Sole Supply of Medicines to the HSE

Description

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 PMCand should do so by completing the attached response form (HSE 22316 Appendix 2 - Market Sounding 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 completing response form (HSE 22316 Appendix 5 – Response for medicine additions or updates) and reverting to the HSE via the eTenders messaging system. Failure to complete response form in full, will result in requests not being actioned. . 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 PMC. 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 PMC planned for Q3 2024. ** 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 sole 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 21048 Appendix 1 - Sole Source List' and attached to this notice. 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. 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 PMCand should do so by completing the attached response form (HSE 22316 Appendix 2 - Market Sounding 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 completing response form (HSE 22316 Appendix 5 – Response for medicine additions or updates) and reverting to the HSE via the eTenders messaging system. Failure to complete response form in full, will result in requests not being actioned. . 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 PMC. 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 PMC planned for Q3 2024. ** 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 sole 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 21048 Appendix 1 - Sole Source List' and attached to this notice. 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.