BioVoice News December 2016-January 2017 Issue 8 Volume 1 | Page 36

expert corner

Table 3: Comparator Table Pharmaceutical Sales 2013 and current ICH, PIC / S Affiliation, GDF / TGF qualification
��������
��������������� �����������������
���� ������������
considered for anti-TB medicines procurement? This appears unlikely and could also be a reason why manufacturers from these countries are not widely seen engaging in the business of anti-TB medicines supply or investing in it.
Overriding institutional and functional concerns also raise general doubt on the approach taken in sourcing TB medicines. There is first the objectionable practice of UN organizations accepting tied aid from donors.
������ �������
��������
������
��
��
��
������������
������
��
��
��
��������
������
��
��
��
����
������
��
��
��
�������
������
��
��
��
���
������
��
��
��
��������
������
��
��
��
������
������
��
��
��
������������
������
��
��
��
������
������
��
��
��
������
������
��
��
��
��������
�����
��
��
��
�������
�����
��
��
��
�������
�����
��
��
��
����������
�����
��
��
��
��������
�����
��
��
��
�������
�����
��
��
��
��������
�����
��
��
��
������
�����
��
��
��
����������
�����
��
��
��
���������
�����
��
��
��
�������
�����
��
��
��
������
�����
��
��
��
�������
�����
��
��
��
�����������
�����
��
��
��
���������� ����������
�����
��
��
��
�������
�����
��
��
��
�������
�����
��
��
��
�������
�����
��
��
��
��������
�����
��
��
��
������������
�����
��
��
��
��������
�����
��
��
��
����������
����
��
��
��
���������
����
��
��
��
���������
����
��
��
��
�������
����
��
��
��
�������
����
��
��
��
�������
����
��
��
��
�������
����
��
��
��
��������
����
��
��
��
��������������� ���������������� ��������
(* excluding Puerto Rico sales, 40420 mn US $)
Second, for the core question of determining the markets from which products can be sourced, it does not seem appropriate for public procurement functions of organisations in the UN System to outsource such central issue – moreover without an established accountability relationship- to an external entity, however well qualified it may be. Determining eligible supply sources, or defining these so as to enable direct identification, remains a core function of public procurement institutions. These could, as mentioned, be well linked to a risk assessment scheme.
In conclusion, TB stakeholders are called on to set about establishing a definition of strict national regulatory authorities and to align their quality assurance policies with such definition. Such undertaking will achieve compliance with WHA 62.15 and be serving the public interest by increasing access to affordable medicines. For TB, this would mean an improvement in global TB-control and contributing to ultimate elimination of TB, both for drugresistant and drug-susceptible forms of TB.
Note: Declaration on absence of conflict of interest: I hereby confirm that I have no conflict of interest with regard to this article, the research for and drafting of which has been supported by own funds.
Refrences are available on request
JOHN F. LOEBER
With a background in law and engineering, Mr John F. Loeber, a national of Ireland and Germany and currently Chief Procurement Officer in the UN Stabilization Mission in Haiti( MINUSTAH), has over 25 years’ experience in the UN( UN Secretariat, UNHCR, WHO, UNICEF), EU, national systems and the private sector. His expertise is in public procurement, legal affairs, risk management and technical cooperation, with a focus on Global Public Health from 2004 to 2014. Additional areas of expertise encompass programme and project management, ERP systems, product innovation, grant management, internal control and training. In 14 years with the UN, Mr Loeber has overseen procurement totalling about 1 bn US $ and handled international contracts amounting to approximately 4 bn US $. His professional activities have been supplemented by voluntary ones, e. g. as Staff Member of the WHO Board of Appeal, WHO and UNHCR Staff Association Polling Officer, Editorial Adviser of the WHO Bulletin, and also as Board Chair of the Copenhagen International School.
36
BioVoiceNews | December 2016- January 2017