OFFICIAL USE

TERMS OF REFERENCE

Advice on Regulatory Improvements in Ukraine’s Pharmaceutical Sector

1.Background

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 79at 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.

Industry regulation, however, has significant room for improvement, which could potentially spur further growth in pharma companies’ production and sales, and attract new investment, including that from EBRD.

While potential scope of regulatory changes is extensive, registration of pharmaceutical products has been singled out by market players as one of the most critical issues for normal functioning of the market. The process of registration is cumbersome, involves numerous iterations between experts and regulatory bodies, and results in unmotivated delays. Market participants called for reform, and discussions on the optimal procedures are underway currently. Furthermore, efficient (fast and reliable) drug registration process makes a country more attractive for the foreign direct investments (FDI) in pharmaceutical industry and particular in new manufacturing and R&D facilities for production and development of new drugs by the pharmaceutical companies.

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

The Ministry of Health (MoH) is asking EBRD 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, theAmerican 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”).

The task will be performed by independent consultants (the “Consultant”) to be retained by EBRD following a competitive selection procedure. The Ministry of Health of Ukraine is the beneficiary of the services to be provided by Consultant and will also review the shortlisted candidates and approve the final team of Consultant selected by the EBRD.

The Consultant will work in close co-operation with the experts and consultants of the EMA and WHO currently engaged in the TC assignment with the Ministry of Health and State Expert Centre, as well as the ACC, the APRaD, the EBA and local associations of pharma producers.The ACC’s Report “Vision 2020, Roadmap for development of the pharmaceutical sector in Ukraine”, which was produced and presented to the Ukrainian governmentin November 2014, will be provided to the Consultant and will serve as one of the key inputs for this assignment.

The Consultant will also ensure close liaison and consultation with experts performing a related/complementary study of the pharmaceutical framework by the EU Delegation in Kyiv, the World Bank, the World Health organisation and other international organisation with a view to ensure that the outcomes of these respective studies (in particular the recommendations for further action) are aligned.

2.EBRD’s role

The EBRD’s role is to support improvements to the national system of new drug approval,support Ukraine in its efforts to tackle the existing weaknesses in the registration framework and bring it closer to European registration requirements. As a result, Pharma companies will have an incentive to upgrade their own products and systems to meet these registration requirements, which are also expected to support the export of Ukrainian pharma products to other countries, including the European Union. As a results, pharma companies are expected to increase their investments which is expected to attractmore financing to the Ukrainian pharma industry from the foreign investors and banks including the EBRD.

3.Objective of the Assignment

The main objective of this assignment is to assist the The Ministry of Health of Ukraine to review the pharmaceutical registration procedures in Ukraine in order to identify and implement potential improvements, to bring registration process in compliance with the EU standards.

4. Scope of Work:

The proposed Project will be carried out in 4 phases:

Phase 1.Review the existing registration processes for pharmaceutical productsin Ukraine in details including the recent changes in the relevant legislation (the MOH’s Order # 460 in particular). The review should be done separately for the pharmaceutical products of chemical and biological origins (including biosimilars). Review a list of documents for submission, document flows and parties involved. Compare it with best EU practice and recommend measures to bring the registration processes in compliance with EU regulations aiming to (1) shorten processing time, (2) improve quality of expertise, (3) ensure alignment of drug registration and quality control proceduresand (4) eliminate opportunities for corruption (5) identify the needs to support the implementation of regulatory changes foreseen in the Decree # 426.

A special attention is to be devoted to the following:

  • Aligning pharmaceutical registration process and the GMP certification process for the medicine producers to avoid any possible overlapping.
  • Enhancement of cooperation between the registration expertise body (State Expert Centre) and the quality control body (the State Agency of Ukraine on Medicines) in relation to pharmaceutical registration process and outcoming registration documents.

Phase 2.Identify knowledge and expertise gaps in personnel of the Ministry of Health, State Expert Centre and/ or potentially – other bodies involved in the recommended drug registration process. Design and conduct necessary trainings[in cooperation with EMA and/or the EU].

Phase 3.Work out and assist in implementation of Institution building plan for the key regulatory/ expert bodies to be involved in the recommended registration process, aiming (1) to improve decision-making, (2) decrease personnel turnover, etc.

Phase 4.Design KPIs which would allow to follow implementation of the tasks outlined during Phases 1-3. Organise two meetings of Steering Committee 6 and 12 months after the recommendations have been handed to the Bank and the respective authorities to identify the pace and efficiency of implementation of the suggested improvements.

4.Tasks of the Consultant and deliverables:

To achieve the objectives of this assignment, the Consultant will undertake the following tasks and submit the following deliverables:

Phase 1 / Deliverables / Implementation period / Language of the deliverable
a)Analyse the existing registration processes for pharmaceutical products in Ukraine in details (separately for products of chemical and biological origins) including the recent changes in the relevant legislation the MOH’s Order # 460 in particular). Review a list of documents for submission, document flow and parties involved. Compare it with best EU practice and recommend measures to bringthe registration processes in compliance with EU regulations and aiming to (1) shorten processing time, (2) improve quality of expertise, 3) ensure a common approach to the registration process and out coming registration documents by both the state bodies involved in registration process and the state bodies involved in medicine quality control to eliminate any misinterpretations and confusionsand (4) eliminate opportunities for corruption. / Draft Registration process report / 6 weeks / English/Ukrainian
b)Discuss draft Registration process report with the Steering Committee, and collect its recommendations. / Collecting suggestions from the Steering Committee / 2 weeks / English/Ukrainian
c)Finalise Registration process report / Deliverable No 2: Final Registration process report presented to the Steering Committee / 2 weeks / English/Ukrainian
Phase 2
d)Identify missing knowledge, expertise and skills of the personnel responsible for expert review and registration of pharmaceuticals, identify gaps which prevent from the higher performance of the registration process on the whole, as recommended in task 2 a). Design training programs for personnel and conduct trainings with EMA/ EU involvement. / Deliverable No 3: Training plans presented to the Steering Committee, actual trainings delivered. / 8 weeks after submission of the Final Registration process report / English/Ukrainian
Phase 3
e)Prepare institutional capacity building plan for the institutions involved in pharma product registration, aiming to ensure (1) efficient decision-making; (2) necessary qualification of personnel and (3) mechanisms of personnel retaining. / Deliverable No 4: Institutional capacity building plan presented to the Steering Committee / 8 weeks after finishing Phase 2 trainings / English/Ukrainian
Phase 4
f)Define KPIs which would enable tracing the implementation of the suggested improvements. Conduct two Steering Committee meetings [6] and [12] months after handling Deliverables 1-4 to the Bank to evaluate progress on implementation of recommended improvements . Prepare two briefs for the Bank, and press-releases for general public based on these meetings. / Deliverables No 5 and 6: Evaluation reports, press-releases / [6] and [12] months after Deliverables 1-4 were handed to the Bank. / English/Ukrainian

5.Project implementation arrangements

The contracting authority for the Assignment will be the EBRD. Ministry of Health will be consulted during the selection process.The Project will be implemented under the supervision of the EBRD Operational Leader (“OL”).

For the “hands-on” coordination of the activities of the counterparts under the Project, a steering committee (the “Steering Committee”) shall be established immediately after the Project being launched, to include at least one representative of each of the Ministry of Health, the State Expert Centre, the ACC, the APRaD, the EBA, the EU Delegation in Kiev, association of local pharma producers and EBRD. Representatives of the largest pharma producers and distributors in Ukraine and other key stakeholders can be invited to attend the Steering Committee’s meetings. The Steering Committee shall discuss all recommendations as well as the Project’s implementation and progress reports prepared by the Consultant and submit the final proposals for approval to the relevant authorities.

The Consultant shall present a detailed plan of their work and calendar for the deliverables to the EBRD and the Steering Committee for approval at the Project’s inception (Deliverable no. 1)

6.Project time frame

The assignment is expected to start in March 2016. The time frame for this assignment is foreseen to be 19 months (including 7 months for Phases 1-3 and two Steering Committee meetings (Phase 4) 6 and 12 months after completion of the Phase 3).

7.Required qualifications of the Consultant

Corporate services are sought. The Consultant will be a firm or consortium 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 will include the following Key experts

  • Team Leader with knowledge of pharmaceutical industry, knowledge of the EU registration practice and regulations, and experience in managing policy dialogue projects.
  • International policy expert with proven experience in development and implementation of regulatory reforms in post-Soviet countries specialized in pharmaceutical industryand knowledge of the EU registration practice and regulations.
  • Local expert with extensive knowledge of Ukrainian regulatory policy and having record and understanding of the pharmaceutical sector and regulations development.

OFFICIAL USE