Short Term Consultant (STC) for Review of the Pharmaceutical Legislation for the Ministry of Health, Cambodia

1. BACKGROUND

           Universal access to health services is not possible without policies to assure affordable access to essential medicines, vaccines and health technologies. However, the use of ineffective and poor-quality medicines and medical products can result in therapeutic failure, resistance to antimicrobial medicines, exacerbation of disease and sometimes to death. It undermines public confidence in health and pharmaceutical supply systems and health workers. To protect public health, comprehensive laws and regulations and competent and effective national regulatory authorities are needed to ensure that the manufacture, trade, and use of medicines are regulated appropriately and that the public has access to assured quality medicines and accurate information on medicines.

          

 However, over time countries’ public health laws may have become outdated, fragmented and   even incoherent in ways that undermine government efforts to manage health challenges  effectively. Globalization has also resulted in a number of global and regional initiatives (for example, the Agreement on Trade-Related Aspects of International Property Rights (TRIPS) and regional harmonization) that must be considered for renewing and updating national regulations and guidelines. 
 

 The Medicines Policy of the Kingdom of Cambodia first introduced in 1995 and updated in 2010 provides guidance on ensuring access to affordable, safe, effective, and good-quality medical products. A regulatory framework for pharmaceuticals is the Law on the management of Pharmaceuticals first adopted in 1996 and amended in 2007. The Pharmaceutical law regulates pharmaceutical products including medicines, biologicals and biosimilars, medical devices,  health supplements, veterinary medicines, traditional/herbal medicines. However, the law is very brief and regulation is fragmented across several ministerial orders and sub-decrees (list of pharmaceutical laws and regulations is attached).  Moreover, enforcement of legislation remains challenging.

  In Cambodia’s hierarchy of laws, matters of broad legal principle, key functions and powers and institutional arrangements are set in higher-level “LAWS” and ROYL DECREES, with SUB-DECREES, MINISTERIAL ORDERS, DECISIONS, CIRCULARS and LOCAL REGULATION used to clarify meaning and intent and provide for practical implementation.

2.    PURPOSE/SPECIFIC OBJECTIVE OF THE ACTIVITY

        Under the direction of WHO Country Office in Cambodia, the consultant (or institution) will be required to evaluate the Law on Pharmaceutical Management and its related regulations in Cambodia and support the process towards the development of a legal framework including laws and regulations for the pharmaceutical sector. The legal framework is expected to cover among others, regulation of the manufacture, import, export, distribution and supply, sale, retail and use of pharmaceuticals and other medical products, to ensure that these processes and systems are aligned with international standards and good practices. The legal framework is expected to result into the availability of quality assured, safe and effective products as well and that medicines and medical products are regulated appropriately while assuring the balance between regulation of and access to essential medicines.

3.    DESCRIPTION OF ACTIVITIES TO BE CARRIED OUT

Under the direction of the WHO Country Office in Cambodia and in close collaboration with Ministry of Health, the consultant will:

1. Provide the necessary expertise and leadership in the review of the pharmaceutical and other relevant laws and regulations. This will encompass the development of a comprehensive assessment tool as well as the methodology for the conduct of the assessment.
2. Develop a framework for conducting relevant stakeholder consultations throughout the process of reviewing, drafting and/or amending the laws and regulations.
3. Undertake a complete mapping of pharmaceutical legislation and relevant laws and regulations.
4. To lead the review and developing of the comprehensive pharmaceutical legislation (primary and secondary legislation) including related laws and regulations as well as relevant guidelines.
5. Upon extensive consultation with MOH, relevant stakeholders and WHO, identify areas for revision of existing laws as well as new provisions that are needed in the context of the evolving needs of the country and development of the pharmaceutical sector.  In addition, mapping of specific legal provisions for different types of medical products shall be undertaken when needed and as necessary.
6. Facilitate stakeholders’ consultation meeting.
7. Submit a report at the end of the consultancy.

4.    METHODS TO CARRY OUT THE ACTIVITY

Mapping of existing laws and regulations, review of laws and regulations, drafting of new law, amending of regulations, consultations with stakeholders etc.
 

1. Output/s

           The following deliverables of the assignment have been identified and will be tied to the release of funds.

   Output 1: The Consultant is expected to develop a tool and methodology for the assessment of existing pharmaceutical laws.

           Deliverable 1.1: plan of the consultancy

           Deliverable 1.2: tool and methodology for the assessment of legislation

           Output 2:  Assessment of the legislative environment and mapping of the current laws and regulations

           Deliverable 2.1:  report of the assessment

           Deliverable 2.2:  mapping and gap analysis of the existing laws and regulations

   Output 3:  Drafted new law on pharmaceuticals and related regulations

           Deliverable 3.1: proposed scope and extend of the new law (pharmaceuticals, medical products etc)

           Deliverable 3.2: draft law on pharmaceuticals based on agreed scopes

           Deliverable 3.3: suggested amendments to relevant laws

           Deliverable 3.4: suggested amendments to regulations and/or development of new regulations as required

   Output 4: Consultation with all stakeholders for greater ownership of the new laws and regulations

           Deliverable 3.1: list of stakeholders to be consulted

           Deliverable 3.2: report of a consultative meeting to discuss the draft law and amendments 

   Output 5: Final consultancy report

           Deliverable 5.1 final report with all deliverables outlined in Output 1-4.
    

          Note: An inventory list of existing laws and regulations will be provided to interested experts  upon           request

2. QUALIFICATIONS & EXPERIENCE

    

EDUCATION

Essential:  University degree in Pharmacy or Doctor of Medicine

Desirable: Post- graduate degree or training on Public Health Law and Pharmaceutical Regulation 

EXPERIENCE

Essential: At least 10 years of proven professional and working experience in assessment, review and drafting of public health and/or pharmaceutical legislation

Desirable: experience in drafting of pharmaceutical legislation for developing countries and/or ASEAN is highly desirable.

TECHNICAL SKILLS & KNOWLEDGE

• Excellent understanding of legislative processes and legal frameworks
• Excellent knowledge in pharmaceutical legislation
• Effective communication skills
• Excellent presentational skills.  
• Ability to work effectively with national regulatory authority experts and stakeholders

  LANGUAGES

  Essential: Fluent in English (writing, reading and speaking)

COMPETENCIES

• Good understanding of medicine regulatory system

  ADDITIONAL INFORMATION:

Start date: 27 May 2019

Duration of Contract: 7 months - 100 working days (to be discussed)

The selected Consultant will be expected to provide a medical certificate of fitness for work.

APPLICATIONS

Qualified and interested specialists should submit their CV {for individual contractors} or Company Profile {for institutional applications} and Expression of Interest {cover letter} to the Supply Officer through WP RO UNGM at < wproungm@who.int > by 30 April 2019. 

The cover letter should outline how their experience and qualifications make them a suitable candidate for this position and should include their proposed daily consultancy fee and availability.

Please use Tender Notice No. WPRO/2019-04/KHM_HSD/TN89273/mom as subject to all submission.  Only successful candidates will be contacted.