Janssen Sciences Ireland UC Disclosure Methodology for 2019

The information below describes the methodology that Janssen Sciences Ireland UC (Janssen) has applied to both the Janssen and Actelion data sets which will be submitted in one report to disclose the Transfers of Value (ToV) we have made to Healthcare Professionals and Healthcare Organisations for 2019.

In 2017, Actelion became part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Actelion, is an industry leader in the field of pulmonary hypertension (PH), and most notably, pulmonary arterial hypertension (PAH). Janssen has added PH as a therapy area of focus, to maintain and expand Actelion’s leadership position.

Actelion has since become part of the Janssen Sciences Ireland UC legal entity so all references to Janssen now include the Actelion business. Both Actelion and Janssen follow the same processes, aside for a few minor differences, at the time the 2019 data was collated. All such differences have been highlighted below.

The following types of payments to identified Healthcare Professionals (HCPs) (As defined in Clause 1.3) of the IPHA Code of Practice for the Pharmaceutical Industry.

1. Fee for service (FFS): Any payment made directly or indirectly via a third party acting on behalf of Janssen Ireland, to an individual for services provided by that individual which includes for example speaking or chairing an event on behalf of Janssen Ireland, participation at advisory board meetings and any other type of consultancy services.
2. Travel and accommodation costs related to FFS activity: Any travel or accommodation costs booked via Janssen or a third-party agent or an out of pocket expense claim processed to attend an event.
3. Sponsorship to attend an event: This includes registration fees, any travel or accommodation expenses booked via Janssen or a third party acting on behalf of Janssen, or an out of pocket expense claimed in relation to the attendance to the event.

The following types of payments to identified Healthcare Organisations (HCOs) (as defined in Annex 5 of the IPHA code of practice) are disclosed:

1. Donations and Grants. Donations grants and sponsorships to healthcare organisations.
2. Contributions to costs related to events through healthcare organisations or third parties, including sponsorship to healthcare professionals to attend events, such as:
   1. Registration Fees
   2. Sponsorship Agreements with healthcare organisations or with third parties appointed by a healthcare organisation to manage an event and
   3. Travel and accommodation
3. Fee for Service and Consultancy. Transfer of Value resulting from or related to contracts between companies and institution, organisations or associations of healthcare professionals under such institutions.

Medical Education Goods and Services supported by Janssen are included in the ToV report: These are the provision of goods and services that enhance patient care or benefit the healthcare system and maintain patient care which also include:

1. Donations
2. Grants
3. Benefits in kind

Please see “How does Janssen define Medical Educational Goods and Services?” and “How does Janssen report non-monetary ToV for Benefits in kind made to Healthcare Organisations (HCOs)?” for further details.

There is a further category for HCP ToV disclosures, whose identities cannot be disclosed for legal reasons (for example if they have refused consent to disclosure) and where Janssen has therefore disclosed ToV in this category on an aggregate basis. The aggregate disclosure includes the number of HCPs who have not given their consent for public disclosure, the percentage of HCPs who and the total amount paid. Please see “What is included in the aggregate disclosure section of the reporting template?” for further details.

Research and Development Transfer of Value within the meaning of Annex 5 of the Code have been disclosed on an aggregate basis.

The following rules apply:

• FFS costs to HCPs or, Donations, Grants and Sponsorships to HCOs and any other activities where a direct payment has been made, will be included in the calendar year in which Janssen executed the actual payment or reimbursement in our financial systems.
• ToV related to travel (e.g. flight tickets), accommodation (e.g. hotel room cost), registration fees and reimbursements for out of pocket costs, will be included in the calendar year during which the activity/meeting took place. Please note, the disclosure report may include some out of pocket costs which have been claimed in 2019 but are reported due to the event taking place late in 2018.
• In cases of payments through a third party acting on behalf of Janssen, our payment date to the third party is used as the determining factor to allocate the payment to the related calendar year.

Janssen is requesting consent from all HCPs before declaring a ToV against the individual concerned. If consent is withdrawn or not given the individual details will not be published and the ToV will be disclosed as an aggregate payment.

In 2019 due to a technical failure in our consent process for HCP’s who engaged in a FFS we have put all HCP’s who had a FFS with us to aggregate.

Detailed information on individual transfers of value can be accessed on a secure online portal provided to HCP’s by Janssen. Consent to disclosure can be provided or withdrawn at any time though the website or by contacting the ToV team directly.

As the disclosure of payments will be done on an annual basis consent or withdrawal of consent will apply to all transfers of value in a calendar year. HCOs cannot withdraw their consent for disclosure and therefore all ToV interactions are included.

In relation to Actelion, in 2019 consent was obtained on an agreement by agreement basis, so we are disclosing data from HCPs Actelion had disclosure consent for every activity undertaken. If consent is missing, or the HCP has chosen not to consent for disclosure of payment for a particular activity, all payments for that individual are disclosed in aggregate.

Janssen has excluded any payments made to patient organisations and charities for funding support requests for the organisation. Janssen is reporting payments made to patient organisations on our public website https://www.janssen.com/ireland/ and this will include a breakdown of the type of activities and payments made.

In relation to market research projects, Janssen will only disclose ToV to individuals where we know the identity of the individual consultant. For 2019 no such disclosures have taken place.

Janssen will not disclose individuals or organisations that have been contracted by third parties unless the third party has made Janssen aware of the individuals or organisation and their ToV. If known, Janssen has included these ToVs in the disclosure report.

Janssen has not disclosed any direct costs towards food and drink to individuals. However please note that some catering costs have been disclosed where costs for catering have been invoiced and charged for certain activities e.g. sponsorships with HCOs or breakfast costs with hotel room rates.

If a HCP performed a service or provided consultancy, the related cost of travel, accommodation arrangements provided and any reimbursement of out of pocket expenses as per the contract terms, are reported in the designated report section in the disclosure report (i.e. “Related expenses agreed in the fee for service or consultancy contract”).

If a HCP was unable to participate in an event or part of an event, only the costs that still constitute a true ToV to that HCP have been included in the disclosure report.

For example, if a HCP was only able to attend two of the three planned days of an event the accommodation costs for those two days will be reported. Costs of cancellation prior to the event are not reported, as they do not constitute a ToV to the HCP. Costs are also excluded from disclosure if a HCP, for whatever reason, is unable to attend an event, as there has not been any true ToV to that HCP.

Janssen has included the full hotel room rate as a cost for accommodation in the Disclosure report.

If a HCP contracts with Janssen through a private limited company and if any ToV is paid to the company in place of the HCP, Janssen will attribute the ToV to the individual HCP and not the private limited company. In the case of the individual deciding to withdraw consent, all payments instructed as above will be disclosed in the aggregate HCP section.

Any individual expenses, like travel & accommodation, will be reported and attributed to the HCP unless otherwise stated in the contract or if the individual withdraws consent these will be disclosed in the HCP aggregate section.

If an individual HCP has been paid indirectly for a FFS by Janssen, for example through a HCO or other third party sponsored by or acting on behalf of Janssen, Janssen has attributed the ToV to the individual HCPs when their details have been provided by the third party or HCO.

The HCP’s aggregate section of the Disclosure reporting template contains the total value per cost type that was transferred to HCPs who have chosen to opt-out of individual disclosure or where Janssen failed to obtain consent.

According to individual privacy rights, consent to individual disclosure can be withdrawn by HCPs, in which case disclosure is made on an anonymous aggregate basis. Janssen applies consent or withdrawal of consent per HCP for all ToV for a given calendar reporting year.

Individual HCPs can withdraw their consent via a secure website managed by Janssen or by contacting Janssen directly. Details on how HCPs can access this secure website have been provided to HCPs who have had a ToV with Janssen.

Research and Development (R&D) payments are also included in aggregate, within the R&D category. Please see “Research & Development (R&D) ToV reporting” for further details on what is included in R&D.

Janssen will report the most recent HCP or HCO address in their database at the time of reporting. If no current address is available within the database, Janssen will disclose the address that was written within the contract at the time when the ToV took place or registered for a given activity.

Janssen has disclosed Medical and Educational Goods and Services (MEGS), including donations, grants and benefits in kind to institutions, HCOs or associations that consist of HCPs and/or provide healthcare or conduct research. These are all documented by a contract and do not constitute an inducement to prescribe, supply, administer, recommend, buy or sell any medicine made by Janssen.

The disclosure of MEGS has been reported by the value that has been transferred either directly by a direct payment or indirectly by goods or services provided, where contracts are in place and payments or goods or services have been made or delivered in 2019.

The disclosure does not include MEGs that have been made between registered charities or patient organisations.

Janssen discloses benefits in kind as agreed using the fair market value as listed in the contract between Janssen and the HCO.

For contracts that span multiple years, typically a split payment approach is used. This means that the total value is transferred in separate payments over time.

Each of these separate payments will be included in Janssen disclosure numbers for the calendar year in which Janssen executed the actual payment or reimbursement in our financial systems.

The payments disclosed are the value received by the given HCO for the calendar year of 2019. If the contract spans over to the following year, the remaining value will be reported within the next disclosure reporting year (e.g. 2020 onwards).

Janssen has disclosed any sponsorship contribution made to a HCO or a third party to organise an event on behalf of a HCO, including costs for stand space rental and symposiums.

This may sometimes include catering costs where charged.

If a payment is requested by a HCO who has contracted a third party to manage an event on their behalf, Janssen has disclosed the ToV associated to the HCO irrespective of whether the payment is made to the HCO or to the third party.

Where Actelion has fully or partially sponsored a meeting organised by more than one HCO, the total payment amount has been divided by the number of organising HCOs and disclosed equally between each organising HCO.

All payments related to an individual HCP (e.g. FFS, consultancy, etc.) are reported exclusive of VAT unless charged by the individual through their private consultancy company.

All payments related to a HCO (e.g. Donations, Grants, Sponsorships, Fees for Service & Consultancy, are reported exclusive of VAT unless charged by the HCO.

All ToV for travel and accommodation (e.g. flight ticket, hotel room, etc.) are reported inclusive of VAT where applicable.

The disclosure reported ToV amounts should not be used for any VAT/Tax reporting purposes. If fiscal reports are required, the company provides them directly to the HCPs or HCOs.

All values reported are in Euro. For ToV that were originally paid in a different country, a conversion to local currency is made. Exchange rate details can be provided on a case by case basis.

Janssen is a member of the IPHA. Janssen has a code requirement to disclose all ToVs made to HCPs or HCOs based in Ireland by:

• Janssen Sciences Ireland UC or
• Any European Janssen foreign affiliate company. This includes any cross-border interactions with Janssen in Europe where payments have been made to Irish based HCPs or HCOs; these have been included in the Irish disclosure report.

ToV to any HCP/HCO of a Janssen company that is in scope of the EFPIA or IPHA disclosure code will be reported in their country of residence, regardless of which Janssen Company organized and/or made the TOV.

Johnson & Johnson Family of Consumer Companies and Johnson & Johnson family of Medical Device Companies are not part of Janssen and therefore are not included in the Janssen disclosure.

Research & Development (R&D) ToVs to HCPs or HCOs that have been disclosed in aggregate are related to the planning or conduct of:

1. Non-clinical studies (as defined in the OECD Principles of Good Laboratory Practice)
2. Clinical trials (as defined in Directive 2001/20/EC)
3. Non-interventional studies that are prospective in nature and involve the collection of data from, or on behalf of, individual or groups of health professionals specifically for the study.

Janssen has reported R&D ToV as one annual total amount for Ireland which included all the R&D TOV to HCPs/HCOs. This is aligned with IPHA’s disclosure requirements, and no individualised reporting for R&D TOV has been disclosed, unless the study was deemed non-interventional and retrospective in nature.

ToV by a distributor/sales intermediary NOT made on behalf of/at the direction of a Johnson & Johnson Company will be disclosed by the distributor/sales intermediary and not by the Johnson & Johnson Company.

In Ireland, details of ToV will be submitted by pharmaceutical companies and published on a central platform, accessible via the IPHA website. The Janssen https://www.janssen.com/ireland/ public website will host a link to where the information will be published.

Janssen relies on a combination of automated systems, standardised processes, and manual data entry from internal and external resources to record and report relevant ToV data. The information reported in this submission is done in good faith and best efforts to comply with the requirements of the IPHA Disclosure Code. Although Janssen strives for efficient and fast processing, it might occur that payment information becomes available only after the date of publishing. Should we, despite our best efforts to ensure accurate reporting, fail to include complete and correct information in our submission, we will appropriately investigate and address in case of erroneous information. Janssen expects this to be exceptional and will monitor actual occurrences. In case of significant changes to the initial publication (e.g. withdrawal of consent for individual disclosure) Janssen will publish an amendment within a reasonable timeframe. Should a HCP or HCO consider that the report is incomplete or incorrect, please contact us via [email protected] and we will endeavour to make appropriate changes.

The information on ToV is disclosed to IPHA to comply with the IPHA reporting requirements. The payments disclosed should not be used as backup for tax declarations or other purposes.