Pharmaceutical products

Tender description

On 13 December 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 in the Republic of Ireland 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 January 2020). The HSE now wishes to communicate the outcome of this exercise to the marketplace. On 13 December 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 January 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’. The HSE received 477 requests from 24 suppliers resulting in 20 line items being amended and the removal of a further 56 line items. This updated version of the SSL is now available for download from www.etenders.gov.ie as 'Sole Source List v. 2020.1' or by emailing nppst@hse.ie. 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. The HSE intends to repeat this market engagement exercise on a regular basis (approximately every 6 months) 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 to the marketplace. 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 market engagement.