PharmTech:
What would you identify as the key provisions on the EU FMD or the US FDASIA in addressing supply-chain security? How can
regulators better harmonize efforts globally?
Brian Johnson
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Byers:
In terms of improving supply-chain security, the key provisions of the FMD are as follows. All active substances, or APIs
imported into the EU, will be required to be manufactured in compliance with GMP equivalent to those of the EU by Jan. 2,
2013. Written confirmation of compliance with this requirement, which will be issued by an authority in the exporting country,
will need to accompany all active substances imported into the EU as of July 2, 2013. Exporting countries may apply for an
exemption to these rules, but no country has been granted an exemption to date. In exceptional circumstances, and where necessary
to ensure the availability of medicinal products, if the API manufacturing facility has an EU GMP certificate, then a member
state may waive the requirement for written confirmation for a period not exceeding the validity of the GMP certificate. Member
states that make use of the possibility of such waiver shall communicate this to the European Commission. The first country
has just been granted an exemption from the written confirmation requirements—Switzerland. The process, which is to be used
by each member state's regulatory authority, has not yet been communicated. In terms of regulators working more closely together,
the mutual recognition of inspection reports is encouraged because this will help regulators to inspect more facilities.
Johnson:
Collectively, the recent legislation in the US and EU will help enhance supply-chain security but we need similar legislative
initiatives in other regions of the world to level the playing field. Our supply chains are complex and global, and because
the weakest link is what criminals will exploit, global harmonization is critical. We are heading in the right direction with
initiatives by regulators to collaborate on auditing, information sharing, and risk analysis. Other stakeholders are collaborating
through organizations such as Pharmaceutical Cargo Security Coalition (PCSC), Pharmaceutical Security Institute (PSI), and
Rx–360. It is hard to single out specific provisions of legislation, regulations, or efforts by specific organizations because
they all contribute in different ways and attack different aspects of the problem. The key will be continued collaboration
and avoiding working in silos, which we tend to do sometimes.
PharmTech:
Could you provide an update on Rx–360's initiatives and activities thus far in 2012 and its focus of activity for 2013?
Byers:
Firstly, as a consortium, we are enhancing and facilitating joint and shared audits. Both audit programs are operational
following a period of piloting. Secondly, we are also addressing a broader range of supply-chain security topics. A new supply-chain
security group was established and has developed and shared best practice documents. Thirdly, we are actively engaging regulators
and educating legislators. In terms of communications, we have organized webinars around many Rx–360 initiatives. We have
also produced 326 news flash reports and process for industry wide messaging, 90 summaries of proposed or passed regulation
or legislation with an average time to publish between 6–10 days, 16 newsletters and conducted 4 open meetings.
For 2013, we have targets to increase membership in all categories and to continue to work on our priorities of the audit
programs, supply-chain security and analysis, and swift dissemination of supply-chain security information.
PharmTech:
To date, what are the three biggest achievements accomplished by Rx–360?
Byers:
I would say that our three biggest achievements are: global collaboration between manufacturers and suppliers within the
organization; a positive opinion from the Federal Trade Commission (FTC) that the audit programs, if operated as described
to the FTC, are unlikely to breach US anti-trust laws; and our ability to pull together world experts to work on a problem
within a tight timeframe (e.g., following the tsunami in Japan).
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