Amniotic membrane grafts

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

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.