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Nuclear Safety Cooperation

L-Thyroxine Tablet Foaming & Packing Fac

Status
Closed
All Countries
Benefitting Zone
Worldwide
€ 81,013.52
EU Contribution
Contracted in 1996
TACIS
Programme
Technical Assistance to the Commonwealth of Independent States

Details

Type of activity

Mitigation of Chernobyl accident

Nature

Services

Contracting authority

European Commission

Method of Procurement

Direct Agreement & AV DA

Duration

26/08/1996 - 26/08/1998

Contractor

FICHTNER GMBH & CO KG

Project / Budget year

WW9305 Inter States / 1993

Background

Following a request from the Belarusian, Russian and Ukrainian authorities, the European Commission established the Chernobyl Regional Programme as a part of the TACIS 1993 Nuclear Safety Programme. The programme was intended to assist those countries in dealing with the consequences of the Chernobyl accident.
The programme began with a rapid exercise to assess the needs of the three countries, identify actions already undertaken and define the key priorities for funding by the EC and other donors.
It was initially anticipated that first efforts would concentrate on actions to limit the consequences of soil contamination, but, subject to initial assessment, other actions dealing with the social and economic problems resulting from the Chernobyl accident could also be included. One of these actions was to provide for an improvement in the treatment of thyroid cancer in the populations in the affected countries.
One of the principal aids in managing thyroid cancer and treating other thyroid problems is L-Thyroxine, a replacement for the hormones naturally produced by the thyroid gland. As at May 1994 this was not produced in the Chernobyl affected regions meaning that the required supplies had to be imported.
It was estimated at the time that in Ukraine there were about 40,000 patients for whom L-Thyroxine was prescribed. The resulting overall requirement for L-Thyroxine was estimated at 55 million x 100 microgram tablets per annum. This gave rise to a significant importation cost in 1994 of about $650,000 per annum. The requirements in Belarus were about the same. Russian requirements were not considered under this project as it had been reported that a manufacturing facility was under construction in the country.
Consequently, a project was programmed under the TACIS 1993 Chernobyl regional programme for the design and installation of facilities, at the Borschahiwska Pharmaceutical Factory of the FARMAK Joint Stock Company in Ukraine, for the forming and packaging of L-Thyroxine tablets and subsequent storage and distribution of the drug for the Chernobyl affected regions.
The Terms of Reference for the project had been prepared under a previous contract (see 22782).
A conceptual design study was undertaken by Fichtner (see contract 23214). A general concept for the L-Thyroxine tablet production facility was developed and Technical Specifications were prepared for the procurement of the equipment to be financed through the TACIS programme, comprising:

Technical equipment for the manufacturing, tableting and packaging of the L-Thyroxine tablets;

Interior equipment, heating, ventilation and air-conditioning for the facility premises.
The equipment was purchased through a separate supply contract (see project U5.09/93).

Objectives

The aim of the present project was to provide technical consulting services for the tendering and procurement of the equipment described above for the Borschahiwska Pharmaceutical Factory. The manufacture and delivery of the equipment itself was part of a separate project (see project U5.09/93).
The work to be performed included:

Preparation and launch of the tender

Preparation of responses to tender clarification requests from tenderers

Organisation of the tender evaluation and preparation of the evaluation report

Provision of technical support during contract negotiations and preparation of contracts

Follow-up of equipment supply contract implementation

Organising the kick-off meeting with all parties involved

Supervising and coordinating the implementation of all activities until the setting into operation of the plant in accordance with the contractual terms and the envisaged timetable

Performing acceptance checks in the workshops of the equipment suppliers before shipment

Checking completeness of shipments and deliveries, as well as services of the Beneficiary and the End User

Organising final acceptance tests in order to prove that the plant fulfils the required functionality and performance requirements

After the commissioning of the plant, establish the necessary acceptance certificates (provisional and final) and ensure that they are fully signed by the required parties

Results

The tasks were performed as described above. The tender evaluation took place in November 1996 in Brussels. Contract negotiations took place in December 1996 and the contract was eventually placed for the equipment supply in August 1997.
The tasks of the Consultant during the equipment manufacture, delivery installation and testing were performed in accordance with the contract requirements.