Late last month the World Health Organization (WHO) published a draft “policy brief” for comments by February 28, 2020. The draft is aimed at regulators of medicines around the world who might be considering the development of new medicines traceability mandates. That pool of countries shrinks each year as more and more new mandates are announced, but considering the wide variations in the quality of the existing regulations, guidance aimed at those who would create new mandates is welcome. Let’s take a look at the draft.
The draft policy brief was created last fall by the WHO “Member State Mechanism for Substandard and Falsified Medical Products”, a body created in 2012 to address the issue of Substandard/Spurious/ Falsely-labelled/Falsified/ Counterfeit medical products (SSFFC)—more recently referred to as simply “Falsified and Substandard” (SF) medical products (see “Anti-counterfeiting Successes and Failures Around the World” and “Pharma Anti-Counterfeiting and Serialization”). You can download a copy of the draft policy brief, some preliminary feedback received from a group of relevant experts and a comment form from the WHO website here.
The core of the policy brief “…outline[s] the features of existing traceability systems and provide[s] guidance on developing [a] workable traceability regulation”, but the key points listed are:
“MS are encouraged to
- Establish a suitable governance for their traceability system based on the analysis of their national environment (e.g. regulatory environment, supply chain management), after evaluating how the different options for this governance will impact interoperability, cost, security and regulatory control;
- Integrate in their plan for a traceability system a costing of the system and a sustainability mechanism to prevent costs from negatively impacting patients, government, supply chain stakeholders, and ultimately access to medicines; and
- Use global standards for product identification, production identification, automatic identification and data capture (AIDC) and data exchange to reduce creation and operating system costs and maximize interoperability.”
The emphasis of the key words is mine. Remember, this document is aimed at regulators, not members of the supply chain. These key points are partly addressed in the better regulations around the world, but unfortunately, many regulations miss them entirely. I have written a fair amount on the first and the last key point (see “DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure”, “The Partnership for DSCSA Governance Is Up and Running”, “Can GS1 Hold Onto Drug Identification Worldwide?”, “GS1 Publishes Version 16 Of Their General Specifications …And Why You Should Care” and “Product Identification And National Registration Codes”). So, yes, I am pretty excited about this new policy brief and look forward to the final version some day.
The working group that created the draft was composed of regulators from a mix of countries with and without an existing medicinal product traceability regulation, and it included representation by the International Coalition of Medicines Regulatory Authorities (ICMRA) and the European Directorate for the Quality of Medicines (EDQM).
The draft does not identify a preference for a single data standard. Most of the examples included are based on GS1 standards. The document says that was unintentional but not unexpected. The WHO views GS1 as a “branded name” and the WHO does not endorse brands, but, it notes, GS1 standards are the most commonly used for medicines, including by numerous UN agencies. The document includes an appeal for harmonization of standards, as in: “New and existing traceability initiatives should consider harmonization of standards to ensure undisrupted systems continuity and sustainability.”
The draft includes a section that explains nine different “features” of existing traceability regulations and offers “considerations” for each one. Some of the considerations include:
- “…MS should set phased and long-term transition and continuity plans, including risk management, coupled with realistic timeframes”
- “Although limited in information capture, some countries have used batch-based tracing of medicines in a phased approach as a first step toward their ultimate goal of unit-level tracing in an effort to spread the costs over multiple budget cycles”
- “Traceability regulations should integrate measures to help prevent falsification (copying) of the unique serial numbers. These may include randomization (EU), external documentation proving authentication (USA), verification (Turkey) and crypto-codes (Russia). It should be noted that these are not fool-proof methods but can be useful tools for preventive efforts”
Another section contains a list of strategies for “Developing a workable traceability regulation”, with more considerations aimed at regulators. These are a set of recommendations countries can follow to ensure their regulation produces the desired benefits for patients and is accepted by the major stakeholders. The strategies covered include:
- Governance & Funding
- Gap Analysis
- Draft Regulatory Requirements
- Exemptions, exceptions and waivers
- Enforcement plan
Each of these are covered briefly but the idea of regulators giving thought to each of these strategies before creating their regulation is relishing.
The WHO intends to update the policy brief based on feedback collected and publish the final version in late October. I suggest you review the draft now and submit comments before the February 28, 2020 deadline.