Are you ready to disclose?

All Transfers of Value (ToV) from 2015 must be disclosed publicly via the Irish Pharmaceutical Healthcare Association (IPHA) central reporting system by 1 July 2016. This relates to all ToVs that were made by pharmaceutical companies to Healthcare Providers (HCPs) and Healthcare Organisations (HCOs) in connection with the development and sale of prescription only medicinal products for human use. In addition, a company may choose to disclose ToVs on its own website.

Who does this apply to?

Disclosure obligations only apply to member companies (a "Company") (research-based pharmaceutical and consumer healthcare companies that manufacture and/or market proprietary medicinal products in Ireland/EU) of the IPHA or the European Federation of Pharmaceutical Industries and Associations (EFPIA). It also applies to companies who have voluntarily adopted the Disclosure Code 1. The Disclosure Code affects Companies in 33 European countries, including Ireland.   

What constitutes a ToV?

If a Company makes a donation or a grant to a HCO, or contributes to the cost of an event (sponsorship agreement (HCO only), registration fees, travel and accommodation) for a HCP/HCO, or pays fees for a service/consultancy, including related expenses to a HCP/HCO, then it must comply with the disclosure obligations. Direct and indirect ToVs must be disclosed. Direct transfers are those which are made directly by the Company for the benefit of the recipient, whereas indirect transfers are those that are made on behalf of the Company for the benefit of the recipient. 

Excluded ToVs

Over the counter medicines (OTCs)2 

Items of medical utility

Meals/drinks

Samples

Items in the ordinary course of sale and purchase

ToV between a member Company and a HCP from a non-EFPIA country, in a non-EFPIA country.

When does a ToV become disclosable?

A ToV becomes disclosable when a transfer occurs.  In other words, once a payment has actually been made by the Company to a HCP/HCO the obligation to disclose arises. However, in some instances where the HCP/HCO does not actually receive the benefit of the ToV, such may not need to be disclosed.

Disclosures will be made on an annual basis and the reporting period consists of a full calendar year.  The first reporting year is 2015, therefore any ToVs made prior to this will not be disclosed.  Disclosures must be made within six months after the end of the reporting period and should remain in the public domain for three years following such, unless a HCP's consent is withdrawn (under Data Protection law).

What you need to know as a Company

A Company must document all ToVs that it makes directly or indirectly to a HCP/HCO (including all ToVs in 2015).  Before these ToVs can be disclosed, consent must be obtained from a HCP/HCO.  It is recommended that consent be express and in written form.  A Company can obtain the consent of a HCP/HCO at the time of making a ToV and ideally consent should be incorporated into its contract with a HCP/HCO.  Pre-existing contracts should be reviewed to ensure that there are no restrictions on the disclosure of information.  HCPs and HCOs should be fully informed as to what information will be disclosed publicly, on what platform, when, for how long and that consent can be withdrawn (in the case of a HCP).

Where a HCP/HCO does not consent to the disclosure of his/her individual information, disclosure on an aggregate basis shall be made.

Disclosures need to be made in line with the national code of the country in which the HCP or HCO has their principal practice or physical address. For Ireland, a Company must use the EFPIA3 template in making the disclosures which must be submitted to the IPHA central reporting system prior to 1 July 2016.

What you need to know as a HCP

A Company should not disclose individual HCP information without his/her prior consent and knowledge.  HCP consent can be withdrawn in relation to individual disclosures at any time, however disclosure will still be made on an aggregate basis. Guidelines from the IPHA in relation to an acceptable timeframe for the removal of a HCP’s individual information, are expected shortly.  Where an aggregate disclosure is made, a HCP’s individual information can still be made available to authorities upon request.

What HCP information will be disclosed?

Disclosure on an individual basis includes: – full name; city of principal practice; country of principal practice; principal practice address; identifier registration number (optional); annual amount of: event registration fees/travel and accommodation; fee for service and consultancy; and related expenses. It is only necessary to disclose information applicable at the date of the transfer.

What you need to know as a HCO

It is recommended that HCOs review contracts that they have in place with a Company so as to ascertain whether or not the Company can in fact make a disclosure on an individual basis.  Prior notice to a HCO should be provided before disclosure, and consent should be sought by the Company to individual disclosure of information.  Where such a disclosure is not permitted under the HCO contract with a Company, or where consent is not provided, information will then be published in aggregate.  The right to withdraw consent under Data Protection law does not apply to HCOs, therefore a HCO should seek to negotiate such a clause in its contract with the Company.

What HCO information will be disclosed

Disclosure on an individual basis includes: – full name; city of registration; country of principal practice; principal practice address; annual amount of: donations and grants, sponsorship agreements, registration fees, travel and accommodation; fee for service and consultancy; and related expenses. Only information at the date of transfer need be disclosed.

The central reporting system will go live to the public on 1 July 2016.

For more information please contact Cliona Christle or Róise NicGhráinne at A&L Goodbody.

1. The Disclosure Code at Annex V of IPHA Code of Practice for the Pharmaceutical Industry, Version 8.1 (adopts the EFPIA Code on Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations).

2. If OTCs are also available by prescription (e.g. reimbursement condition) then ToVs relating to such OTCs are disclosable.

3. The EFPIA template is available at the back of the Disclosure Code. A methodology note must accompany the template.