WHO calls for proactive strategies to combat falsified, substandard medicines

The report -- the result of the third meeting of Member States on SSFFC medical products from late October in Geneva, Switzerland – makes clear that national and/or regional regulatory authorities need to structure and improve their processes, as well as to establish proactive strategies for the effective prevention of these so-called SSFFC products from entering the market.

The WHO points to two tasks specifically, which it says are “significant for the detection of actions, activities and behaviours that result in SSFFC medical products​,” and they include quality monitoring inspections and laboratory testing in the supply chain; as well as alerts from track and trace systems, when applicable.

And as far as setting up track and trace systems where they don’t exist, the WHO says, “it is important to observe the circumstances triggering alerts in order to conduct targeted inspections. Some aspects to take account of in alert tracking include the detection of duplicated codes, the attempt to divert serialized products that were previously invalidated for having been stolen, sent out for destruction, intended for marketing outside the national territory, dispensed to patients or any other similar situation​.”

Work Breakdown​

Countries that will help the WHO in its efforts to combat the rise of SSFFC medical products include Brazil, Argentina, Switzerland, the UK and Northern Ireland.

Brazil will lead the development of recommendations for health authorities engaged in the detection of SSFFC medical products, and establish a strengthening and tool-generating programme to contribute to Member States’ training.

The UK, Switzerland and Northern Ireland, meanwhile, will create a focal point network for the exchange of information and consultation among Member States, and establish an ongoing virtual exchange forum via an online portal.

In addition, Argentina will establish a working group to survey the technologies, methodologies and track and trace models in place and to be developed to analyse their advantages and disadvantages and to survey the available authentication and detection technologies and methodologies and analyse their advantages and disadvantages.

The country-by-country divvying up of activities comes as the WHO reiterates the importance of field procedures/inspections to verify compliance with national regulations, including current good manufacturing and distribution practices.

“It is advisable that monitoring activities be carried out in accordance with established procedures, using a risk-based approach that assesses the weaknesses of the medical products supply chain in its entirety and other pieces of information previously obtained, such as the names of the companies involved or tracing activities resulting in the highest number of suspect SSFFC medical products​,” the WHO says.