INTRODUCTION

1.1 Cooperation with Healthcare Professionals and Organisations

Our society requires the pharmaceutical industry to be in a position to supply the best medicinal products possible. To do this, investment must be made in Research and Development, which inevitably requires close cooperation with Healthcare Organisations and Professionals.

Since 2014, the pharmaceutical industry has voluntarily made new commitments as regards transparency, and since 2016 all laboratories subscribing to the Pharmaceutical Industry Code of Practice have taken the initiative of disclosing, on their respective websites, transfers of value to Healthcare Professionals and Healthcare Organisations as regards donations, educational activities, services supplied and research and development undertaken over the preceding year.

The aim of disclosing such information is to make pharmaceutical industry interactions with Healthcare Organisations and Professionals entirely transparent.

It is essential for these types of cooperation to be transparent, and for society to be confident that they take place for the purpose of developing new medicinal products, for ensuring ongoing medical education for healthcare professionals, that they are applied to clinical practice and that their common aim is to enhance patient care in the widest sense of the term.

Healthcare Professionals contribute the expertise and independent perspective acquired as a result of their clinical and professional experience, sharing it with the pharmaceutical industry and other colleagues in the healthcare profession for the purpose of promoting better-quality patient care. These services are fundamental for the industry and help design and shape the activities it carries out.

You may obtain further information about this initiative by visiting the website www.codigofarmaindustria.org

1.2 Cooperation with Patient Organisations

The pharmaceutical industry researches, develops and markets medicinal products for preventing or curing diseases, alleviating or eliminating their symptoms and improving patient life expectancy and quality of life. In this context, the relationship between pharmaceutical companies and patients is a crucial one.

In recent years, thousands of citizens who are patients or caregivers and who share common interests, needs and challenges as regards their disease or ailment have set up organisations to represent them. The existence of organisations such as these has enabled diverse healthcare stakeholders, amongst whom the pharmaceutical industry, to create and maintain a fluid relationship with patient groups.

The pharmaceutical industry sets up and manages cooperation activities with all kinds of patient organisations in diverse areas, among them promotion of healthy lifestyle habits, health education, social awareness-raising, health and social care programmes, and promotion of biomedical research.

With a view to ensuring that relationships between the pharmaceutical industry and patient organisations are managed ethically and transparently, in 2008 Farmaindustria (the Spanish Association for the Pharmaceutical Industry in Spain) approved the Spanish Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations. In 2014, the content of this Code was included in a single document, the Pharmaceutical Industry Code of Practice, the 2016 version of which is currently in force.

In compliance with the prevailing legal framework, the Code is intended to respond to any issues which may arise and to provide guidelines for action and specific rules which govern laboratory conduct in this respect. The rules set out in articles 17 and 18 ensure that industry relationships with patient organisations are based on the principles of independence, mutual respect, non-promotion, transparency and plurality of funding sources.

AIM OF THIS INITIATIVE

The aim of this initiative is to foment the credibility of and trust in the pharmaceutical industry as a whole, and in the relationships between pharmaceutical laboratories and Healthcare Professionals, Healthcare Organisations and Patient Organisations.

To this end, the initiative:

  • Promotes the transparency of these relationships, particularly when they entail payments or transfers of value.
  • Provides information on the nature and scope of these relationships.
  • Helps to identify these relationships and to clarify, among other questions, in what way they are necessary for the development of new medicinal products and ensuring their rational use.
WHAT IT PROVIDES

For patients and the general public: information as regards the different forms of cooperation between laboratories and Healthcare Organisations, Healthcare Professionals and Patient Organisations, and the added value that this cooperation represents for society.

For Healthcare Professionals and Organisations: it enables the valuable work of pharmaceutical laboratories in areas such as Research and Development and continuous medical education to be quantified.

For Patient Organisations: it ensures that companies interact with patients and their representative organisations in a proper manner which respects the principles of independence, mutual respect and transparency.

For researchers: it states the proportion of total investment in R&D paid by laboratories to researchers and research establishments.

For pharmaceutical laboratories: it accredits their commitment to cooperation and continuous improvement, the legitimate requirement for such cooperation, and their commitment to undertaking it in strict compliance with the ethical principles of professionalism and responsibility.

WHAT INFORMATION IT INCLUDES

Transfers of Value from the pharmaceutical laboratory to Healthcare Organisations, Healthcare Professionals and Patient Organisations as regards:

Donations (applicable only to Healthcare Organisations and Patient Organisations).

Example: donation of scientific books to a public hospital.

Educational activities and meetings between scientists and professionals, indicating if the transfer of value is intended to cover the costs of: 

a) Sponsorship of the activity (applicable only to Healthcare Organisations and Patient Organisations).
b) Registration fees.
c) Travel and accommodation.

Example: assistance for attending an annual conference organised by a scientific society.

Provision of services, indicating if the transfer of value is intended to cover the costs of: 

a) Fees.
b) Expenditure relating to provision of services.

Example: contracting a Healthcare Professional to provide a laboratory with advice or consultancy services for a given matter.

Research and Development.

DEFINITIONS

Interaction: activities performed, organised or spon¬sored by a pharmaceutical company, or under its control (including subsidiaries, foundations, associations, insti¬tutes, agencies, third-party providers, etc.) from which direct or indirect contributions, support and/or considerations of any kind may be made to a third party.

Patient Organisation: a not-for-profit organisation (including the umbrella organisation to which it belongs), mainly composed of patients and/or caregivers, that represents and/or supports the needs of patients and/or caregivers.

Healthcare Organisation: any legal person/entity (i), whether a medical or scientific association, healthcare institution (regardless of its legal or organisational form) such as a hospital, clinic, foundation, university or other academic entity, scientific society (excluding the Patient Organisations described in article 17 of the Farmaindustria Code of Practice), or (ii) by means of which one or more Healthcare Professionals provide services.

Healthcare Professional: any natural person who is a member of the medical, dental, pharmacy, nursing or chiropody professions or any other person who, in the course of his/her professional activities, may prescribe, purchase, supply, dispense or administer a medicinal product for human use.

Transfers of Value: any direct or indirect payment or consideration, whether in cash, in kind or otherwise. This includes direct financial transfers and indirect benefits, such as payment of travel expenses or registration fee for a scientific conference.

1. FORM OF DISCLOSURE OF INFORMATION

Pursuant to the provisions of articles 19.1 and 19.2 of the Farmaindustria Code of Practice, direct or indirect transfers of value to recipients shall be recorded and disclosed.

Pursuant to article 7f) of Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data, there is a legitimate interest for companies subscribing to the Code to be transparent, acknowledged in the Spanish Data Protection Agency report dated 22 April 2016, whereby the prior consent of interested parties to disclosure of data on an individual basis and transfers of value from January 2017 onwards is not required. In this respect, pharmaceutical laboratories are required to inform Healthcare Professionals that their data will be disclosed in accordance with the provisions of the Farmaindustria Code of Practice.

Consequently, any Healthcare Professional who is the subject of a Transfer of Value by REIG JOFRE must be sent a document providing information on how their personal data will be processed, for what purpose, the type of collaborative work with the laboratory, and the amount of the Transfer of Value. The Healthcare Professional shall fill in the data required on the document, sign it and return it. All Transfers of Value to Healthcare Professionals shall be disclosed on the REIG JOFRE website in the TRANSPARENCY section.

Transfers of Value to Healthcare Organisations shall similarly be disclosed on an individual basis.

Research and Development data shall be disclosed as a single aggregate amount per laboratory.

That the Research and Development amount reported does not match that amount shown in other sections is due to the fact that this section only includes amounts paid for R&D to Healthcare Professionals and Healthcare Organisations not linked to REIG JOFRE. Using this criteria, the costs relating to items such as in-house staff, materials, patents and equipment are excluded.

Transfers of Value to Patient Organisations shall be disclosed on an individual basis and shall contain the following minimum information: name of organisation, type of cooperation, name of activity, description of activity and Transfer of Value amount.

2. WHEN INFORMATION IS DISCLOSED

Information on Transfers of Value to Healthcare Professionals and Healthcare Organisations shall be disclosed during the first six months of each year, including any activities performed during the previous year.

Information on Transfers of Value to Patients Organisations shall be disclosed during the first quarter of each year, including any activities performed during the previous year.

This notwithstanding, REIG JOFRE will adjust Transfers of Value disclosure dates as instructed each year by Farmaindustria.

3. DATA COLLECTION

All of the data disclosed by REIG JOFRE are subject to a disclosure procedure which ensures compliance with the obligations specified in article 18 of the Farmaindustria Pharmaceutical Industry Code of Practice.

Data will remain in the public domain for a minimum of 3 years after disclosure, unless a shorter period is established by law, or the data owner revokes their consent in a manner which is legally binding on our laboratory. Similarly, the documentation justifying and accrediting Transfers of Value shall remain in the public domain for a minimum of 5 years after the end of each applicable period, unless a shorter period is established by law.

For contracts of a term longer than one year, the proportional part shall be attributed to each calendar year.

All amounts are reported net, excluding taxes.

Annual Transfers of Value to individual Healthcare Professionals or Healthcare Organisations shall be added together in such a way that a total amount is reported for each individual Healthcare Professional or Healthcare Organisation. Amount breakdown shall only be available for consultation, if appropriate, by the individual Healthcare Professional or Healthcare Organisation, the bodies responsible for monitoring the Code of Practice, and the relevant authorities.

Information which may not be reported individually for legal reasons shall be reported in an aggregate manner.

4. DATA PROTECTION

All of the data disclosed by REIG JOFRE are subject to a disclosure procedure which ensures compliance with the obligations specified in article 18 of the Farmaindustria Pharmaceutical Industry Code of Practice.

Access to personal data shall be restricted to authorised COMPANY staff and, where applicable, the relevant authorities, when such data is required for checking information and procedures, and shall always be kept confidential in accordance with in-force legislation.

In the event of a Healthcare Professional wishing to exercise the rights described in the GDPR, EU General Data Protection Regulation 2016/679, (rights of information, access, correction, deletion, treatment limitation, data portability and opposition), they shall request same by writing to LABORATORIO REIG JOFRE, S.A., Gran Capità 10, 08970 Sant Joan Despí, Barcelona, Spain, or by email to rgpd@reigjofre.com.

5. ADAPTING DATA DISCLOSURE TO THE MEASURES PROPOSED BY THE SPANISH DATA PROTECTION AGENCY

REIG JOFRE uses a combination of computerised systems, standardised procedures and manual data entry, either in-house or outsourced, for the purpose of data collection and subsequent disclosure.

REIG JOFRE will adapt its corporate website by implementing the measures proposed by the SPANISH DATA PROTECTION AGENCY for the purpose of preventing any subsequent inappropriate data processing by third parties.  Specifically, it will adopt protocols which prevent data from being indexed by search engines.

Data disclosure does not entitle individuals accessing the website to perform any additional processing of the data of professionals, such as linking these data to data posted on associated websites.

The information disclosed reflects our good faith and utmost efforts to comply with the provisions of article 18 of the FARMAINDUSTRIA Pharmaceutical Industry Code of Practice. Should we fail to include full and correct information, we shall investigate such failure and respond quickly and appropriately.

Open Transparency Report 2019

Open Transparency Report with Patient Organizations 2019

Open Transparency Report 2018

Open Transparency Report 2017

Open Transparency Report 2016

Open Transparency Report 2015