Проект «Системи покращеного доступу до лікарських засобів та фармацевтичних послуг» (SIAPS), що впроваджується MSH за фінансування USAID, оголошує конкурс з юридичної підтримки для впровадження Нацпереліку та Оцінки медичних технологій. Дедлайн - 22 листопада 2016 р. (далі англ.).

In 2014-2015, fulfilling USAID mandate, SIAPS developed a draft regulatory and legislative framework to establish an updated National Essential Medicines List (NEML) in line with modern requirements of European legislation. In 2016 MOH of Ukraine has approved new Regulations for EML, EML expert committee (EC) and essential medicines selection process.

It is expected that the new National Essential Medicines List will become the sole basis for public procurement in 2017 and that the list will also serve as the basis for reimbursement of outpatient medicines. However, the establishment of the legal framework and the EML Expert Committee are only two building blocks needed for the selection of medicines to the new EML and the future reimbursement formulary. The EML expert committee will become the national reference entity responsible for regular updates of the EML, and providing expert consultation for decision makers on procurement and reimbursement of essential medicines, based on HTA methods.

In regards to mentioned above SIAPS announces an open competition for the legal support of the new Essential Medicines List and HTA implementation.

The purpose of the assignment is

1.  To identify the legislative acts (in force and drafts) which regulate different lists of conditions and all medicines lists, as well as analyze them.

2.  To determine the status of these documents taking into account that the NEML will be the sole basis for public sector procurement and reimbursement.

3.  To draft legal documents for establishment of the NEML in Ukraine as a sole basis for public sector procurement and reimbursement.

4. To provide legal support to the EML EC and MoH on official approval of the NEML: develop internal regulatory documents.

5.  To develop a draft legal framework including terms of reference for the future establishment of an HTA Agency.

6.  To formalize HTA Guideline legally.

7.   To develop specifications for the above-listed tasks.

Deliverables:

A.  Task and deliverables specifications with identified list of legal documents for review and analysis;

B.  Report with conclusions and recommendations drawn from the analysis of the existing and draft legislation referred to in 1 above.

C.  Draft legal documents for the approval of the NEML.

D.  Draft legal framework for HTA agency establishment.

E.   Legally formalized Draft HTA Guideline.

Required qualifications:

1. Local legal firm with

2. At least 5 years of experience working in healthcare and pharmaceutical legislation;

3. Experience in drafting Ukrainian legislation based on international best practices;

4. Evidence of previously drafted regulatory documentation currently in use in the health care sector;

5. Experience in the development of regulatory and legislative documents to reform healthcare system especially with respect to the selection of medicines for procurement or reimbursement;

6. High level of English language proficiency.

For full information on the competition please see the document attached.

The deadline for quotes submission is November 22, 2016, 6 pm Kyiv time to [email protected].