Background

The United Nations Development Programme (UNDP) is the UN’s global development network, advocating for change and connecting countries to knowledge, experience and resources to help people build a better life. We are on the ground in 177 countries and territories, working with governments and people on their own solutions to global and national development challenges. As they develop local capacity, they draw on the people of UNDP and our wide range of partners that can bring about results.

 The Bureau for Development Policy (BDP) is UNDP’s policy Bureau and backbone of the global practices.  BDP has a key role to play in helping country offices to accelerate human development through strengthening the practice areas within UNDP’s programmes.  BDP supports the development and design of projects that are responsive, effective and contribute to the national-level policies and results.  Driven by demand, BDP provides tools, analysis and capacities for country offices to make a real difference in UNDP’s practice areas.
 
Protecting and promoting the rights of people affected by HIV and marginalized populations is the cornerstone of effective AIDS, public health and development responses. UNDP supports countries to create an enabling human rights environment, promote gender equality, and address the HIV-related vulnerabilities and needs of women and girls. UNDP also works to respond to HIV among men who have sex with men and transgender populations, and supports legal frameworks including enabling trade and intellectual property legislation for improved access to affordable essential medicines and commodities.

As the lead agency on human rights and law within the Joint UN Programme on HIV/AIDS (UNAIDS), UNDP led a high-level Global Commission on HIV and the Law in June 2010 to interrogate the relationship between legal responses, human rights and HIV. The Commission, launched by UNDP Administrator, focused its work on some of the most challenging legal and human rights issues in the context of HIV, the goal being to develop implementable, evidence-informed and human rights-based recommendations for effective HIV responses that protect and promote the human rights of people living with and most vulnerable to HIV. The Commission completed its work in July 2012, with the release of its final report ‘HIV and the Law: Risks, Rights & Health’ on 9 July 2012. This report includes analysis and recommendations on issues of intellectual property law and treatment access.  Commission follow-up activities, led by UNDP in collaboration with UN and civil society partners, at global, regional and country level are already underway and will continue through 2012/2013. These include normative policy/tools development work and technical and policy/advisory support for legislative reviews, national dialogues and action planning for law reform, judicial and Parliamentary sensitization and access to justice programming. The review of a draft medicines regulation law forms part of that follow up.

 Objective:
 
Increasing access to affordable treatment for HIV and related co-infections in low and middle income countries remains a key aspect of UNDP’s work under the UNAIDS Unified Budget and Accountability Framework (UBRAF). Many pharmaceutical markets in developing countries are poorly regulated, which consequently puts public health at risk and erodes public confidence on health care delivery system and specifically on the quality and safety of medicines.
 
One of the main challenges effective regulation is the absence and/or existence of weak laws that empower countries to effectively regulate medicines. The strengthening and harmonising of regulatory standards and practice among counties, through existing regional structures could be one way to address this challenge in resource-poor countries.
 
Based on an initial draft of a model law for medicines registration and harmonization, UNDP plans recruit 3 international consultants to review the draft, in order to assist regional organisations and/or countries in their endeavor to enact or review country national laws and serve as a reference guide in efforts to harmonize medicines regulation and subsequent harmonization of national laws with regional policies, protocols and treaties. Three separate consultants are being recruited on account of the multidisciplinary nature of a medicines regulation law; where distinctive expertise is necessary to review different sections.

Duties and Responsibilities

Under the overall supervision of the Advisor on Human Rights, Law & Access to Treatment, the Consultants will:

  • Conduct desk review, with a view to critique and provide technical inputs to a preliminary model law. The experts’ independent opinions will seek to identify gaps and ensure comprehensiveness taking into account new trends and global developments in medicines regulation and harmonization.
 Specific Deliverables:  Each consultant has 1 specific deliverable:

Consultant 1 Deliverable – review and critique the following areas of a medicines regulation law:
  • Preliminary and General Provisions;
  • Human Resources and development;
  • Monitoring and evaluation of the agency;
  • Miscellaneous provisions.
 Consultant 2 Deliverable – review and critique the following areas of a medicines regulation law:
  • Control of medicines;
  • Dangerous substances;
  • Regulation of other products.

Consultant 3 Deliverable – review and critique the following areas of a medicines regulation law:

  • Permits and licensing;
  • Quality control – import and export;
  • Monitoring of clinical trials.
 Expected Outputs: At the end of the assignment period, each Consultant will have delivered as follows:
  • In the form of a report, each consultant will produce their expert comments, suggestions and concerns on their specified area of the draft model law on in medicines regulation and harmonization (as prescribed above against deliverables of each consultant);
  • Reporting: The consultant will regularly evaluate progress in meeting the specific deliverables with the Advisor, Human Rights, Law & Access to Treatment;
  • Timeframe: The consultant’s assignment is home based and is expected to last a maximum of 15 days, completed part time over a period starting from 1 July 2013 to 15 August 2013.
 Working arrangements: 
  • All applicants should be able to have access to the internet, and be able to work from home remotely.
 Evaluation:

Method: Cumulative analysis method will be used to evaluate proposals.

 When using this weighted scoring method, the award of the contract will be made to the individual consultant whose offer has been evaluated and determined as:
  • Responsive/compliant/acceptable; and
  • Having received the highest score out of a pre-determined set of weighted technical and financial criteria specific to the solicitation;
  • Technical Criteria weight: 70 points;
  • Financial Criteria weight: 30 points.

Only candidates obtaining a minimum of 49 (70%) points on technical part will be considered for the Financial Evaluation.

Criteria for technical evaluation (70 points maximum):
  • Criteria 1: A clearly demonstrated knowledge of access to essential medicines as evidenced by a strong publications record – 50 points;
  • Criteria 2: Excellent writing and editorial skills are essential – 25 points;
  • Criteria 3: Relevant experience developing the capacity of civil society or government officials on intellectual property and access to treatment would be highly advantageous – 25 points.
 Criteria for financial evaluation (30 points maximum):

The following formula will be used to evaluate financial proposal:
  p = y (μ/z), where:
  • p = points for the financial proposal being evaluated;
  • y = maximum number of points for the financial proposal;
  • μ = price of the lowest priced proposal;
  • z = price of the proposal being evaluated.
Payment:
  • The consultants will be remunerated at a maximum daily rate of $500 per day (for 15 days each, completed part time), made in one payment, paid following completion of both deliverables.

Competencies

Corporate Competencies:

  • Demonstrates integrity by modeling the UN’s values and ethical standards;
  • Promotes the vision, mission, and strategic goals of UNDP;
  • Displays cultural, gender, religion, race, nationality and age sensitivity and adaptability.
 Functional competencies:
  • A clearly demonstrated knowledge of access to treatment and intellectual property as evidenced by a strong publications record;
  • Excellent writing and editorial skills are essential;
  • Relevant experience developing the capacity of civil society or government officials on intellectual property and access to treatment would be highly advantageous.
 Communications and Advocacy
  • A proven track record on legal research.

Required Skills and Experience

Education:
  • An advanced degree (Masters level) in international trade law, intellectual property law, competition law, international affairs, or public health law, and a knowledge of at least one of the other substantive areas.
Experience:
  • A minimum of 15 years relevant work experience in the area of public health, regulation, international law or a related field.
Language:
  • Fluency in English is essential.

FC:04210