Importation and distribution of unregistered medicines in the public sector: similarities, differences and shared challenges among Southern African Development Community (SADC) countries

Abstract BackgroundThe purpose of the study was to assess the requirements for approval of the importation of unregistered medicines for use in the public sector in the Southern African Development Community (SADC) countries.MethodsThe study reviewed the legal provisions and requirements to be fulfilled when importing unregistered medicines for the public sector in SADC countries relative to two comparators drawn from countries with stringent regulatory systems through extant document analysis. The relative implementation index score was calculated and used to measure the level of implementing legal provisions and requirements to be fulfilled. Analysis was performed using the STATA software package. ResultsApproximately 13 out of 16 SADC countries had a relative implementation index below 50%. The aggregated implementation index across all SADC countries was 44%, ranging from 4% to 54%, while the two comparators had a relative implementation index of 81% and 85%, respectively.ConclusionImplementing the minimum requirements for importing unregistered medicines for the public sector was deficient compared to the jurisdictions with stringent regulatory systems, and wide implementation gaps also existed within the SADC region.

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Corruption, the Southern African Development Community Anti-corruption Protocol and the principal–agent–client model

International Journal of Law in Context ◽

10.1017/s174455230999005x ◽

2009 ◽

Vol 5 (2) ◽

pp. 147-177 ◽

Cited By ~ 8

Author(s):

Indira Carr

Keyword(s):

Public Sector ◽

Recipient Country ◽

Southern African Development Community ◽

Principal Agent ◽

Civil Service Reform ◽

African Development ◽

The Public ◽

Technical Input ◽

Donor Agencies ◽

Pac Model

Since the 1990s, a number of anti-corruption conventions have been adopted due to pressure from international financial institutions, donor countries and governments of major industrialised nations. One of these conventions is the Anti-corruption Protocol adopted by the Southern African Development Community. This article examines this Convention against the backdrop of the principal–agent–client (PAC) model which influences much of the current anti-corruption measures ranging from legal and civil service reform through to privatisation of the public sector. In focusing on the efforts to fight and prevent corruption through legal and public sector reform, this paper highlights the limitations of externally imposed solutions largely driven by donors. Using Tanzania, a country that has seen extensive technical input from donor agencies in reforming the law and bureaucratic structures, as an illustration, this article argues that the limited success of such donor-driven anti-corruption strategies is attributable to a number of reasons ranging from reform policies of donors and paternalistic attitudes to political shifts and antipathy towards external demands for reforms that are fuelled by the colonial past. This paper recommends that for a recipient country to take ownership of the anti-corruption strategies it is important to tailor the PAC model to the cultural, social and political context of the recipient country so that the solutions are seen as an indigenous initiative, thus enabling sustainable change in attitudes and behaviour.

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Legal Frame Work for Exploitation of Beach Sand Mineral Resources: Historical Perspective and Action by Government of India for conservation

Indian Association of Sedimentologists ◽

10.51710/jias.v38i1.149 ◽

2021 ◽

Vol 38 (1) ◽

pp. 51-53

Author(s):

Rohit Jaiswal

Keyword(s):

Public Sector ◽

Historical Perspective ◽

Mineral Resources ◽

Beach Sand ◽

Value Addition ◽

The Public ◽

Legal Provisions ◽

Frame Work ◽

The Government ◽

First Time

India is bestowed with several Beach Sand Mineral (BSM) occurrences along its 7200 km long coastline. The exploitation/recovery of BSM resources is governed by various provisions of the Acts and Rules issued by the Government of India. Till 1998, the mining of BSM was reserved (excluding garnet and sillimanite) for the public sector only. Department of Atomic Energy (DAE), intending to maximize the value addition of BSM within the country, brought out a policy resolution, which allowed the private entities in mining and processing of BSM resources except for the mineral monazite. Mining and development of any mineral are governed by the Mines and Minerals (Development & Regulation) (MMDR) Act, 1957 and the rules made thereunder. MMDR Act, 1957 has undergone major amendments in 2015 and by virtue of the provisions under the Act, new rules were framed for the first time in the country, exclusively for grant of mineral concession in respect of atomic minerals. As per the provisions of a new rule, all BSM deposits (above threshold) come under the purview of the Government Company or Corporation owned or controlled by the Government. This paper deals with legal provisions for the exploitation of BSM resources and recent amendment by the Government of India for conserving these minerals of strategic importance, in the national interest.

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Strengthening public sector records management through the Information Regulator in South Africa

Journal of the South African Society of Archivists ◽

10.4314/jsasa.v53i1.7 ◽

2020 ◽

Vol 53 ◽

pp. 90-102

Author(s):

Makutla Mojapelo

Keyword(s):

South Africa ◽

Public Sector ◽

Document Analysis ◽

Records Management ◽

Successful Implementation ◽

Management Service ◽

Access To Information ◽

The Public ◽

Extra Effort ◽

National Archives

The Information Regulator in South Africa is charged with the responsibility to regulate access to information. The implementation of the access to information legislation is heavily dependent on proper records management in the public sector; however, there is consensus among researchers that records are poorly managed in the public sector. The purpose of the study is to describe how records management in the public sector in South Africa can be strengthened through the Information Regulator. This qualitative study utilised document analysis and literature review for data collection. The study was limited to one mandate of the Information Regulator, which is the Promotion of Access to Information Act (PAIA). The PAIA was analysed to contextualise the correlation between the Act and records management in the public sector. The study found that the successful implementation of specific sections of the PAIA is dependent on proper records management. While it is acknowledged that the Information Regulator is making inroads into records management space, the study recommends that extra effort needs to be made to strengthen collaboration with the National Archives and Records Service of South Africa, which is charged with a statutory regulatory role for records management in public bodies. A framework was developed to outline the role that the Information Regulator can play to strengthen records management service in the public sector.

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Institutionalization of technological innovations in the public sector of Bangladesh

Bangladesh Journal of Public Administration (BJPA) ◽

10.36609/bjpa.v29i2.221 ◽

2021 ◽

Vol 29 (2) ◽

Author(s):

S. M. Sifat Rahman ◽

Mohammad Imtiaj Hossain

Keyword(s):

Public Sector ◽

Service Delivery ◽

Public Administration ◽

Document Analysis ◽

Technological Innovations ◽

Expert Interviews ◽

The Public ◽

The World ◽

Effectiveness And Efficiency ◽

Governance Innovation

After departing from the ideologies of traditional public administration, Bangladesh has experienced quite a few innovations in public administration. A practical illustration of that is the establishment of the Governance Innovation Unit under the prime minister’s office and the A2i at the ICT division, the first innovation laboratory of its kind in the world. At the same time truly remarkable are the innovations achieved with the help of technology and information in the public sector, especially for a young country such as Bangladesh. Usage of technology is hoped to reduce the rigidity of service delivery, increase effectiveness and efficiency, and also at the same decrease the travel, cost, and visit for the service recipients. Institutionalization of these innovations is vital for making the innovations replicable throughout the whole sector and also for making them sustainable. This paper aims to examine and understand the state of institutionalization of technological innovations in the public sector of Bangladesh, investigate the strategies that are helping to attain that goal, and understand the challenges to the process of institutionalization. The design of the paper is qualitative as it employs rigorous content and document analysis and also incorporates data from expert interviews. The paper concludes with the remark that; Bangladesh has a long way to go in regard to institutionalize the innovations it has been taken and a particular set of planned strategies must be taken to make the innovations sustain and embed in the organizational culture of the public sector in Bangladesh.

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A rapid assessment of the National Regulatory Systems for medical products in the Southern African Development Community

Journal of Pharmaceutical Policy and Practice ◽

10.1186/s40545-020-00255-x ◽

2020 ◽

Vol 13 (1) ◽

Author(s):

S. Dube-Mwedzi ◽

S. Kniazkov ◽

J. B. Nikiema ◽

O. M. J. Kasilo ◽

A. Fortin ◽

...

Keyword(s):

Sustainable Development ◽

Universal Health Coverage ◽

Southern African Development Community ◽

Health Coverage ◽

Member States ◽

African Development ◽

Medical Products ◽

Regulatory Systems ◽

Product Regulation ◽

Universal Health

Abstract Background Access to quality-assured, safe and efficacious medical products is fundamental for Universal Health Coverage and attaining Sustainable Development Goal 3: Ensure Healthy Lives and Well-being for All. To guarantee this right, there is a need for robust and efficiently performing national regulatory systems for the regulation of medical products. Well-functioning regulatory systems apply globally accepted standards which ensure that the level of control is proportionate to the level of public health risk. Objective of the study The study aimed at analysing the regulatory systems for medical products in the 16 Member States of the Southern African Development Community (SADC). It provides an overview of the national regulatory systems for medical products in the region in 2017 and outlines the institutional frameworks, which enable the implementation of regulatory functions. Methodology A survey was conducted in March-December 2017 in English, French and Portuguese. National Regulatory Authorities for medical products (NMRAs) of the 16 Member States within SADC responded to the questions asked and sent in their answers. The survey was constructed around five themes instrumental for implementation of the Universal Health Coverage actions framework. Three of the themes are discussed in this article. Results The outcome of the survey demonstrates that within SADC, NMRAs vary in terms of organisational set-up and modalities of medical product regulation. The majority are within the Ministries of Health, and a few are either semi-autonomous or autonomous. Legal frameworks for medical products are in place for some of the SADC NMRAs, although they vary in the scope of products subject to regulation. Traditional medicines, biologicals and medical devices are regulated, however not uniformly across the region. Conclusion Despite major progress over the years, the survey demonstrates variable levels of governance and regulatory framework among NMRAs in SADC. The survey supports the need for shifting from the broad strengthening of the regulatory systems which exist and are underpinned by the mandates, to more product-type focused approaches. This shift will ensure that medical products are quality-assured, safe and effective for a performant Health Systems attainment of the Universal Health Coverage and Sustainable Development Goals.

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