Strengthening the Transplant Agency of the Republic of Moldova

and support in legal approximation in the area of quality and safety of substances of human origin

Programme: National Action Programme 2010

Partner Country: Moldova

Area of Cooperation: Consumer and Health Protection

STANDARD TWINNING PROJECT FICHE

"Strengthening the Transplant Agency of the Republic of Moldova and support in legal approximation in the area of quality and safety of substances of human origin"

1,200,000.00 EUR

MD10/ENP-PCA/HE/11

List of Abbreviations

AA

/ Association Agreement

AP

/ Action Plan
ART / Assisted Reproduction Technology
BC / Beneficiary country
CA / Competent Authorities
CoE / Council of Europe
DCFTA / Deep and Comprehensive Free Trade Area
DRG / Disease Related Groups
DUE / The European Union Delegation
EaP / Eastern Partnership
EC / European Commission
ECHR / European Convention on Human Rights
ENP / European Neighbourhood Policy
ESRD / End Stage Renal Disease
EU / European Union
GD / Government Decision
HBD / Heart Beating Donors
HLA / Human Leucocyte Antigen
HPC / Human Progenitor Cells
IOM / International Organization for Migration
IMSP / Public Medical Institution
MoE / Ministry of Education
MoF / Ministry of Finance
MoH / Ministry of Health
MoIA / Ministry of Internal Affairs
MoITC / Ministry of Information Technologies and Communication
MoJ / Ministry of Justice
MoLSPF / Ministry of Labour, Social Protection and Family
MS / MemberState
NAP / National Action Plans
NGO / Non Governmental Institutions
NHBD / Non-Heart Beating Donor
NHIC / National Health Insurance Company
OSCE / Organisation for Security and Cooperation in Europe
PAO / Programme Administration Office
PCA / Partnership and Cooperation Agreement
PL / Project Leader
QMS / Quality Management System
RM / Republic of Moldova
RTA / Resident Twinning Advisor
SOP / Standard Operational Procedure
TA / Transplant Agency
TACIS / Initiative for Eastern Europe, the Caucasus and Central Asia
TAIEX / Technical Assistance and Information Exchange Programme
TWG / Twinning
UNDP / United Nations Development Program
WHO / World Health Organization

STANDARD TWINNING PROJECT FICHE

1Basic Information

1.1 Programme:National Action Programme 2010

1.2Twinning Number:MD10/ENP-PCA/HE/11

1.3Title:Strengthening the Transplant Agency of the Republic of Moldova and support in legal approximation in the area of quality and safety of substances of human origin

1.4Sector: Consumer and Health Protection (HE)

1.5Beneficiary country:Republic of Moldova

2Objectives

2.1Overall Objectives

To contribute to a betterquality and safety of transplantsof human organs, tissues, and cells in the Republic of Moldova.

2.2Project purpose

To develop the transplant system in the Republic of Moldova and to strengthen the Transplant Agency by:

-Improving the institutional and legal framework and the quality standards,

-Increasing knowledge, skills and practice, and ethics of the human resource.

2.3 Contribution to Partnership and Co-operation Agreement and the European Neighbourhood Policy Action Plan

The Partnership and Cooperation Agreement (1998) and the EU-Moldova European Neighbourhood Policy Action Plan (2005) presently guide the relationships between the European Union (EU) and the Republic of Moldova (hereafter referred as Moldova).

The Eastern Partnership (EaP), launched by the European Commission in May 2009, builds upon these Agreements and is designed to deepen bilateral relationships with partner countries, through enhanced political association and closer economic integration. In this context, the EaP envisages the establishment of new contractual relations in the form of an Association Agreement (AA).

The European Neighborhood Policy (ENP) opens new partnership perspectives, among which “Support including technical assistance and twinning to meet EU norms and standards, and targeted advice and support for legislative approximation through a mechanism such as TAIEX”. To this end, twinningoperations will be implemented, establishing direct cooperation between EU and Moldovan public bodies to implement institution-building projects with mandatory results to the benefit of Moldova.

The EU/Moldova Action Plan includes the following priorities:

Priority 5: Develop and implement an appropriate legal framework for the prevention of, and the fight against, the trafficking in human beings, and for addressing the problems faced by victims of trafficking:

- Revision of anti-trafficking law, including the relevant elements of the new criminal and criminal procedure codes, to bring it fully in line with international human rights standards;

- Enhance cooperation in the framework of relevant international organisations (OSCE, UN) on this issue;

- Ratify relevant international instruments, such as the UN convention against transnational organised crime (“Palermo convention”) and its Protocol to prevent, suppress and punish trafficking in persons, especially women and children.

Priority 51: Ratification and full implementation of international instruments, which are of particular importance in combating organised crime:

- Ratify UN Convention against Trans-national Organised Crime and its protocols on smuggling of migrants and trafficking in persons and adopt and implement national legislation (including human right aspects) accordingly.

Priority 80: Increase the level of health security and epidemiological safety in Moldova in line with EU legislation and in cooperation and with the support of the WHO. Relate the information system of Moldova to the health indicators process underway in the EU:

- Reform of health system.

3Description

3.1Background and justification

The transplantation of human organs, tissues and cells is a strongly expanding field of medicine offering great opportunities for the treatment of as yet incurable diseases. The quality and safety of these substances should be ensured. In the area of tissue, cells and organ procurement for transplantation there are two main types of organizations: tissue establishments and organ transplantation centres.

In the Republic ofMoldova, the transplantation activities began with tissue transplants in 1960. Organ transplantationinthe Republic ofMoldovahad its beginningwith entering intoforce of theorder of the USSR Ministryof Health Nr.153 from 22 February 1982on“The right ofkidney procurementand preservation fortransplant”. The first cadaveric kidney transplant from non-heart beating donors (NHBD) was on June 1982.

Kidney transplantationactivity in the period 1982-1999 was as follows:

- Kidney retrievalfrom NHBD: 196 cases;

- Kidney transplants: 242 cases.

The Law Nr.473-XIVon “Human organs and tissues transplantation” was adoptedon 25 June 1999.

The Kidney Transplantation activity in the period 2000-2008 was as follows:

-Kidney transplantation with kidneys from HBD: 6 cases;

-Kidney retrievals from living related donors: 15 cases.

The reported problems of the transplant service in the Republic of Moldova during this period were numerous and serious:

-Insufficient knowledge of transplant legislation by the majority of state institutions, medical opinion, citizens, church, etc.;

-Absence of an organ transplantation program approved by the Government, MoH and Medical Institutions implicated in transplant activities;

-Poor financial supply of the Transplantation development in the Republic of Moldova;

-Negative mass-media image of transplant service in post-soviet countries (Russia, Ukraine and Moldova);

-Illegal organs (kidney) and international traffic from living donors influence upon the development of transplantation in the Republic of Moldova.

Within the Joint Programme of the European Commission and the Council of Europe to support democratic reforms in Moldova for 2004-2006, Council of Europe experts organized several seminars and workshops coming up with several suggestions, including changing the law on transplantation of organs, tissues and cells of human origin and establishment of a Transplant Agency (TA). As a result of these efforts the Law Nr. 42 onthe transplant of human organs, tissues and cells was developed and adopted by the Parliament of the Republic of Moldova on March 6, 2008. According to the new legislation, the Transplant Agency was created as a public body under the MoHbyGovernment DecisionNr. 386 on May 14,2010.

A more recent evaluation (2010-2011) of the legal and institutional developments in the area of transplantation in Moldova is available as part of the UNDP reports - UNDP Project “Building Institutional Capacity of the Ministry of Foreign Affairs and European Integration”, provided by consultants A. Cucu and A. Pavlou.

3.1.1Framework and Context

3.1.1.1 Institutional framework of the Transplant system

-The Transplant Agency (TA):

The Transplant Agency (TA) is subordinated to the MoH, according to the Law Nr. 42-XVI from 06.03.2008on the transplant of human organs, tissues and cellsand HG Nr. 386 from 14.05.2010 regarding the establishment of the TA. The MoH is the policy maker in the area. The implementation of the transplant policy is entrusted to the TA, which is an institution of the MoH. The TA has a designated budgetary line in the State Budget, to ensure its financial autonomy.

The TA has the following declared aims and objectives:

-Drafting of the consecutive legal framework derived from Law Nr. 42-XVI / 06/03.2008 on the transplant of human organs, tissues and cells;

-Drafting of the consecutive legal framework derived from Law Nr. 185-XV / 24/05.2001 on medical fertilization and family planning;

-To evaluate and authorize(the MoH is authorizing the institutions and teams upon the TA proposal) medical units for transplant activities – i.e.: a) organ / tissue / cells procurement, b) organ / tissue / cells transplantation, c) bank tissues / cells;

-To organize and supervise the entire transplantation activity in the RM;

-To evaluate the current situation / activities in the field of transplantation in the RM;

-To correctly inform the public opinion and to promote transplant donation;

-To organize international cooperation with transplant agencies from neighbor and EU countries.

The TA employed (GD Nr. 386 / 14.05.2010) 12.25 equivalent-persons out of a maximum approved 15.5 (5.75 doctors, 2 nurses and 4.5 support staff - accountant, legal department, etc.).

Overall there are 6 permanent staff and 6 part-time; 6.75 equivalent-persons have a university degree.

All medical staff has been specialized mostly in EU transplant centers and some in public health policies through continuous Medical Education (The current organogram of the TA is presented in Annex 4).

-The structure of the transplantation system:

The structure of the transplantation systemincludes:

  1. The Transplant Agency (TA);
  2. Ten accredited(authorized) transplant centers (MoH order No. 527 / 27.06.2011; MoH order No.156 / 24.02.2012); the list of currently existing establishments is as follows:
  3. IMSP Republican Clinical Hospital,
  4. IMSP National Scientific-Practical Centre for Emergency Medicine,
  5. IMSP Neurology and Neurosurgery Institute,
  6. IMSP OncologyInstitute,
  7. IMSP “Sfânta Treime” Municipal Clinical Hospital,
  8. IMSP Orthopaedic and Traumatology Clinical Hospital,
  9. IMSP Forensic Medicine Centre,
  10. IMSP “Emilian Cotara” Republican Clinical Hospital for Children,
  11. “V. Ignatenco” Municipal Clinical Hospital for Children,
  12. Scientific Research Institute in the field of Mother and Child’s Health Care,
  13. Included in the IMSP Orthopaedic and Traumatology Clinical Hospital, the Laboratory for tissue procurement and preservation - as a core for the Bank of Human Tissues and Cells (as per 17.10.2011);
  14. 8transplant coordinators(doctors),
  15. 5 doctors responsible for organ transplantation,
  16. 8 doctors responsible for tissue transplantation,
  17. 4 nurses responsible for transplant activities;
  18. The integrated informatics system for transplant management and organ allocation - SIA “TRANSPLANT”;
  19. HLA/immuno-typing laboratory;
  20. ART.

-System in place in the Republic of Moldova:

There is a voluntary unpaid donation system (opt-out) in place in the Republic of Moldova.

The Republic of Moldova has transposed the Directive 2004/23, which states that:

-Member States shall endeavor to ensure voluntary and unpaid donations of tissues and cells.

-Donors may receive compensation, which is strictly limited to making good the expenses and inconveniences related to the donation. In that case, Member States define the conditions under which compensation may be granted.

-Member States shall take all necessary measures to ensure that any promotion and publicity activities in support of the donation of human tissues and cells comply with guidelines or legislative provisions laid down by the Member States. Such guidelines or legislative provisions shall include appropriate restrictions or prohibitions on advertising the need for, or availability of, human tissues and cells with a view to offering or seeking financial gain or comparable advantage.

-Member States shall endeavor to ensure that the procurement of tissues and cells as such is carried out on a non-profit basis.

In the Law 42-XVI from 06/03/2008 on the transplant of human organs, tissues and cells, article 27 (Prohibition to profit) states that:

(1)It is prohibited to profit financially from donating human organs, tissues or cells.

(2)The donors may receive a compensation, which should be limiting strictly to the coverage of expenses and inconveniences, in particular:

a)Compensation to living donors for the loss of revenues (wages, gains) and for other justified expenses, caused by donation or by other medical actions (examinations); and

b)Payment of justified expenses for lawful medical services or for other technical services rendered in relation to the donation.

(3)Donation and transplant of organs, tissues and cells of human origin may not be the subject of a pecuniary transaction.

(4)It is prohibited to promote the need for transplants of organs tissues and/or cells, for the purpose of offering or obtaining financial profit or similar advantage.

And Article 28 (Prohibition against trafficking in human organs, tissues and cells) states that:

(1)Trafficking in human organs, tissues and cells is prohibited, as is obtaining financial profit or advantage from trafficking in human bodies and their parts.

(2)Trafficking in human organs, tissues and cells qualify as a criminal offence and is punishable by the effective criminal legislation.

TheMission report on“Transposition and implementation of EU Acquis on Tissues and Cells Transplantation and on Organ Donation and Transplantation” drafted in December 2011) by the UNDP considered that these provisions are in compliance with the EU legislation.

-State-of-play of the transplant in the Republic of Moldova:

There are 400 End Stage Renal Disease (ESRD) patients dialyzed in 7 dialysis centers and recorded in the Dialysis Patients Registry. Out of them, an estimated 250 will be included on the transplant waiting list (MoH order Nr. 493 din 16.06.2011) - part of SIA TRANSPLANT. However, taking into account the current population of Moldova (around 3.5 million inhabitants) and the dialysis incidence and prevalence from EU and neighboring countries, an expected 800 patients will be dialyzed in 2016.

In December 2011, the renal transplant activity was (re)-initiated with anunsuccessful intervention from a living donor.

The Independent Commission for approval of organ / tissues / cells procurement from live donors(MoH order Nr.885 din 18.11.2011)approved the first two pairs live donors - recipients.

No liver, heart transplants were performed until now. There are an estimated number of 300 patients with liver failure and 200 patients with cardiac failure.

No bone marrow transplantation has been performed. There are an estimated number of 40 to 50 patients requiring bone marrow transplantationper year.

Regarding estimations for tissue transplantation, 100 cases for cardiac valves and 150 cases for cornea are considered by specialists.

There is no tissue banking available yet. A tissue banking should be available by the end of 2012.

There are 4 ART establishments (1 public and 3 private).

There are no currently established tariffs / costs for the different components of organ / tissues / cells procurement and modalities of reimbursement, but different models are under scrutiny and analysis by the TA and MoH.

The public and medical awareness towards organ, tissues and cells donation is very low in Moldova.

There is in general a rather hostile approach of the press and a negative image of past transplant activities in the country.

The Orthodox Church has a positive approach, supporting in general the cure of severe diseases (renal failure, liver failure, heart failure, etc.) that might be solved through transplantation.

-The National Program for Transplant 2012-2016:

A National Program for Transplant activities covering the period 2012-2016 is in process to be approved by the Government. The MoH and the National Health Insurance Company (NHIC) approved its content and budget in May 2012.

The following objectives and milestones are considered in this official document of the MoH:

  1. Full access of the entire target-population to organ / tissues / cells transplantation;
  2. Full implementation and management of the Transplant Registry;
  3. Access to free post-transplant treatment;
  4. Development of highly qualified specialized centers for post-transplant treatment;
  5. Educational and media promotion programmes for the general public.

Key expected results mentioned in the National Transplant Programme 2012-2016:

a)Organs:

Objectives for 2012:

-10 renal transplantations;

-2 liver transplantations.

Objectives for 2013:

-Two cardiac transplantations.

Objectives per year between 2013 and 2016:

- Increase in the rate per year with: 10 renal - 3 liver - 2 cardiac transplantations.

Objectives for 2016:

-50 renal transplantations;

-14 liver transplantations;

-8 cardiac transplantations;

-100 immunologically tested subjects;

-250 cases of brain death diagnosis.

b)Tissues and cells:

-20 cornea per year;

-20 (350)bone tissue per year;

-3 valves per year;

-up to 10 medullar transplants per year in 2016 gradually increasing.

-The MoH:

The MoH is the central public authority that develops the healthcare policy and strategy in order to ensure the population health and prevent diseases.

The MoH policy includes the following areas:

-Stewardship and management of the healthcare system;

-Funding of the healthcare system;

-Health promotion, health education, disease prevention and State sanitary-epidemiological supervision;

-Regulation and coordination of integrated healthcare service provision;

-Provision of sufficient adequately trained human resources, of the technical and material resources, and of modern cost-effective medical equipment and technologies.

The MoH lays down the policies in the health sphere and ensures the strategic planning of the health system on different levels.

The MoHcreates an adequate regulation environment and ensures the correspondence between the objectives of the policy, the organization, financing and management in the health system; it ensures the stewardship of the health system, defines the standards, sets the priorities and approaches them under the service package principle; ensures a favourable environment for cooperation between the sectors and for social mobilization; finally, it regulates and monitors the quality of services in the health sphere.

The National Health Policy for 2007-2021 has been approved in 2007 and represents a set of priorities and lines of development in the health sphere, established by political will, for a term of 15 years, in order to strengthen the population’s health and reduce the inequalities between different social groups and regions in the country.