Code of conduct of innovative pharmaceutical companies in relationships with patient organisations

/Code of conduct of innovative pharmaceutical companies in relationships with patient organisations
Code of conduct of innovative pharmaceutical companies in relationships with patient organisations 2017-09-10T01:24:01+00:00

Pursuant to Article 16 of the Statute, General Assembly of the Innovative Pharmaceutical Initiative on its session held on 30 June 2014 in Zagreb adopted the following

Code of conduct of innovative pharmaceutical companies in relationships with patient organisations

Pharmaceutical companies being members of the association Innovative Pharmaceutical Initiative
(hereinafter: the Association) is the representative body of research-oriented manufacturers of
medicinal products that are duly organised and act in the Republic of Croatia in line with applicable
legislation, recognise the fact of existence of common interests between pharmaceutical industry
and patient organisations in the area of health and social care.
By adoption of this Code the Association wishes to ensure that cooperation between patient
organisations in the area of health and social care takes place in an ethical and transparent manner
with full commitments to the following principles:
1) the independence of patient organisations in terms of their political judgement, policies and
activities shall be assured.
2) all partnerships between patient organisations and the pharmaceutical industry shall be based
on mutual respect with the views and decisions of each partner having equal value.
3) the promotion of a particular prescription-only medicine shall not be requested or undertaken.
4) the objective and scope of any partnership shall be transparent. Financial and non-financial
support provided by the pharmaceutical industry shall always be clearly acknowledged.
5) The pharmaceutical industry welcomes broad funding of patient organisations from multiple
sources.

This code applies to relationships between members of the Association and patient organisations
duly organised and existing on the territory of the Republic of Croatia. The following codes and
applicable laws shall apply (hereinafter: Applicable Codes) in following cases:
a) if the pharmaceutical company has a company seat within Europe – the industry code of the
country in which the pharmaceutical company has a company seat;
b) if the pharmaceutical company has a company seat outside Europe – the EFPIA Code of
practice on relationships between the pharmaceutical industry and patient organisations;
c) in the case of partnerships and activities taking place in a particular country within Europe –
the industry code of the country in which the activity takes place; or
d) in the case of cross-border partnerships and activities – the industry code of the country in
which the patient organisation has its main European organisation.
In the event of a conflict between the provisions of the Applicable Codes set forth above, the more
restrictive of the conflicting provisions shall apply.

In this Code the following terms shall have the following meanings:
Patient Organisation means association or other form of organising of patients providing health
services and social care in the Republic of Croatia on non-profit basis which
has been funded and acts with the goal of achievement and protection of
the interests of its members including associations (domestic and
international) whose members or associates are associations;
Europe the term which in the context of provision of applicability of this Code, in
line with the definition of EFPIA, includes those country members of EFPIA
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with their own codes of practice;
Pharmaceutical
Company
members of Association, their branch offices and all affiliated companies in
the sense of Croatian Company Law that in any way provides funds or
supports the activities of the Patient Organisations. For the purpose of this
definition, the term „activities“ shall mean any interaction covered with any
Applicable Code, including the provision of funding.

Valid provisions of legislation prohibiting advertising of prescription-only medicines to the general public shall apply to this Code.

1. A Pharmaceutical Company and a Patient Organisation must have in place a written agreement
always where Pharmaceutical Company provides financial support, significant indirect support
and/or significant non-financial support to the Patient Organisation. Written agreements must state:
 the amount of funding,
 the purpose (e.g. unrestricted grant, specific meeting or publication etc.),
 description of significant indirect support (e.g. donation of public relations donation
agencies, time and nature of their involvement) and significant non-financial support,
 the statement on the Applicable Code within the meaning of the provision on applicability of
this Code.
2. All agreements must pass the internal approval process of each Pharmaceutical Company, in line
with the internal procedures on approval of legal documents (if any).

The public use of a Patient Organisation’s logo and/or proprietary material by a Pharmaceutical Company requires written permission from that Organisation. In seeking such permission, specific purpose and the way the logo and/or proprietary material will be used must be clearly stated.

Pharmaceutical Companies must not seek to influence the text of Patient Organisation material they sponsor in a manner favourable to their own commercial interest. This does not preclude companies from correcting factual inaccuracies. In addition, at the request of Patient Organisations, companies may contribute to the drafting of the text from a fair and balanced scientific perspective.

  1. a) Each Pharmaceutical Company must make publicly available a list of Patient Organisations to
    which it provides financial support and/or significant indirect/non-financial support. This
    should include a short description of the nature of the support that is sufficiently complete to
    enable the average reader to form an understanding of the significance of the support. The
    description must include the monetary value of financial support and of invoiced costs. For
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    significant nonfinancial support that cannot be assigned a meaningful monetary value the
    description must describe clearly the non-monetary benefit that the patient organisation
    receives. This information may be provided on the European level and should be updated at
    least once a year.
    b) Pharmaceutical Companies must ensure that their sponsorship is always clearly
    acknowledged and apparent from the outset.
    c) Each Pharmaceutical Company must make publicly available a list of Patient Organisations
    that it has engaged to provide significant contracted services. This should include a
    description of the nature of the services provided that is sufficiently complete to enable the
    average reader to form an understanding of the nature of the arrangement without the
    necessity to divulge confidential information. Pharmaceutical Companies must also make
    public the total amount paid per patient organisation over the reporting period

It is permitted to engage Patient Organisations as experts and advisors for services such as participation at advisory board meetings and speaker services at Events. The arrangements that cover consultancy or other services must, to the extent relevant to the particular arrangement, fulfil all criteria provided in Art. 16.1. of the Code of conduct in promotion of prescription-only medicinal products of innovative Pharmaceutical Companies to healthcare professionals in the Republic of Croatia and interactions with Healthcare Professionals (hereinafter: HCP Code).

No Pharmaceutical Company may require that it be the sole founder of a Patient Organisation or any of its major programmes.

Provisions of Article 11 of the HCP Code shall apply accordingly.

Provisions of Title VI, “Enforcement”, Art. 24 – 39 of the HCP Code shall apply accordingly.

1. This Code is adopted by the General Meeting of the Association at its session held on 30 June 2014
in line with Article 16 of the Statute of the Association.
2. This Code shall enter into force on 01 July 2014 and shall be binding for all members of the
Association from that date.

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President of the Association:
Karolina Matić

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