ethics point of view should also be fully complied with.

3. This Code does not apply to:

a) labelling of medicinal products and package leaflets, which are subject to the applicable legal provisions;

b) correspondence, possibly accompanied by non promotional material, required to answer to a specific question on a specific medicinal product;

c) evidence-based informative advertisements and reference materials regarding, for instance, changes in package, warnings as to adverse reactions as part of general precautions, commercial catalogues and price lists provided they do not include messages regarding attributes or properties of the products;

d) non promotional information regarding human health or diseases;

e) the companies’ institutional advertising, such as financial data, description of research and development programs and the analysis of normative developments affecting the society and its products.

Article 2

Marketing authorization

1. A medicinal product can only be promoted for the respective approved indications, after it has been granted a marketing authorization which enables its sale or dispense.

2. The promotion should comply with the elements identified in the summary of medicinal product characteristics.

3. The right of pharmaceutical companies to inform the scientific community about the advances in the field of Medicinal products and Therapies is excluded from no. 1 and those companies may disclose the results of Scientific Research they are carrying out for that purpose.

Article 3

Information that should be made available

1. All promotional materials regarding prescription only medicinal products should include in a clear and legible manner the following:

a) the name of the medicinal product;

b) duly referenced information, according to the summary of medicinal product characteristics, indicating the date when it was prepared or reviewed for the last time;

c) the classification of the medicinal product according to the dispensing system;

d) the contribution system;

e) date when they were last prepared or reviewed.

2. Information included in the documentation has to be accurate, current, checkable and sufficiently complete to enable the user to have a correct idea about the therapeutic value of the medicinal product.

3. When the information aims exclusively at bringing the attention to the medicinal product’s name, the indications provided for in no. 1 are excused.

Article 4

Promotion and its substantiation

1. The information on the characteristics of the medicinal products should not exceed the limits guaranteed by available scientific proof and it must be prepared free of ambiguity.

2. The information included in promotional material or the one intended for the suitable use of the medicinal product should:

a) be grounded on an updated evaluation of all available scientific proof and according to the provisions of the summary of the medicinal product characteristics;

b) be in accordance with the marketing authorization; and

c) do not rise any incorrect or wrong conclusions.

3. Scientific data supporting statements on the medicinal product characteristics should be made available to health care providers when they request them.

4. Information on side-effects should reflect the available proof and be likely to be substantiated through clinical experience. Companies don’t have to provide substantiation regarding the validity of the elements approved in the summary of the medicinal product characteristics.

5. Promotion should encourage the rational use of medicinal products, presenting them in an objective manner without overstating their properties.

6. All promotional elements, including charts, pictures and tables of studies published and integrated in promotional materials should:

a) clearly indicate the exact source or sources of the promotional elements;

b) be faithfully reproduced. In case of need they may be adjusted, mentioning the introduced adjustment.

Article 5

General Promotion

1. The word “safe” should never be used to classify a medicinal product.

2. The word “new” should neither be used to classify a medicinal product or any presentation which has been available for more than one year, nor a therapeutic indication promoted or launched more than one year ago.

3. No medicinal product should be presented mentioning that it has no side-effects, toxicity, addiction or dependency risks.

Article 6

Comparative advertising

1. Comparative advertising is only permitted among health professionals.

2. Comparisons among different medicinal products should be based on relevant and comparative aspects of the former and should neither be deceitful nor defamatory.

3. Comparisons among different medicinal products can only be made based on the elements included in the respective summary of the medicinal products characteristics or on credible clinical data.

Article 7

Use of quoting in promotion

Quoting of medical or scientific literature should be faithfully reproduced and dully referenced.

Article 8

Acceptability of promotion

Promotion should be adjusted to the receiver and carried out according to suitable ethical levels, so that the social value of the medicinal product can result from it and the latter’s special nature can be acknowledged.

Article 9

Dissemination of promotion

1. Information regarding prescription only medicinal products should only addressed to people which, within reason, may be assumed as to be in need or have interest on that information.

2. The use of faxes, email, automatic call systems, text messages and other means of electronic communication are allowed only with the previous authorization or request of the health professional.

3. The lists to send correspondence have to be always updated, and should be prepared according to national law in force. The health professionals’ requests to be removed from lists of promotional mails should be respected.

Article 10

Transparency of promotion

1. Promotion should not be deceitful, subliminal or concealed.

2. The studies or programs on the use of medicinal products, such as pharmacovigilance programs, post-marketing experiences and post-authorization studies, may not be used as a disguised way for medicinal products’ promotion and should be carried out for scientific or educational purposes.

3. Promotional materials published in newspapers or magazines, on the initiative of a company, should not be similar to independent editorial articles, and should be clearly identified as being of advertising nature.

4. Materials regarding medicinal products and their uses, whether of promotional nature or not, which are sponsored by a company should clearly indicate the name of the sponsoring entity.

Article 11

Promotion on the internet

1. Internet promotion of medicinal products targeting health professionals should be based on technical, scientific and professional principles.

2. Companies should adopt such measures so as to guarantee that the promotion is accessed only by health professionals.

Article 12

Interdiction of advice on personal medical matters

1. Companies which are the holders of marketing authorizations or promoters of medicinal products cannot respond to general public requests for advice on personal medical matters, and should refer these requests to a health professional.

2. Companies should guarantee the confidentiality on possibly conveyed clinical data.

Article 13

Events and hospitality

1. All meetings, congresses, conferences, symposiums and other events of a promotional, scientific or professional nature (“event”), organized or sponsored by a company which is the holder of a marketing authorization or promoter of a medicinal product have to take place in a suitable venue regarding the main purpose of the event, and can only provide suitable hospitality and should comply with all legal provisions in force.

2. No company can organize or sponsor events outside their home country (“international event”), unless:

a) the majority of the participants are foreigners and taking into account the home countries of most of the guests it is more reasonable, in logistic terms, to carry out the event in another country; or

b) taking into account the location of the resources or relevant knowledge which are the object or topic of the event, it is more reasonable, in logistic terms, to carry out the event in another country.

3. Hospitality provided for promotional, professional or scientific events, should be limited to travel, meals, accommodation and registration costs; however social aspects that may complementary exist cannot coincide with any work meeting.

4. Hospitality should not exceed the period between the day prior to the beginning of the event and the day after the end of it, and can only be provided to health professionals who attend the event on their own right.

5. Hospitality provided to health professionals should be of a reasonable level and be strictly limited to the main purpose of the event. As a general rule, hospitality provided should not exceed what health professionals attending the event would be willing to pay for themselves.

6. Hospitality cannot include the sponsorship or the organization of events of an entertainment nature (v.g. sports or leisure events), and the companies should restrain from choosing venues/undertakings known for their entertainment facilities.

Article 14

Sponsoring scientific events

1. Whenever a company sponsors a symposium, congress or any other health, medical or educational program, it should take into consideration the following principles:

1.1. The sponsorship should be clearly advertised prior to the identified event, during it and after the event has been held. All and any printed, audiovisual or computer based information material which may result from such meetings, should reflect correctly the presentations and discussions;

1.2. The support to the attendance of health professionals should not be conditioned by the obligation of promoting any medicinal product.

1.3. If the program is recognised for the purposes of post degree professional training, by a recognised medical organization or any other equally recognised health professionals’ organization, the support of the Pharmaceutical industry, if any, should be disclosed.

1.4. The payment of fees and the reimbursement of expenses, including those resulting from travel, to speakers and moderators of the event is considered to be suitable.

2. Financing should not be provided as a way of compensation for the time spent by health professionals with attending those events. In the case of international events for which the company sponsors the attendance of a health professional, financing is subject to legal and ethical rules pertaining to the place where the health professional carries out his/her practice, and not the ones which are in force in the place where the international event takes place.

Article 15

Gifts and Incentives

1. No gifts, cash benefits or benefits in kind can be given, offered or promised to health professionals, which in some direct or indirect way, encourage them to prescribe, dispense, sell or give a medicinal product.

2. Notwithstanding the provisions of the previous number, in cases when medicinal products are promoted among health professionals, benefits in kind may be given or offered to these people only if those benefits have a low cash value and are relevant for the practice of medicine or pharmacy and/or involve a benefit for the patient.

3. Gifts may only include the company’s name and logo, the name of the medicinal product and/or its international non-proprietary name, if it exists, or trade mark. If gifts are aimed at providing additional information on the medicinal product this information has always to be compliant with the provisions of article 3 no. 1.

4. Gifts for the health professionals’ personal benefit, such as tickets for entertainment events, should never be given.

5. For the purposes of the provisions of this article, low cash value should be understood as a value not exceeding twenty five Euros.

Article 16

 Samples

1. Following a request in writing, dated and signed by a health professional that is qualified to prescribe, a reasonable number of samples may be provided to the former, in order to make him familiar with the product, during a period and in a quantity provided for in the law.

2. Companies should have control and counting systems in place for all the samples they dispense regarding all medicinal products handled by their representatives.

3. Samples cannot be greater than the smallest marketed presentation.

4. Samples should display the indication of “free medical sample – not for sale” or words with the same purpose and should be accompanied with a copy of the summary of the medicinal product characteristics.

5. No samples of the following medicinal products should be provided: a) medicinal products containing such substances defined as psychotropic or narcotic substances by an international convention, such as the United Nations Convention of 1961 and 1971; and b) other medicinal products for which the supply of samples is not deemed to be suitable, according to what competent authorities may establish at each moment.

                                                                                                  Article 17

Donations and subsidies to support health care provision or research

1. Donations and subsidies and benefits in kind granted to institutions, organizations or associations of health professionals and/or professionals providing health care or engaged in research are authorised if:

 a) they are made with the purpose to support health care provision or research;

b) they are documented and recorded by the donor;

c) they do not constitute an incentive to the recommendation, prescription, purchase, supply, sale or administration of certain medicinal products.

2. No donations or subsidies should be granted to health professionals individually.

3. Companies should disclose to the general public information on donations, subsidies or benefits in kind granted under this article.

Article 18

Contracts between companies and institutions

1. Contracts, not included in the previous number, between companies and institutions, organizations or associations of health professionals under which these institutions provide any kind of services to the companies are authorised if:

a) they are provided with the purpose of supporting health care provision or research;

 b) they do not represent an incentive to the recommendation, prescription, purchase, supply, sale or administration of certain medicinal products.

Article 19

Consultants

1. Pharmaceutical companies are allowed to hire health professionals as consultants and counsellors to participate, among others, in lectures, meetings, take part in medical/scientific studies, clinical trials, training programs, follow up of counselling and market research committees.

2. The participation of consultants is rewarded.

3. In situations provided for in no. 1 a written contract or agreement between the parties should be signed, before starting to provide the services, which should comply with the following criteria:

3.1. to specify the nature of the contract or agreement and the terms of payment of the provided services;

3.2. to identify in a clear manner, before starting the negotiations with potential consultants, the legitimate need for the services.

4. The criteria to select the consultants should be directly related with the need identified in the previous number, and the people in charge of their selection should have the required experience and knowledge to evaluate if the mentioned health professionals meet the established criteria.

5. The number of selected health professionals should not exceed the reasonable number of professionals required to achieve the identified purpose.

6. The contractor should keep all records related to the services provided by the consultants and use that information in a suitable manner.

7. The recruitment of a health professional as a consultant should not result, as a compensation, in an incentive to recommend, prescribe, purchase, supply, sell or administrate a specific medicinal product.

8. The compensation for services should be reasonable and reflect the market practice in a fair manner. No symbolic consultancy agreements should be used to justify the health professionals’ compensation.

9. The obligation of the health professional to identify himself/herself as the company’s consultant, whenever he/she writes or lectures in public on subjects which are the object of the contract or agreement, or even on any subjects related to the company should be included in any contract or agreement signed between the company and the health professionals, both in the scope of this article or the scope of an employment relationship.

10. In case a health professional is attending a national or international event as a consultant, the suitable provisions included in article 13 are applicable.

11. Limited market studies, such as phone interviews or questionnaires sent by mail /e-mail/internet, are excluded from the scope of this article provided the health professional is not consulted in a recurrent manner and the remuneration for the service is suitable and not excessive.

                                                                                          Article 20

Non-interventional studies of marketed medicinal products

1. A non-interventional study of a marketed medicinal product is defined as a study where the medicinal product(s) is (are) prescribed in an usual manner according to the provisions of the market authorization. The indication of a patient for a specific therapeutic option is not previously decided by means of an evaluation with a clinical trial protocol, but by the current clinical practice and the prescription of the medicinal product is clearly separated from the decision to include the patient in the study. No diagnosis or additional monitoring procedures should be used on the patients and epidemiological methods should be used for the analysis of the collected data.

2. Non-interventional studies involving the collection of patients’ data through, or on behalf of, a health professional, or a group of them, should comply with the following criteria:

2.1. The study must be carried out under a scientific objective;

2.2. A written plan to develop the study must be drawn;

2.3. A written contract must be signed between health professionals and/or institutes where the study is being developed and the sponsoring company, in which the nature of the services to be provided and the reasons for those services to be paid should be specified;

2.4. The payment to be granted should be reasonable and reflect the market value of the carried out work;

2.5. If there is an ethical commission in the institution where the study is being developed, the administrative board of that institution should be asked to give its opinion on the need to consult the mentioned commission;

2.6. The companies should comply with legislation on personal data protection;

2.7. The study should not constitute an incentive for the recommendation or prescription of a specific medicinal product;

2.8. The protocol of the study should be approved by the scientific service of the company and should be supervised by that service;

2.9. The results of the study should be analysed by the contractor, or on its behalf, and the summaries resulting from the study should be made available to the company’s scientific services as soon as possible;

2.10. The company’s scientific services should keep the records of the reports for a reasonable period of time;

2.11. The company should send the executive summary to the health professionals who have participated in the study and should make it available to the self-regulatory bodies of the pharmaceutical industry, if so required. In case the study reveals important results for the risk-benefit assessment, the executive summary should be immediately sent to the competent authority;

2.12. Medical sales representatives may only be involved in administrative issues and their involvement should be kept under the supervision of the company’s scientific service, which should also ensure the suitable training of the former. This involvement should not be associated with the promotion of any medicinal product.

3. Whenever applicable, companies are encouraged to comply with the provisions of no. 2 for all other sorts of studies covered by this article, including epidemiological studies and recording and other studies of a retrospective nature.

Article 21

Medical Sales Representatives

1. Each company should guarantee that its medical sales representatives, including personnel employed under a third party contract and other representatives of the company who visit health professionals, pharmacies, hospitals or other health facilities in connection with the promotion of medicinal products (individually a “medical sales representative”) are familiar with the requirements of the Code of Ethics and all applicable provisions.

2. Medical sales representatives should be duly trained by companies and have enough scientific knowledge to be able to provide precise and complete information on the medicinal products they promote.

3. Medical sales representatives should comply with all the principles of the Code of Ethics and all applicable provisions, and companies are responsible for their compliance.

4. Medical sales representatives should stand up to their duties with a sense of responsibility and ethics.

5. During each visit and according to the provisions of the applicable laws and regulations, medical sales representatives should provide health professionals with a summary of the medicinal products characteristics, or have it available for use.

6. Medical sales representatives should immediately convey to their company’s scientific departments, any information they get on the use of the medicinal products they promote, especially regarding adverse events.

7. Medical sales representatives should ensure that the frequency, scheduling and duration of the visits to health professionals, pharmacies, hospitals or other health facilities, as well as the way they are conducted, are in accordance with the ethics, the Code of Ethics and all applicable standards.

8. Medical sales representatives should not turn to incentives or expedients to arrange for an interview. During an interview or at the time of arranging for one, medical sales representatives should ensure they do not lead health professionals of health institutions into error as to their identity or the identity of the company they represent.

Article 22

Pharmaceutical company staff

1. All company’s staff and personnel employed under third party contracts, related to the preparation or approval of promotional materials or activities should be familiar with the requirements of the Code of Ethics and all other applicable standards.

2. Each company should have a scientific department in charge of handling the information of its medicinal products. This scientific department has to include a doctor or a pharmacist, who will be responsible for the approval of all promotional materials before their distribution.

3. Professionals mentioned in the previous number have to state that:

a) they have examined the promotional material in their final form and which they deem to be in compliance with the requirements of the Code of Ethics and all other standards in force including those of advertising;

b) are in compliance with the summary of the medicinal product characteristics; and

c) constitute a true and fair presentation of the facts on the medicinal product.

4. The company’s scientific department is also responsible for the supervision of all non-interventional studies, including all reviews related to those studies, namely as far as the responsibilities undertook by the medical sales representatives are concerned. The scientific department should make sure the protocol of the non-interventional study is examined and state that it complies with all the requirements provided for in this Code.

5. Each company should appoint, at least, one senior employee, who should be responsible for the supervision of the company and its subsidiaries, so as to ensure that the Code of Ethics and all the other provisions are complied with.

Article 23

Relations between the Pharmaceutical Industry and Patient Organizations

Companies should comply with the provisions of Code of conduct for the relations between the Pharmaceutical Industry and Patient Organizations.

Article 24
Offences against the Code and sanctions

1. The implementation of the provisions of this Code should be supervised by the Council of Ethics of APIFARMA.

2. In the case a violation of the provisions of this Code is detected, the claim shall be sent to the Council of Ethics, following the steps in the proceedings provided for in the Regulation of the Council of Ethics.

3. In the case of a violation of the provisions of the Code, the Association should ask the offender to immediately put an end to the irregular activity and to undertake, in writing, the obligation to not relapse in that practice.

4. The violation of the provisions of this Code by a company is considered as a disciplinary offence, and the applicable sanctions are provided for in APIFARMA Statutes.

5. The sanction applied, as well as the nature of the offence, shall be published by APIFARMA.

Version approved in Special Session of General Assembly of 28 May 2008

This Code of Ethics shall come into force on 1 July 2008

 Code of Ethics in pdf