Re: Consultation on the Transposition of the new EU Procurement Directives

Transcription

1 Mr Paul Quinn Chief Procurement Officer Office of Government Procurement Bishop's Square Redmond's Hill Dublin 2 10 th December Re: Consultation on the Transposition of the new EU Procurement Directives Dear Paul, Enclosed please find the response to your public consultation on the transposition of the new EU Procurement Directives from the medical technology supply industry in Ireland. IMSTA, being the representative body for medical technology supply companies, has consulted widely within our industry and believe our response reflects the local perspective and is consistent with the positions of other national medtech trade associations such as Eucomed, the European representative body for medical technology companies. We appreciate the opportunity to engage with the OGP as the policy makers implementing the directive and would like to encourage OGP that the specificities of the medical device sector are reflected in the implementing legislation. Our position is summarised in the attached document. Yours sincerely, Justin Carty Chief Executive Officer

2 IMSTA, the representative body for medical technology supply industry in Ireland Transposition of the new EU Public Procurement Directives: Submission on Consultation Document December 2014

3 Having examined the new EU Directive on Public Procurement we found 6 major topics which are relevant to our industry: 1) Award of the Contract 2) Life-Cycle Costing 3) Tender Preparation 4) Flexible Procedures 5) E-Procurement 6) Centralized Procurement 1. Award of the contract We suggest a special regime for medical devices: price-only procurement and other measures including price caps, e-reverse auctions and others should be prohibited. When purchasing medical devices we recommend that MEAT (Most Economically Advantageous Tender) should be assessed based on a cost-effectiveness approach - such as Life-Cycle Costing (adjusted to medical devices) instead of price only - where quality criteria is linked to the life-cycle costing analysis based on environmental, social and technical aspects, linked to the subject-matter of the public contract. We may want to push for the following quality criteria to be taken into consideration: Long term economic and additional socio-economic benefits for patients Patient clinical outcome and quality of life Efficiency and cost gains of healthcare system Risk avoidance and re-hospitalization Proven increased productivity of healthcare provider Training, education and other after sale services Past performance: number of product recalls, supply performance Full regulatory and ethical compliance certificates 2. Life-cycle costing It should be considered that the generation of reliable life-cycle assessments (economic, social environmental) requires a notable effort in terms of manpower and financials. Consequently, the request of such information in mixed price/quality (MEAT) procurement activities should fulfill two basic conditions to be feasible for industry: 1. Same information to be used for any tender in the EU 2. Compensation of needed efforts to generate the requested information

4 3. Tender preparation We applaud to the new Directive awareness that early engagement with potential suppliers is a valuable tool to allow the industry to present public purchasers innovative products and services. As to the division of contracts into lots, we believe this is the best approach and, whenever this is not possible, a contracting authority should provide justification for the decision not to divide into lots. 4. Flexible procedures Our Industry welcomes these new rules (i.e. introduction of a new procedure called innovation partnership and some revision of traditional procedures) and agrees that for these procedures to be effectively used they need to be accompanied by adequate safeguards ensuring observance of the principles of equal treatment and transparency. 5. e-procurement Electronic catalogues could have potential for procurement of medical devices, provided that compliance with the principles of equal treatment, non-discrimination and transparency is ensured. Electronic auctions and most certainly electronic e-reverse auctions are not suitable for procurement of medical devices. 6. Centralized procurement We could expect procurement centralization to have a negative impact on innovation adoption due to weaknesses in the structure of procurement processes and/or contracts, i.e. excessive standardization with insufficiently specified demands, a dominant emphasis on purchase price vs. looking at cost of ownership, and the lock-out of alternatives during long contract periods. ADDITIONAL COMMENTS 1. Standard terms that set out clear parameters for each operator across all public sector contracts should be the norm. Economic/financial requirements should not necessarily override the technical and professional ability of the operator. If the economic requirements are aimed at the larger companies, smaller, newer SMEs will be precluded from submitting despite being able to offer what may be a

5 more flexible, technically proficient and long term, a more viable offering. SMEs, have had experiences of exclusion due to overly high financial parameters being set. Similarly, within the technical/professional ability, there should be scope to allow a degree of creativity to be offered within the parameters of the contract. Again, SMEs have experienced contracts not allowing for alternative offerings to be included in submissions, despite a long term saving being ultimately given to the public sector because the tender document had not allowed for it. 2. A regulatory requirement should/must be in place whereby any person/s involved in the tendering process of a contract must be asked to complete documentation that immediately highlights any conflict of interest so that the said person/s may be excused from the process. An administrative process, as proposed, would not be sufficient under these circumstances.