Methodological Note 2021 (Legacy GW HCO/HCO Report)
Methodological Note for Activity
Purpose
The relationship between the pharmaceutical industry and healthcare professionals (HCPs) and healthcare organizations (HCOs) plays a vital role in the development and delivery of life-enhancing and life-saving medicines. It is a relationship that we at GW Pharmaceuticals, now a part of Jazz Pharmaceuticals, are proud of. At the core of the relationship is sharing knowledge to improve outcomes for patients. We want to ensure that patients and others have confidence that this relationship is open and transparent, which is why the pharmaceutical industry is taking the lead on disclosing details of payments and other benefits in kind made by industry to HCPs and HCOs.
Approach to Disclosure
The EFPIA (European Federation of Pharmaceutical Industries and Associations) Code also requires member companies to publish a note summarizing the method used by the company in preparing its Disclosure Report and identifying transfers of value for each category of spend relating to HCPs and HCOs (“Methodological Note”). This document represents Jazz/GW Pharmaceuticals Methodological Note for the reporting period 1st January 2021 to December 2021.
Jazz is committed to ensuring that transfers of value (ToVs) made to HCPs and HCOs are transparent. In making them transparent all reasonable efforts will go into making sure they are accurate, valid and complete.
Jazz complies with all laws, rules and regulations. Laws in the EU protect the rights of citizens in relation to the way their personal data is processed. HCPs (and HCOs in some member countries) are covered by Data Privacy laws and this affects the way in which Jazz can publish HCP and HCO ToVs. Jazz must seek permission (consent) from the HCP (or HCO if applicable) or have other legal reasons to individually publish their ToVs. Equally, confidentiality clauses within contracts with HCOs may prohibit Jazz from disclosing the ToV.
Where Jazz has been unable to obtain consent from an HCP (or HCO if applicable) that is fully compliant with General Data Protection Regulation (GDPR), or other legal reasons prevent Jazz from disclosing individually for an HCP or HCO, their ToVs have been added to an aggregate figure within the Disclosure Report. Please see the Reportable Transfers of Value (ToVs) to HCPs/HCOs section within this Methodological Note for more information.
Definitions
HCP:
The term health professional includes members of the medical, dental, pharmacy and nursing professions and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.
HCO:
The term healthcare organization means either a healthcare, medical or scientific association or organization such as a hospital, clinic, foundation, university or other teaching institution or learned society whose business address, place of incorporation or primary place of operation is in a country subject to the EFPIA Code.
Reportable Transfers of Value (ToVs) to HCPs/HCOs
Fees for Service and Consultancy:
Jazz engages HCP/HCOs for services when there is a genuine and legitimate business need and where the HCP/HCO is qualified and appropriate to provide the services. These services are paid with a Fee for Service at Fair Market Value.
These services can include:
- Speaker
- Training services
- Advisory board meetings
- Medical writing
- Data analysis
- Development of education materials
- General consulting/advising
- Congress symposia
- Retrospective non-interventional studies
- Participation in market research where such participation involves remuneration and/or travel. Payments for these services are only disclosed if Jazz is aware of the identity of those participating in the market research.
Donation and Grants:
Jazz provides support to medical or scientific education, advances in medical or scientific research, health or healthcare systems or disaster relief through financial or non-financial ToVs to legitimate, established organizations. Donations to HCOs can be both monetary and donations in kind.
Sponsorship Agreements:
Jazz gives contributions, through financial or non-financial support to legitimate, established organizations for medical or scientific education of external stakeholders, organizing or hosting educational or scientific events (including independent congresses).
Registration Fees:
As part of support to continuous medical education, Jazz provides support to HCOs or HCPs to cover the costs of registration fees for HCPs to attend selected independent congresses and where provided to HCOs, for other educational/scientific events.
Travel and Accommodation:
As part of support to continuous medical education, Jazz provides support to HCOs or HCPs to cover the costs for travel and accommodation for HCPs to attend selected independent congresses and/or Jazz-organized meetings and where provided to HCOs, for other educational/scientific events.
Research and Development:
All ToVs related to the planning or conduct of non-clinical studies, clinical trials and non-interventional studies performed by Jazz or by Clinical Research Organizations on behalf of Jazz, that are prospective in nature are considered Research & Development ToVs.
Inclusion and Criteria for Payments Disclosure
A Disclosure Report covers transfers of value from the 1st January to 31st December of the year of the report. The date on which the Jazz internal accounting system records the payment as having been made will determine within which annual Disclosure Report it is included.
The natural or legal person that holds the bank account to which the money is transferred is considered the recipient of the ToV and will be disclosed. Where a project requires transfers of value to be made in several instalments, the date on which the Jazz internal accounting system records the payment as having been made will determine within which Disclosure Report the transfer is included. This may mean that a ToV recorded in a Disclosure Report may be a part-payment, with other payments relating to the project being reported in other annual Disclosure Reports.
Indirect Payments:
Jazz may contract with third party agencies that go on to make ToVs to HCOs/HCPs. The end recipient (HCP/HCO) may not appear within the Jazz internal accounting system. Jazz makes the best effort to ensure that these ToVs made on our behalf are captured and reported as if they were made directly, by requesting information from the third party agencies with whom we work.
Cross-Border Activities:
Jazz employees are required to capture and report all ToVs to HCPs and HCOs with their primary practice in a country subject to the EFPIA Disclosure Code and/or other cross-border transparency reporting requirements. The country of disclosure will be determined by the address of principal practice for HCPs and the address of registration for an HCO.
Financial Data:
Disclosure will be made in local currency. For ToVs made in foreign currencies the Jazz exchange rate applicable at the time of the transaction is applicable.
VAT is included in the ToVs where required by the specific country regulations.
Consent Management
HCP Consent:
All efforts have been made to achieve a high level of individual HCP payment disclosure whilst recognizing the rights afforded to individuals under the General Data Protection Regulations (GDPR). Therefore consent has been sought from all individual HCPs to disclose individual ToVs. Where individuals have not consented or have withdrawn consent, this data is reported in aggregate.
Where an individual HCP has provided consent to disclose for some ToVs and not others, all ToVs for that individual are disclosed in aggregate. This is so as to ensure figures reported for individual HCPs are not misleading.