Amniotic membrane grafts

Tampere University Foundation sr (Tampere University, TAU) is about to execute a direct award procurement for 'Amniotic membrane grafts'. Tampere University Foundation sr (Tampere University, TAU) is about to execute a direct award procurement for 'Amniotic membrane grafts'.

CPV: 33000000 Medizinische Ausrüstungen, Arzneimittel und Körperpflegeprodukte
Ausführungsort:
Amniotic membrane grafts
Vergabestelle:
Tampere University Foundation sr
Vergabenummer:
TAU/4828/2023

1. Buyer

1.1 Buyer

Official name : Tampere University Foundation sr
Legal type of the buyer : Body governed by public law
Activity of the contracting authority : Education

2. Procedure

2.1 Procedure

Title : Amniotic membrane grafts
Description : Tampere University Foundation sr (Tampere University, TAU) is about to execute a direct award procurement for 'Amniotic membrane grafts'.
Procedure identifier : 2b614046-f24a-43f9-914f-b92fb779a932
Previous notice : 6eb733c8-6767-4e25-98c2-775e4ee8ad90-01
Internal identifier : TAU/4828/2023
Type of procedure : Negotiated without prior call for competition
Justification for the accelerated procedure :
Main features of the procedure :

2.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33000000 Medical equipments, pharmaceuticals and personal care products

2.1.2 Place of performance

Country subdivision (NUTS) : Pirkanmaa ( FI197 )
Country : Finland

2.1.4 General information

Legal basis :
Directive 2014/24/EU

5. Lot

5.1 Lot technical ID : LOT-0000

Title : Amniotic membrane grafts
Description : Tampere University Foundation sr (Tampere University, TAU) is about to execute a direct award procurement for 'Amniotic membrane grafts'.
Internal identifier : TAU/4828/2023

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33000000 Medical equipments, pharmaceuticals and personal care products

5.1.2 Place of performance

Country subdivision (NUTS) : Pirkanmaa ( FI197 )
Country : Finland
Additional information :

5.1.6 General information

Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.10 Award criteria

Criterion :
Type : Quality
Name : Quality
Description : Quality
Category of award weight criterion : Fixed value (total)
Award criterion number : 100
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : Markkinaoikeus -
Organisation whose budget is used to pay for the contract : Tampere University Foundation sr
Organisation executing the payment : Tampere University Foundation sr
Organisation signing the contract : Tampere University Foundation sr

6. Results

Value of all contracts awarded in this notice : 400 000 Euro
Direct award :
Justification for direct award : The contract can be provided only by a particular economic operator because of an absence of competition for technical reasons
Other justification : BACKGROUND INFO TAU Tampere University, Regea Tissue Center ( https://www.tuni.fi/en/about-us/regea-tissue-center ) is a clinical tissue bank. Regea has a tissue establishment (TE) authorization granted by Finnish competent authority Fimea. Regea procures and distributes tissue transplants (bone, tendon, amniotic membrane, and cornea) for clinical use. Regea also imports tissue transplants (sclera, amniotic membrane, pericardium) to Finland. Tissue transplants are used for treating a wide range of serious illnesses and injuries. Amniotic membrane is a placental membrane, which is procured during planned cesarean sections. It is used to treat eye injuries. It can be used as a graft or as a biological dressing to facilitate ocular surface reconstruction and to promote healing. Regea distributes two different amniotic membrane grafts: - frozen grafts in glycerol - dehydrated grafts Regea procures and prepares frozen amniotic membrane grafts itself. The dehydrated amniotic membrane grafts are purchased from another TE. The benefit of dehydrated amniotic membrane graft compared to frozen amniotic membrane graft is that it can be stored in the room temperature (no need for -80°C freezer in hospitals). It also has a wider list of potential indications since it can be used in an ambulatory setting with bandage contact lens or the same way as frozen amniotic membrane graft (in an operating theatre and attached with sutures or using tissue glue). NEED Regea has been distributing dehydrated amniotic membrane grafts since 2017. These grafts have been purchased from a non-Finnish TE. Finnish hospitals have found these dehydrated amniotic membrane grafts useful in many clinical indications and the amount of purchased grafts has been constantly increasing. The estimated purchases during the next four years will exceed the value of EU procurement threshold. However, noteworthy is that the amount of purchased grafts will solely depend on the future clinical need in Finland. Key characteristics for the dehydrated amniotic membrane grafts: - can be stored in room temperature - different disc sizes available, at least approximately 12 mm (the most common disc size used is 12mm in diameter) and 25 mm in diameter - accessible in an outpatient setting by ambulatory application - are clinically as efficient as currently used dehydrated amniotic membrane grafts - can be used for patients e.g. with: - Acute and chronic epithelial defects - Chemical and thermal burns - Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), Sjögren's syndrome, pemphigoid, ocular rosacea, graft rejection (GvHD)] - Keratitis - Corneal ulcers in connection with various procedures: pterygium, glaucoma, ocular neoplasm surgery MARKET ANALYSIS AND CONCLUSION FOR DIRECT AWARD The potential dehydrated amniotic membrane graft (disc) distributors were searched using appropriate search terms in English. The search was limited to English text due to the auditing responsibility (see legislation affecting the acquisition). It was presumed that companies not advertising in English would not have potential to provide their quality management documents in English for auditors. Legislation affecting the acquisition: - No. 101/2001 Act on the Medical Use of Human Organs, Tissues and Cells (Finnish law): Section 23a (778/2012) Import and export of tissues and cells Tissues and cells may only be imported to Finland and exported from Finland by a tissue establishment that has been granted authorization by the Finnish Medicines Agency. The cells/tissues to be imported or exported must comply with the requirements for quality, safety and traceability laid down in this Act. - Commission directive (EU) 2015/566 procedures for verifying standards. Import from Europe: Finland has implemented EU legislation thus importing from other EU countries is straightforward. Importing from U.K. is similarly straightforward since U.K. had implemented the EU legislation before Brexit. After Brexit there have been only minor changes in U.K. legislation, like coding of tissues (UK Tissue Establishments do not use Single European Code for labeling anymore). Based on the market analysis there is one other company in Europe providing amniotic membrane grafts that can be stored in room temperature, but the manufacturing method is not comparable, and the distributor provides two disc sizes, which are too large, considering the current need, thus limiting the usability in patient care. Import from outside Europe Based on the market analysis there might be some potential amniotic membrane graft providing companies in USA. Before importing Tampere University should audit the company for ensuring fulfillment of the set requirements in the commission directive (EU) 2015/566 and in the national law No. 101/2001. Auditing should be performed first before the acquisition decision. And after that there is a need for the monitoring of the company’s quality management and operations, the regulatory changes in the USA and the epidemiological situation in the USA. In addition, potential companies in the USA have listed several collaborating companies or tissue establishments around USA, thus making the auditing even more complicated . This would require much more resources than collaboration with a European TE. The auditing overall would easily outweigh financial gain if there were any. Conclusion: Due to the characteristics of the grafts, the graft sizes needed and the legislative requirements, only one specific supplier can be considered. The absence of competition is not due to an artificial narrowing of purchase conditions. The reason for direct award of the contract is that there is no other provider for a product with the required characteristics in Europe. The contracting authority has strict obligations and responsibilities as an authorized TE thus purchasing outside Europe would not be cost effective at the moment.

6.1 Result lot ldentifier : LOT-0000

At least one winner was chosen.

6.1.2 Information about winners

Winner :
Official name : NuVision Biotherapies Limited
Tender :
Tender identifier : NuvisionBT/ TAU/4828/2023
Identifier of lot or group of lots : LOT-0000
Subcontracting : No
Contract information :
Identifier of the contract : TAU/4828/2023
Title : Amniotic membrane grafts
Date on which the winner was chosen : 17/11/2023
Date of the conclusion of the contract : 28/06/2024
Organisation signing the contract : Tampere University Foundation sr

6.1.4 Statistical information

Received tenders or requests to participate :
Type of received submissions : Tenders from micro, small or medium tenderers
Number of tenders or requests to participate received : 1

8. Organisations

8.1 ORG-0001

Official name : Markkinaoikeus
Registration number : 3006157-6
Postal address : Radanrakentajantie 5
Town : Helsinki
Postcode : 00520
Country subdivision (NUTS) : Helsinki-Uusimaa ( FI1B1 )
Country : Finland
Telephone : +358 295643300
Roles of this organisation :
Review organisation

8.1 ORG-0002

Official name : NuVision Biotherapies Limited
Size of the economic operator : Micro, small, or medium
Registration number : GB222465234
Postal address : Thane Road, MediCity D6
Town : Nottingham
Postcode : NG90 6BH
Country subdivision (NUTS) : Nottingham ( UKF14 )
Country : United Kingdom
Telephone : +441157840120
Roles of this organisation :
Tenderer
Winner of these lots : LOT-0000

8.1 ORG-0003

Official name : Tampere University Foundation sr
Registration number : 2844561-8
Town : Tampere
Postcode : 33100
Country subdivision (NUTS) : Pirkanmaa ( FI197 )
Country : Finland
Contact point : Arto Heikkilä
Telephone : +358 2945211
Internet address : http://www.tuni.fi/en
Roles of this organisation :
Buyer
Organisation signing the contract
Organisation whose budget is used to pay for the contract
Organisation executing the payment

8.1 ORG-0004

Official name : Hansel Oy (Hilma)
Registration number : FI09880841
Postal address : Mannerheiminaukio 1a
Town : Helsinki
Postcode : 00100
Country subdivision (NUTS) : Helsinki-Uusimaa ( FI1B1 )
Country : Finland
Contact point : eSender
Telephone : 029 55 636 30
Roles of this organisation :
TED eSender

11. Notice information

11.1 Notice information

Notice identifier/version : bcaa7711-7998-488a-aa98-c6692125e9ca - 01
Form type : Result
Notice type : Contract or concession award notice – standard regime
Notice dispatch date : 26/05/2025 13:28 +00:00
Notice dispatch date (eSender) : 26/05/2025 13:28 +00:00
Languages in which this notice is officially available : English

11.2 Publication information

Notice publication number : 00345338-2025
OJ S issue number : 102/2025
Publication date : 28/05/2025