Advice on Regulatory Improvements in Ukraine's Pharmaceutical Sector



Business sector:


Funding source:

Not Yet Determined

Contract type:

Consultancy Services

Notice type:

Invitation for expressions of interest (CSU)

Issue date:

10 Feb 2016

Closing date:

07 Mar 2016   at  23:59   London

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Project Description

Ukraine’s pharmaceutical market is one of the fastest growing in the country, having posted solid 5Y CAGR of 14% in 2008-13. Despite rapid growth levels, the market is not yet saturated, as per capita expenditures for pharmaceutical products in Ukraine remained at EUR 79 at its historical peak in 2013, 23% of that in the EU-25 in 2012, according to OECD Health data. Local pharma producers are very robust to the economic downturns, as at times of falling purchasing power, population turns to Ukraine-made cheap generics.

Having signed the Association Agreement with the EU, Ukraine committed itself to “achieving economic integration, inter alia …. through extensive regulatory approximation”. This includes, among others, gradual adjustment of regulatory environment at Ukraine’s pharmaceutical market with the EU Directives. Although Ukraine have made significant steps towards the harmonisation of the drug registration process with EU, there are still areas for improvement.

The Ministry of Health (MoH) has requested the European Bank for Reconstruction and Development (the “EBRD” or the “Bank”) to launch a policy dialogue effort in close cooperation with the industry, European Medicines Agency (EMA) and World Health Organisation (WHO), the EU Delegation in Kyiv, the American Chamber of Commerce (ACC), European Business Association (EBA) and the relevant governmental bodies aiming to improve pharmaceutical registration procedures to bring them in compliance with the EU standards (the “Project”).

Assignment Description

The EBRD intends to engage a consultant to assist the Ministry of Health of Ukraine to review the pharmaceutical registration procedures in Ukraine in order to identify and implement potential improvements and to bring registration process in compliance with the EU standards (the “Assignment”).

The assignment will be conducted in four phases as described in the Terms of Reference.

Status of Selection Process: Interested firms or groups of firms are hereby invited to submit expressions of interest.

Assignment Start Date and Duration: The Assignment is expected to start in March 2016 and has an estimated overall duration of 19 months.

Maximum Cost Estimate for the Assignment: EUR 295,000.00 (exclusive of VAT).

The Consultant must determine whether any VAT would be chargeable on the services and the basis for that determination, without taking into consideration the special status of the Bank as an IFI and state this to the Bank in their response to the Invitation for Expressions of Interest. To the extent that a Consultant incurs input VAT on goods and services purchased in connection with the provision of services (e.g. VAT on airline ticket) which is not otherwise recoverable by the consultant from the local tax authority, the gross cost to the consultant of such expenses shall be treated as a reimbursable expense.

Funding Source: The Assignment will be funded from Technical Cooperation funds managed by EBRD.

Eligibility: There are no eligibility restrictions.

Consultant Profile: Corporate services are required. The Consultant will be a firm or a group of firms with proven experience in development and implementation of efficient drug registration process, as well as knowledge of the EU and Ukrainian pharmaceutical legislation. The Consultant’s team of experts is expected to include the following key experts:

a) Key Expert No 1 Team Leader with knowledge of pharmaceutical industry, knowledge of the EU registration practice and regulations, and experience in managing policy dialogue projects;

b) Key Expert No 2 International policy expert with proven experience in development and implementation of regulatory reforms in post-Soviet countries specialized in pharmaceutical industry and knowledge of the EU registration practice and regulations;

c) Key Expert No 3 Local expert with extensive knowledge of Ukrainian regulatory policy and having record and understanding of the pharmaceutical sector and regulations development.

Submission Requirements: In order to determine the capability and experience of Consultants seeking to be selected for this Assignment, the information submitted should include the following:

1. Company/group of firms’ profile, organisation and staffing (max. 2-4 pages).

2. Details of previous project experience or similar assignments particularly undertaken in the previous five years, including information on contract value, contracting entity/client, project location/country, duration (mm/yy to mm/yy), expert months provided (if different from duration) , main activities, objectives.

3. CVs of key experts who could carry out the Assignment detailing qualifications, experience in similar assignments, particularly assignments undertaken in the previous five years, including information on contracting entity/client, project location/country, duration (mm/yy to mm/yy), expert months provided, assignment budget, main activities, objectives.

4. Suggested methodology for this Assignment, including approach to its implementation.

5. Completed Consultant Declaration Form and Contact Sheet, the template for which is available from the following web-link:

Failure to submit the signed Consultant Declaration may result in disqualification of the candidate from the selection for this Assignment.

The above information should not exceed 25 pages excluding CVs and contact sheet.

The complete expression of interest (including CVs, Consultant Declaration and Contact Sheet) should be submitted, in English electronically through e-Selection, to reach the Bank not later than the closing date referred to above. The expression of interest shall be one file (pdf). The EBRD reserves the right to reject applications of firms submitting more than one file. Only if the permissible file size is exceeded (4MB), the Consultant may split the expression of interest into further files.

Bank Contact Person:

Larissa Gosling

Technical Co-operation

European Bank for Reconstruction and Development

One Exchange Square

London EC2A 2JN

Tel: + 44 207 338 6338


(submissions should be sent through eSelection and NOT to this email address)


1. The selection will normally be made from responses to this notification only. Consultants will not be asked to submit a proposal. The highest-ranked Consultant will be selected from a shortlist and be invited to negotiate the contract, subject to availability of funding.

2. The shortlist criteria are:

(a) Firm’s international experience in development and implementation of efficient drug registration process, and demonstrable knowledge of the EU pharmaceutical legislation - 40%

(b) Firm’s proposed methodology and approach to the assignment - 20%

(c) CVs of Key Experts as per requirements indicated above - 40%