Prior Information Notice for the supply of Sole Source Medicines to the HSE

* Market engagement: The HSE wishes to establish a list of authorised medicinal products which are marketed and which are only commercially available from a single source in the Republic of Ireland, as of the date for return of responses to this PIN (i.e. 01/12/2021).

** On 13/12/2019, the HSE published a Prior Information Notice (PIN) (OJEU ref: 2019/S 243-596458) seeking to establish a list of authorised medicinal products which are marketed and are only commercially available from a single source in the Republic of Ireland, as of the date for return of responses to the PIN (i.e. 24/01/2020). The HSE published the outcome of this process on 7th September 2020 (OJEU ref:2020/S 177-424875).

As part of the ongoing additions and amendments to this list, the HSE now wishes to communicate the updated outcome of this exercise to the marketplace, please refer to the document attached HSE 17559 Appendix 1 - Sole Source List.

* If any supplier considers itself to be a supplier of an alternative product to that included as a line item on the SSL, the supplier is requested to respond to this PIN and should do so by completing the attached response form (HSE 17559 Appendix 2 - PIN Response Form) and reverting to the HSE via the eTenders messaging system.

In the event that the marketplace reasonably demonstrates that any of the authorised medicinal products in the SSL can be commercially provided in the Republic of Ireland by an alternative supplier to that listed on the SSL, then that authorised medicinal product shall be removed from the SSL.

The HSE considers that in the event the marketplace does not reasonably demonstrate that any of the authorised medicinal products in the SSL can be commercially provided by an alternative source in the Republic of Ireland, then the HSE may reasonably conclude that the exemptions available under Article 32 2 (b) may be employed for the procurement of such authorised medicinal products listed on the SSL.

Suppliers who wish to inform the HSE of an authorised medicinal product which is marketed in the Republic of Ireland by a single source and has not been listed on the SSL should do so by emailing [email protected]. For the avoidance of doubt the HSE does not intend to employ Article 32 2 (b) for single source authorised medicinal products newly identified through this PIN. However, subject to verification by the HSE, any newly identified authorised medicinal products shall be included on the SSL for the next authorised medicinal products market engagement PIN planned for Q2 2022.

** On 13/12/2019, the HSE published a PIN (OJEU ref: 2019/S 243-596458) seeking to establish a list of authorised medicinal products which were marketed in the Republic of Ireland and were only commercially available from a single source in the Republic of Ireland, as of the date for return of responses to the PIN (i.e. 24/01/2020).

The HSE compiled, based on the best available data, a list of medicinal products, authorised for marketing in the Republic of Ireland and purchased throughout the HSE, which were only commercially available from a single source in the Republic of Ireland. This compilation (the 'Sole Source List', hereafter 'SSL’) was made available for download and market operators were invited to respond.

The SSL included details of the marketing authorisation holder for each medicinal product. For the purposes of this list, an authorised medicinal product was to be construed as the combination of ‘Active Substance (rINN — Recommended International non-proprietary name)’, ‘Form’ and ‘Strength’.

This updated version of the SSL is now available for download from www.etenders.gov.ie as 'HSE 17559 Appendix 1 - Sole Source List' and attached to this notice or by emailing [email protected]

Having undertaken this thorough market engagement exercise, the HSE believes that each of the line items on the SSL can only be provided by a single source, the HSE intends to employ the exemptions provided under Article 32 Paragraph 2 (b) of the European Directive 2014/24/EU to use the ‘Negotiated procedure without prior publication of a tender notice’. The use of this procedure is justified where the, supplies can only be provided by a particular economic operator for any of the following reasons:

(ii) competition is absent for technical reasons;

(iii) the protection of exclusive rights, including intellectual property rights.

As per the original publication, the HSE is repeating this market engagement exercise on a regular basis to update the SSL with the current version of the SSL being utilised until the next market engagement exercise has been completed and the outcome communicated.

The authorised medicinal products, suggested by suppliers as being marketed in the Republic of Ireland by a single source and were not included on the previous SSL, will be reviewed by the HSE with the intention of including them in the next engagement.

The purpose of this PIN is to:

* Notify the wider market that the HSE does not intend to subsequently publish a contract notice but instead will utilise a negotiated procedure without prior publication to secure its requirement for any line item on the SSL.

** Notify the market of updated to the SSL.