Medical Supplies include all medicines and other medical products, in particular those included
- on the national essential medicines list
- on the World Health Organisation's list of essential medicines, proprietary medicines or generics, and therapeutic food to address acute malnutrition.
They shall not include veterinary products.
Procurement of Medical Supplies
Irrespective of the value of the contract to be awarded, the Humanitarian Organisation shall procure medical supplies either:
- through an HPC, or
- by launching a procurement procedure
In the latter case, medical supplies must be purchased following a procurement procedure ensuring genuine competition (where possible), between pre-certified suppliers which can offer pre-qualified supplies (i.e. both supplier and supplies must meet internationally recognized standards). To this end, when procuring itself, the partner should get the support of staff qualified in health care (e.g. pharmacist).
Furthermore, considering the countries of operation, the partner should do a risk analysis of possible import obstacles or quality issues. These possible problems should be described in the risks section of the Single Form.
To know more, see also the FAQs nr. 102
Before launching the procurement procedure, the partners will either have available or prepare a list of pre-certified suppliers that will be invited to submit an offer.
In order to be “pre-certified” a supplier will have had to demonstrate that it meets the following conditions:
- its premises and facilities meet internationally recognised standards;
- it is technically capable of ensuring the quality of active ingredients, and
- its products come from approved suppliers.
Please note that a self-certification made by a supplier is not sufficient proof that the supplier meets the international standards.
To assess the fulfilment of the status of pre-certified suppliers, the partner can rely on:
- its own assessment of the suppliers;
- proof of pre-certification by other donor (e.g. USAID)
- certification issued by an internationally recognised or reputable certification body (e.g. a WHO-approved body); or
- certification issued by a Stringent Regulatory Authority (i.e. a medical regulatory authorities in the EU, Japan or the USA)
Procurement Procedure with pre-certified candidates
The partners will send an invitation to negotiate simultaneously to a number of pre-certified candidates that ensures genuine competition (whenever feasible, the invitation should be sent at least to 3 candidates).
The invitation describing the nature of the supplies to be purchased will include at least the following criteria:
Selection criteria (referred to the capacities of the supplier)
|Respect of WHO principles for the production and handling of medical supplies such as||Good manufacturing practice (GMP) and where relevant:
Good storage practices (GSP)
Good laboratory practice (GLP)
Good Clinical Practice (GCP)
WHO model quality assurance standards (MQAs)
WHO's or the Union's Good distribution Practices (GDP)
|Ongoing monitoring of the production and quality control activities|
|Monitoring of customers complaints and remedial follow-up|
|Any other recognition ensuring compliance with at least one of the following standards or equivalent standards:||United States QS 21 CFR part 820) on quality system regulation,
ISO9001/2008 on quality management system
ISO9002/1994 on quality assurance in production, installation and servicing
In their offers, the candidates will have to demonstrate that they can respect these criteria and the partners should have qualified staff to assess the offers.
The award criteria (referred to the quality of the supplies.)
- Respect of minimum quality standards (WHO principles, GMP, GSP, GDP, GLP)
- Respect of the national drug regulation in the country of destination
- Respect of any intellectual property and patent regulation applicable in the country of operation
Where the suppliers or the products already benefit from a relevant pre-certification or pre-qualification, a copy of the certification/qualification document is sufficient to demonstrate the respect of the corresponding selection and award criteria.
When comparing the offers received, the partners will compare prices taking into account the whole treatment per patient (transportation, storage, etc.) and not only the cost per unit. The partner will consult international medicines price databases, such as:
- International Drug Prices Indicator
- The Global Fund Price and quality reporting tool
- The price Information exchange website
- The global price reporting mechanism provided by the WHO AIDS medicines and diagnostics services
- MSF untangling the Web of antiretroviral Price reductions.
Proof of compliance with special provisions
The partners should keep in their files a thorough description of the various procedures described above: pre-certification and procurement procedure.
The partners should also be able to produce certificates of conformity, proof of quality and relevant documentation concerning the pre-qualification of drugs and the pre-certification of suppliers. All documents linked to quality assurance considerations, e.g. positive assessments by entities such as QUAMED and USAID should also be kept in the procurement file as evidence of quality compliance.
EXCEPTION ON QUALITY ASSURANCE DOCUMENTATION
The Annex III is mandatory in all cases as far as quality of food and medical supplies is concerned, regardless of ECHO contribution and regardless of the value of the procurement contract.
If the partner, for circumstances beyond its control, is unable to demonstrate compliance with internationally accepted product standards, it must follow these procedures
The procurement of veterinary medicines, while not subject to the same quality requirements of the medical supplies, shall nonetheless be procured by the Partner with due respect of the applicable best veterinary practices in the field and, where possible, in consultation with an appropriately qualified animal health expert.
Destruction of Medical Supplies and Veterinary Medicines
When procuring medical supplies or veterinary medicines, the Partner shall ensure that adequate provisions are in place to ensure respect of internationally recognised best practices in the destruction of any contract-related supplies that are recalled or expired.