Regulatory Strengthening and Capacity Building
WHO continues to assist Member States in strengthening regulatory capacity to tackle SF medical products and does so through focusing on three areas:
- Prevention
- Detection
- Response
Prevention
The primary objective is to prevent SF medical products from becoming available in supply chains and ultimately reaching patients and consumers. A fully functioning National Medicines Regulatory Authority minimises the risk posed by SF medical products entering the regulated and formal supply chain. The registration of medicines and systematic inspection of facilities engaged in manufacturing and distribution to ensure compliance with national and internationally recognised standards are key.
WHO have issued guidance and assessment tools on Good Governance and transparency, particularly in relation to the procurement of medical products. Poor procurement practice has led to SF medical products reaching patients. Shortages of medical products are exploited by those who engage in the manufacture, distribution and supply of SF medical products. Anticipating and preventing shortages, along with transparent procurement practices, can assist in the prevention of SF medical products penetrating supply chains and reaching patients.
A legislative framework setting out clearly the requirements for compliance as well as dissuasive sanctions for non-compliance is important. The framework should be underpinned by the criteria which will be applied to the use of those sanctions proportionately and consistently. It is the aim to create an environment where manufacturers and wholesalers should be confident to quickly report honest mistakes in the knowledge that the regulatory approach will be measured, consistent and proportionate.
Awareness amongst stakeholders of the existence of SF medical products is extremely variable. Patients and consumers need to be provided with sufficient information to be able to make an informed choice on how to avoid SF medical products and what to do if they believe they have one. From healthcare professionals and supply chain professionals to police, customs and the judiciary, all need to be made aware of the existence, risks and impact of SF medical products.
Detection
Even the most tightly regulated supply chains will still be vulnerable to SF medical products. When SF products have penetrated the supply chain it is important to have strategies in place to detect them quickly.
Some countries have already implemented track and trace and authentication technologies throughout their supply chains or at the point of dispensing the medicines. Field screening technologies have been implemented in a number of countries, with regulatory and customs personnel trained to use hand held equipment in the assessment of the authenticity and quality of medicines.
In some countries reporting systems and hotlines for patients, healthcare professionals and those engaged in supply chain management have been established and are used as an early warning system for quality defects in medical products.
Ensuring close collaboration and open communication channels amongst national pharmacovigilance reporting centres, national medicines regulatory authorities, national poison centres and national quality control laboratories leads to the early detection of SF medical products.
Furthermore, systematically targeted post market surveillance of medical products known to represent a high risk as well as regular surveying of essential and high demand products lead to early detection and early interventions.
Response
When SF medical products are detected in the supply chain, a timely, proportionate and effective regulatory response is required.
Common steps to follow include the quarantine or seizure of the product, sampling and laboratory testing to confirm the quality, and the possible rapid alert and recall from the market.
Policies, strategies, processes and procedures need to be in place to assist in managing the incident, ensuring accurate, timely and balanced risk communication, with the focus on minimising the risk to patients and consumers, and securing the supply chains. Information should be shared when the product may be available in more than one country and when collaboration with the relevant stakeholders can improve the response.
Lessons should be learnt from each incident that occurs, and information should be shared with WHO surveillance and monitoring system of SF medical products. Vulnerabilities and weaknesses should be identified, and changes to policy and procedures should be recommended in an effort to prevent repeat incidents.
Training and workshops
We are thankful to all of the Member States and their national medicines regulatory authorities who hosted regional and national training events in the following countries: Argentina; Ethiopia; India; Myanmar; Nigeria; China (People's Republic of); Indonesia; Senegal; Singapore; Switzerland; Thailand; Philippines; Tunisia; Turkey; United Republic of Tanzania; Zimbabwe.