Methodological note

METHODOLOGICAL NOTE – DESCRIPTIVE PART
Last updated on June 26th, 2019

1.0 INTRODUCTION
Having the trust of society is key for Ferrer. Therefore, in response to social demands and full confidence in the sector, all interrelationships between organizations and health professionals are published.
The collaboration with this initiative of the pharmaceutical industry, a pioneer in the world, is the result of Ferrer's commitment to constantly improve its relationships with third parties.
The interrelations that are published are necessary and legitimate for the sector. They are the basis of scientific research and training. These relationships help to have a better knowledge of the diseases and treatments available and facilitate the development of new innovative medicines. Value transfers, through these interrelations, are a fundamental tool to update and improve the knowledge and skills of health professionals and, in addition, allow the pharmaceutical industry to incorporate the experience and knowledge of organizations and health professionals to research pharmaceutical.
Ferrer's mission of advancing the welfare of society affects not only the way of working but also the activities that are promoted at the level of corporate social responsibility: creation and support for foundations, training for health professionals, initiatives to reduce the marginalization of certain groups within the health system, support for patients, active investigation of infectious diseases in developing countries and collaboration in local projects.
Another area of ​​special importance for Ferrer is environmental sustainability. There is a firm commitment to a business model that promotes sustainability and environmental awareness

2.0 SCOPE
Ferrer will publish on its corporate website on an annual basis all the collaborations related to prescription drugs made with each and every one of the members of the national health system (organizations and health professionals), whether private or public, as well as institutions around the R & D, as proof of Ferrer's firm commitment to maintain a transparent relationship with society. Naturally, these publications will respect the requirements of the General Data Protection Regulation.
In this report, all transfers made by each of the business areas during calendar years will be added, broken down by concepts according to the guidelines of the Freiwillige Selbstkontrolle für die Arzneimittelindustrie e.v. (FSA) and the European Federation of Associations of the Pharmaceutical Industry (EFPIA).
These interrelationships, whether direct or through third parties, involve transfers of value made between Ferrer in Germany and German healthcare professionals and healthcare organizations.

3.0 GLOSSARY OF TERMS

• Accommodation: It is the cost of the hotel during the days of the event. The maximum category used is four stars, except if the conditions accepted by FSA are met. The dates of the hotel reservation must coincide with the days of the event.

• FSA Code of Conduct: The code of the FSA, which transposes the regulations of the European Federation of Associations of the Pharmaceutical Industry (EFPIA), aligning the German system of self-regulation with the rest of existing systems in Europe on the promotion of prescription drugs and interrelation with professionals and health organizations. Congresses or scientific meetings: Training events organized by scientific societies of different medical specialties to present the latest scientific advances. They also allow to initiate collaboration processes between Ferrer and healthcare professionals (HCP) for possible research projects. They usually have an annual or biannual periodicity. No companions of the HCP or associated play activities are allowed. Publication consent: Document signed by the HCP in which it states whether or not it consents to the publication of its data individually or in aggregate.

• Travel expenses: Cost of the displacement from the place of residence of the HCP to the place where the congress is held. The HCP whose journeys are financed by Ferrer can only travel in economy class flights. In cases where trips last longer than five hours, a business class flight may be provided. Travel by train in Germany may be booked in 1st class. The dates of the trip are limited to the event, you can’t go before or stay after the end of it.

• Recipient: Any HCP or HCO as applicable, in each case, whose primary practice, principal professional address or place of incorporation is in Germany.

• Donation (monetary contribution or benefit in kind): Act by which Ferrer contributes an economic or in kind amount in favour of a third party (donee), who accepts it. In any case, Ferrer will not obtain or request any consideration from the donee.

• EFPIA: European Federation of Associations of the Pharmaceutical Industry (EFPIA). Represents the pharmaceutical industry that operates in Europe. Thanks to the direct participation of 33 national associations and 39 pharmaceutical companies, EFPIA is the voice in the EU of 1,900 companies committed to research, development and being able to provide new medicines that improve the health and quality of life of patients in all the world.

• Events: Any scientific-professional meeting, congress, conferences, symposium, day, in-person or distance training courses, or any other similar activity (including, but not limited to, meetings of experts, visits to manufacturing plants and research facilities, as well as training meetings, of researchers related to the conduct of clinical trials and post-authorization studies) that are organized or sponsored by Ferrer or under its control through third parties.

• Professional fees: Amount received by the HCP after having performed a service for Ferrer as stipulated by contract. These services provided will always have a purpose of research, advice or training. Travel expenses and derived accommodation are not included.

• Registration: The price set by a secretariat that must be paid as a compulsory fee so that the HCP can access a scientific congress and participate in the training sessions.

• Interrelation: Activities carried out, organized or sponsored by Ferrer or by third parties (suppliers, agencies...) from which direct or indirect contributions, support and / or consideration of any kind in favour of a third party may be derived.

• Research and Development: Activities associated with the design or execution of preclinical studies (defined by the OECD in "Principles of Good Laboratory Practices"), clinical trials (defined in Directive 2001/20 / EC and contemplated in Article 14.1 of the Code) and post-authorization studies (referred to in Article 14.2 of the Code).

• Organization of patients: Non-profit organization -including the umbrella organizations to which they belong-, composed mainly of patients and / or their caregivers, who represent and / or support the needs of patients and / or their caregivers.

• Health Care Organization: Any legal entity or entity that is a medical or scientific association, health institution (whatever its legal or organizational form) such as hospitals, clinics, foundations, universities and other academic entities, scientific societies (excluding patient organizations), or through which one or more health professionals provide services.

• Sponsorship: Amount of money contributed to legal entities (hospitals, clinics, foundations, universities ...) for the realization of congresses or research projects, such as a stand or other expenses incurred in the environment of a scientific meeting, a website of a medical society or newsletters, among others.

• Market Price: Amount that a private person should generally pay to acquire a unit of a good, product, material, article or similar, in Spain.

• Health Care Professionals (HCP’s): Any member of the medical profession, dentist, pharmacist, nurse or podiatrist who, in the exercise of their profession, carries out actions related to the sale, distribution, administration or prescription of medicines. Also taking into account the professionals who are responsible for the distribution of medicines (wholesalers) and people who work in the administration, managers of centers for health.

• Aggregate disclosure: the sum of the value transfers made to HCP that could not be reported on the individual publication.

• Individual disclosure: The receiver of the transfer can be identified and the full name and address can be found.Individualised disclosure will be done only with consent of the HCP concerned respecting the requirements of the General Data Protection Regulation. All transfers to an organisation and public will be published individually.

• Technical Secretary: Official company hired by the HCO organizing a scientific event for its management and coordination.

• Scientific Society: Association of HCP in relation to a pathology that allows them to meet, share information and knowledge and disseminate their work through specialized publications.

• Transfer of value: Any payment or direct or indirect consideration in cash, in kind, or in any other way, regardless of its purpose.

• Direct transfer: transfer of value made directly by the laboratory to the beneficiary, without an intermediary.

• Indirect Transfer: when it is a third party (suppliers, agents, partners or affiliates), acting on behalf of the company, the transfer of value for the benefit of a recipient and the company identifies or can identify the recipient.

4.0 COLLECTION OF INFORMATION TO BE PUBLISHED AND IDENTIFICATION OF THE ADDRESSEES
4.1 INFORMATION COLLECTION AND PROCESSING
4.1.1 COLLECTION OF INFORMATION
Relevant data from all executed contracts that involve a transfer of value to a HCP or HCO are collected in a list. Here it is also noted whether or not a HCP has consented to publication of his personal data.

4.1.2 DATE FOR COLLECTION AND PUBLICATION
All collaborations made in a calendar year will be compiled and will be published six months after the close of each year. The publication will accumulate the data to have three full years. As of that moment, the information of the first year will be replaced by that of the fourth year, and so on.

Criteria for assigning dates to transfers for publication:

• In the case of a scientific event (sponsorship of stands, symposia, registrations, trips and accommodation, etc.), it is published by virtue of the start date of the event.

• When publishing professional fees related to the provision of training services, the start date of the associated scientific event, which has a program that includes the venue and the date of the event, will be reflected.

• For the professional fees related to a consultancy or other type of activity not linked to a scientific event, the start date of the processing of the payment for the service provided is taken into account.

• Regarding donations, the date of the action is taken as reference. Through this process, compliance with the accounting principle of the accrual of interrelation is guaranteed. That is to say, it is guaranteed that the payment is only made at the moment of the service provision.

4.1.3 VAT CONSIDERATION
All values are listed with the net amount. Thus the actual amount paid to a HCP or HCO may have been higher depending on whether or not the transfer involves VAT.

4.1.4 CURRENCY PROCESSING
Values are published in Euro. In the event that a transaction occurs in a currency other than Euro, the exchange rate published by the European Central Bank on the date of registration is applied and the exchange rate of payment is applied at the time of effect, causing a difference of type of change that is recorded in the financial statements.

4.1.5 TRANSFERS OF VALUE THAT DO NOT TAKE PLACE
In those cases in which a transfer of value is made to a HCP for attending a congress (registration, transfer and accommodation) but finally it can’t attend, the cancellation costs that are assumed by Ferrer are published. If the non-attendance is known in time, the order is cancelled without associated costs and, therefore, it is not published.
In the case of other transfers that are not carried out, for example, fees and donations, and do not incur an associated expense, they are not published.

Exceptional pandemic situation: Due to the COVID-19 pandemic during 2020, most of the congresses and scientific events have been cancelled, postponed or have changed to a virtual format. For the exercise of transparency, the following assumptions have been considered:

· Direct or indirect value transfers to HCP and HCO for collaborations that could not be carried out in 2020 for the above reasons, are not published in this report.  When Ferrer had to pay a cancellation fee and has received some kind of service in return (e.g. publication of the Ferrer logo, than these values are published.

· Transfers linked to events that have been altered in nature but have been made during 2020 (eg registration in a face-to-face event that becomes a virtual event registration with another cost, or amount for a face-to-face stand that becomes a sponsorship of a banner in virtual congress) are published with the realized value.

4.2 RECIPIENTS IDENTIFICATION
4.2.1 CHARGING PAYMENTS (cases of several receivers).
Transfers of value are considered individually for those events with more than one HCP sponsored by Ferrer. Unit costs of tickets, accommodations and inscriptions directly associated with each HCP will be reported separately.

4.2.2 CROSS-BORDER TRANSFERS
The transfer of value related to a German HCP that carries out its activity in EFPIA territory other than Germany, but that has been managed from Ferrer Deutschland is made transparent on the German part of the website www.ferrer.com.

As for foreign HCP, the publication will make transparent all the transfers of value that are earned from Ferrer Deutschland
The transfer of value related to a German HCP that carries out its activity Germany, but that has been managed from Ferrer Headquarters in Spain is made transparent on the Spanish part of the website www.ferrer.com.

4.2.3 TRANSFERS MADE BY INTERMEDIARY COMPANIES
For the organization of scientific events, Ferrer can occasionally hire intermediary companies that oversee the value transfers to the HCPs (fees for papers, trips, registrations, accommodations ...) and to the HCO (stands in congresses, collaborations in projects ...). For publication, these indirect value transfers will be treated in the same way as those made directly through Ferrer.
In order to carry out indirect value transfers, a contract is always signed in which the intermediaries undertake to comply at all times with the legislation in force during the validity of the legal document. There is also a special observance of the tax legislation in its payment obligations to the speakers, being the intermediaries the only responsible before them and against third parties for the breach of the tax regulations.
In addition, these intermediaries also undertake to comply with the FSA Code of Conduct and, likewise, transfer this obligation to the HCP and HCO contracted by them.

4.2.4 TRANSFERS OF VALUE TO HEALTH CARE PROFESSIONAL TROUGH TECHNICAL SECRETARIATS
In the event that an HCP is contracted for services, but payments are made to an associated HCO, the publication of the transfer of value will occur in the HCP section.

For example: Dr. X provides scientific advice for Ferrer's fees. Payments are made to Dr. X. Clinic, which is a healthcare organization. Still, Ferrer publishes this transfer in the HCP section.

4.2.5 UNIVERSITIES AND ACADEMIC INSTITUTIONS
Since the universities and academic institutions are considered health organizations, it will be treated as described in the transfer sections to HCO. If the project is a research and development project, the transfer of value will be published in the R & D section (see section 5.4).

4.2.6 ORGANIZATIONS OF CLINICAL RESEARCH
All payments made to HCP through clinical research organizations (CROs) will be reflected as indicated in section 5.4 of research and development. Ferrer has adequate computer systems to classify the transfers made to CROs according to their nature.

5.0 CATEGORIES OF TRANSFER OF VALUE
5.1 DONATIONS TO HEALTH CARE ORGANIZATIONS
Donations can be monetary or in kind - through the donation of products, for example. In any case, they are irrevocable donations for the purposes established by the HCO.
Any of these donations goes through an internal approval process to confirm that it meets the requirements of the FSA Code of Conduct. In the case of donations in kind, the applicable legislation or code will always be respected according to the type of product.

5.2 COLLABORATION IN SCIENTIFIC AND PROFESSIONAL MEETINGS
Ferrer participates in scientific and professional meetings organized by third parties, as scientific societies.
In addition, sometimes Ferrer organizes its own scientific events always following the guidelines set by the FSA.
Among the criteria for internal and external scientific meetings established by the FSA are the following:

• They should preferably be organized by a recognized medical scientific society.

• Events must be of an exclusively scientific-professional nature. Entertaining or recreational elements or activities are not allowed.

• Scientific objectives should be the main focus in the organization of meetings.

• Hospitality should not be extended to people other than HCP.

• In any case, a maximum cost per guest of 60 euros (including taxes) is established for any form of hospitality associated with meals and / or lunches.

• Payments can’t be made in favour of physicians or groups of physicians, either directly or indirectly, to rent rooms for meetings. When meetings, congresses, symposiums and similar events are sponsored by Ferrer, it will be recorded in all documents related to the meeting and also in any work, paper or document published in relation to them.

• The payment of reasonable fees and the reimbursement of personal expenses, including travel, to the moderators and speakers of these meetings, congresses, symposiums and similar professional or scientific acts is acceptable.

• Events that take place outside of Germany will not be organized or sponsored unless it makes more sense from a logistical point of view, because:

  • Most of the invited participants come from abroad

  • A relevant resource or expertise is located abroad and is the main purpose of the event.

• The selection and sponsorship of HCP for its attendance at events must comply with the criteria contained in the applicable codes.

• In no case can money be offered to merely compensate the time used by the HCP to attend the event.

5.2.1 COLLABORATIONS / SPONSORSHIP WITH THIRD PARTIES ASSIGNED BY HEALTH CARE ORGANIZATIONS FOR EVENT MANAGEMENT
In the case of sponsorship of scientific events, through stands or symposia among others, the value transfers related to participation will be transparent, without including the logistical, construction or design costs.
For each congress the official secretariat publishes on its web page or through a document that distributes to the pharmaceutical industry the rates for the sponsorship of stands, symposiums, etc.
Ferrer hires and makes payment of the sponsorship to the official secretariat, although the transfer of value is made transparent in the name of the scientific society (HCO) that organizes the congress. Therefore, although the HCO at no time receives payment from Ferrer, in the publication will be reflected as a recipient of it.

5.2.2 REGISTRATION FEES
Ferrer will publish the cost derived from the registration fee for congresses. This gives the right to access the event site and all the scientific sessions of a training nature that can be organized around the congress.
In all cases, the prices of the inscriptions are set by the HCO that organizes the congress, never by Ferrer, and they are published on the official website of the congress. The prices of the registration for the same scientific event may vary depending on whether the HCP is a member of the OrganizingHCO, if it is a Resident
of Medicine, etc.
The registration fee is paid directly to the secretariat of the organization, never to the HCO. The cost of registration is never reimbursed directly to the HCP.

5.2.3 TRANSFERS AND ACCOMMODATIONS
In cases in which the assistance of a HCP to a scientific event involves travel and / or accommodation, Ferrer can sponsor this cost. For this, a series of requirements must be met:

• The dates of the reservation, both accommodation and travel, should always be limited to the days of the congress and no companions are allowed.

• Regarding the displacement, Ferrer takes charge of the cost of the displacement from the place of residence of the HCP to the place where the congress is held. Travel costs are covered in line with the FSA Code of Conduct.

• In the case of accommodation, Ferrer assumes the cost of the hotel during the days of the congress according to the requirements of the FSA Code of Conduct..

Travel may be organised either directly by Ferrer or by the HCP. In case of travel organised by the HCP, the criteria for appropriateness are communicated within the contract for services. Reimbursement only is granted when the HCP submits the original tickets for out of pocket expenses.

5.3 PROVISION OF SERVICES
To meet the research and training objectives mentioned at the beginning of this document, the HCP and HCO provide various services to Ferrer through training talks, scientific advice or participation in scientific studies, among many others.

5.3.1 HONORARIUMS
Ferrer contracts, among others, the following services to HCP and HCO:

• Presentations at scientific meetings as a lecturer or moderator

• Training sessions

• Participation in studies

• Expert meetings

The agreements with the HCP individually and / or with the HCO must comply, among others, with the following conditions, according to the FSA Code of Conduct:

• They will aim to collaborate with health care, research, teaching / training, or the organization of professional or scientific events

• There must be a written contract prior to the provision of these services.

• The provision of this service must be justified.

• The number of contracted HCPs must be reasonable to meet the stated objective.

• Ferrer must maintain documentary support of the services provided

• The hiring of the HCP should not constitute an incentive for the recommendation, prescription, purchase, supply, sale or administration of a certain medicine.

• The remuneration of the participating professionals must obey market criteria and be commensurate with the time spent, the work done and the responsibilities assumed.

• The remuneration must be monetary.

In Ferrer there are efficient internal controls to approve each of the contracts in advance, monitor them and verify their compliance with the Code of Conduct of FSA.
The contracting of these services is done directly or by subcontracting through a specialized external company, which may be a clinical research organization, a technical secretariat or a project management company. The regulatory and fiscal implications for Ferrer do not vary independently of the contracting method followed.

The provision of services performed by employers or professionals is subject to VAT or personal income tax according to the applicable regulations in force.

5.4 RESEARCH AND DEVELOPMENT
Ferrer's deep commitment to innovation has led us to pursue a decentralized model of research. Ferrer has corporate and independent research units and pursues a strategy based on collaborations and alliances with public research groups and biotechnology companies of recognized prestige.
A research model of this nature implies that Ferrer's interrelation with these groups must be regulated through formal agreements. In these contracts, both parties express the purpose of the interrelation, reflecting their drive for R & D. In this section of the publication we include all those activities associated with the design or execution of preclinical studies, clinical trials and post-authorization studies, as well as the amount related to the expenses of the fees, meetings and scientific events related to these studies.
Preclinical studies are carried out with animals, before being tested in humans, to discover if a medicine, a procedure or a treatment is likely to be useful. The clinical trial already involves the experimental evaluation of a drug, a procedure or a treatment in humans to assess its efficacy and safety.
Finally, the post-authorization studies represent any clinical or epidemiological study carried out during the marketing of a medicine according to the conditions authorized in its technical sheet, or under normal conditions of use, in which the medicine or the medicines of interest are the factor of fundamental exposure investigated. In compliance with the FSA transparency code, these transfers related to R & D are published in an aggregate manner.

6.0 PERSONAL DATA PROTECTION
6.1 COMPLIANCE WITH THE APPLICABLE LEGISLATION ON THE PROTECTION OF PERSONAL DATA
In accordance with the provisions of Regulation (EU) 2016/679, of April 27, on Data Protection (GDPR), Ferrer will publish personal data of HCPs related to the transfer of value only if the HCP has consented to it. A consent is requested as part of each contract for a service or via a separate consent form. An HCP may withdraw the consent to publication at any time – in this case all transfer of values to this HCP within the current calendar year will be disclosed in aggregated form.
Once data are already published, if the HCP does no longer agree with the published information or sees any error in the publication of its data, it may exercise, as the current regulations protect it, the rights of access, rectification, deletion (right to be forgotten), treatment limitation, portability and opposition.

These rights are the set of rights through which the General Data Protection Regulations (GDPR) guarantee natural persons the power to control their personal data. The procedure to exercise these rights can be seen detailed in section 6.2.

6.2 ACCESS OF HCP AND HCO TO THEIR INFORMATION
Once all value transfers have been published, any health professional who has received value transfers from Ferrer may, in any case, exercise the rights of access, rectification, deletion (right to be forgotten), treatment limitation, portability and opposition provided for in the Regulation by means of a letter addressed to Ferrer Deutschland GmbH, TPH III- B, Kaiserstraße 100, 52379 Herzogenrath or by e-mail to the dataprotectionDE@ferrer.com address along with its identification through the National Identity Card and indicating as reference "Transfers of value".
By way of clarification, the rights consist of:

• Access: The data subject's right to obtain information about their own personal data that is the object of processing, as well as the information available on the origin of said data and the communications made or anticipated from them.

• Rectification: Right of the affected, previous justification and with timely documentation, to modify the data that prove to be inaccurate or incomplete.

• Suppression (right to be forgotten): Right of the affected party to obtain, without undue delay, the deletion of personal data concerning him.

• Limitation: Right of the affected party to obtain from the data controller the limitation of the treatment when the conditions established in the Regulation are met.

• Portability: The affected party's right to transmit personal data of one controller to another, without impediments.

• Opposition: The affected party's right not to carry out the processing of their personal data individually in cases where the SP gives its consent for the publication in an aggregate manner and the data have been published individually.

7.0 PUBLICATION
7.1 REVIEW PRIOR PUBLICATION
Before publishing the data regarding the value transfers that Ferrer has made during the calendar year, the information on value transfers to HCP and HCO related to prescription drugs is verified. In the case that any personal information is missing, or any possible inconsistency or error is detected, the HCO or the HCP is contacted to complement or verify the data available so that the publications are as accurate as possible.

7.2 DATA ACCESS
All the data referring to the transfers of value made by Ferrer Deutschland, directly or indirectly, will be published on the German section of the corporate website.

7.3 LANGUAGE
The information is published in German.

8.0 REFERENCE DOCUMENTS
FSA–Kodex zur Zusammenarbeit mit Fachkreisen („FSA-code of good practice“)
FSA–Kodex zur Transparenz bei der Zusammenarbeit mit den Angehörigen der Fachkreise und medizinischen Einrichtungen („FSA-transparency code“)

9.0 LEGAL NOTICE ON THE PROCEDURE OF PUBLICATION ON THE FERRER
WEBSITE
It uses a combination of automated systems, standardized procedures and manual data entry through internal and external resources to collect relevant information and its subsequent publication. The information published reflects the good faith to comply with the provisions of the FSA transparency code. In the event that, despite the best efforts to ensure a publication that faithfully reflects the value transfers carried out, it has not been possible to include correct and complete information, it will be investigated and an appropriate response will be given in the event that the information is incorrect as detailed in articles 6.4 and 7.1.
The information published according to the requirements of the Code on this website will be used only in order to comply with the provisions of the Code.
The HCP or HCO that consult the published data will be subject to the acceptance of the conditions of use of the Ferrer website, which can be found on the Ferrer general page or consult directly through the link: http://ferrer.com / Terms-of-use-of-the-web.