Public procurement notice: Prior Information Notice Without Call For Competition
Published: 2019-12-17
Buyer: Health Service Executive (HSE)
Country: IE
Contract type: Supplies
CPV classification: 33600000: Pharmaceutical products | 33680000 | 33711540

Technical requirements: Market engagement: the HSE wishes to establish a list of authorised medicinal products which are marketed in the Republic of Ireland 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. 24/01/2020).
The HSE intends to establish a dynamic purchasing system (the ‘DPS’) in Q1 2020 to facilitate the participating bodies listed in ‘Appendix 3 — Participating Bodies’ (which, for the avoidance of doubt, includes the HSE) in procuring their requirements for authorised medicinal products in a manner that is compliant with procurement legislation.
For the purpose of this prior information notice (PIN), all of the participating bodies shall be referred to as ‘HSE’.
For the purpose of this PIN, the HSE has compiled, based on the best available data, a list of medicinal products, authorised for marketing in the Republic of Ireland and currently purchased throughout the HSE, which are only commercially available from a single source in the Republic of Ireland. This compilation is available for download on www.etenders.gov.ie as ‘Appendix 1 — Sole Source List’ (hereafter ‘SSL’). The SSL includes details of the marketing authorisation holder for each medicinal product. For the purposes of this list, an authorised medicinal product should be construed as the combination of ‘Active Substance’ (rINN — Recommended International non-proprietary name), ‘Form’ and ‘Strength’.
As 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:
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 (Appendix 2) 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. It is intended that future contracts for the supply of any such authorised medicinal products removed from the SSL shall be procured following a mini-competition pursuant to the aforementioned DPS once it has been established.
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 nppst@hse.ie 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 Q3 2020.
All completed response documents should be submitted via the eTenders messaging system no later than noon on 24.1.2020.
This PIN is issued solely for the purpose of conducting a market engagement exercise and does not constitute any commitment by the HSE to undertake any public procurement exercise in the future.
The Sole Source List is independent of the reimbursement process for medicines in the Republic of Ireland.
The HSE gives no warranty or representation as to the accuracy or completeness of the information provided and shall not be liable for any errors or omissions.
The HSE is not liable for any costs, fees or expenses incurred by any party participating in this market engagement exercise.
The HSE cannot guarantee it will incorporate all or any feedback received into any subsequent procurement.