By Daniele Dionisio

The latest World Health Organization / European Union plans to counter the trade in counterfeit and substandard medicines aim to ensure that medicines in the developing world are safe. As such, though both plans appropriately address quality issues, they fall short of adequate coordination and collaboration with each other, and also present substantial flaws.

The poor legislative and regulatory framework monitoring the quality of medicines in the developing countries allows the trade in counterfeit and substandard medicines to boom. This problem must be addressed by ensuring that medicines in the developing world are safe, not by laws and regulations that threaten the availability of affordable generic medications.

Unfortunately, legislation against counterfeit and substandard medicines too often does not address quality issues, but instead is aimed at protecting monopolistic interests. As such, though the latest WHO and EU plans appropriately address quality, they fall short of effective coordination and collaboration with each other, while including substantial flaws.

WHO

On 21 January 2012, the World Health Organization released a Member State Mechanism proposal for international collaboration among member states, from a public health perspective, excluding trade and intellectual property (IP) considerations, regarding substandard/spurious/falsely-labelled/falsified/counterfeit (or SSFFC) medical products.

Member states were urged to voluntarily participate in the Member State Mechanism and provide sufficient financial resources to strengthen the work in the area.

Inherently, WHO will engage itself in:
- ensuring the quality, safety and efficacy of medical products; promoting access to affordable, quality, safe and efficacious medicines; and supporting national drug regulatory authorities, in particular in developing countries and least-developed countries
- information sharing and awareness creation; norms and standards and technical assistance to countries on country situation assessment; national policy development; and capacity building, supporting product development and domestic production
- continuing to focus on and intensify its measures to make medical products more affordable, strengthening national regulatory authorities and health systems, which includes national medicine policies, health risk management systems, sustainable financing, human resource development and reliable procurement and supply systems; and enhancing and supporting work on prequalification and promotion of generics, and efforts in rational selection and use of medical products
- ensuring that combating SSFFC medical products does not result in hindering the availability of legitimate generic medicines
- helping reduce the profit incentive of counterfeiting by ensuring that genuine medicines are affordable and accessible.

While the WHO proposal is shareable, concern arises from:

- possible conflicts of interest bound up with the awareness that WHO’s public financing is decreasing, whereas the private financing is on the rise
- lack of consensus over provisional definitions of SSFFC medical products that focus on the protection of public health
- lack of agreement over WHO’s involvement in the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). The IMPACT, set up in 2006 to improve international cooperation and awareness, lacks a mandate from WHO governing bodies, whereas its agenda on IP issues and the inside role of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) continue to incur criticism concerning conflicts of interest.

Related articles here and here.

European Union

On 1 July 2011, the Directive 2011/62/EU (applicable on 2 January 2013) was released, concerning “medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products.”

The Directive introduces stricter rules to improve the protection of public health with pan-European measures to ensure that medicines are safe and that the trade in medicines is rigorously controlled. It includes:
• an obligatory authenticity feature on the outer packaging of the medicines
• a common, EU-wide logo to identify legal online pharmacies
• tougher rules on the controls and inspections of producers of active pharmaceutical ingredients; and
• strengthened record-keeping requirements for wholesale distributors.

Despite commendable focus on quality issues, the new Directive incurs criticism relevant to the following flaws and coordination gaps:

- common logo for sale at the distance (article 85c) only applicable within EU boundaries
- outer-packaging identifiers only: no measures tabled for chemical composition analysis
- WHO not mentioned as a partner body for field purposes
- “falsified medicines” definition not aligning with WHO terms
- possible conflicts of interest as per the European Medicines Agency (or EMA) fee-for-service relation with industry and distributors it controls
-funding and staff resources hardly enough to cope with the planned, domestic and overseas, controls and inspections.

The inadequate EU coordination with WHO is disappointing at a time when the US administration is committed to keenly protecting the IP rules. As per the US President’s order, criminal procedures and penalties against counterfeiters became harsher in 2011, while a novel Trade Enforcement Unit to fight piracy and counterfeiting was announced in January this year.

These moves add to the Anti-Counterfeiting Trade Agreement (ACTA) and the Trans-Pacific Partnership (TPP) as US-promoted, end-stage international deals reportedly charged with being “closed-doors” initiatives:
• lacking measures to help national regulatory frameworks tackle the quality problems posed by substandard medicines
• allowing customs authorities to seize generic medicines on simple allegations of counterfeiting
• diverting resources from drug quality
• adopting definitions that make no distinction between the willful infringement of trademark on a commercial scale (the only targeted counterfeiting case in the WTO TRIPS Agreement) and the non-fraudulent civil trademark infringement wherein the names or packages of medicines look accidentally similar.
• threatening the trade and import of legitimate generic medicines
• indirectly promoting defective anti-counterfeit legislation pending in some African countries.
• reinforcing and developing (as per a November 2011 agreement by TPP negotiators) existing WTO rights and obligations

Related articles here, here, here, and here.

Priorities for Public Health

In the light of the flaws, threats and gaps discussed here, shared pathways need to be marked out to fully achieve the goal of safe and high-quality medicines worldwide. These include:

- more coordination and collaboration among WHO member states to avoid overlapping, conflicts
- WHO as the most accountable, overarching actor
- WHO to quickly put the Member State Mechanism into action
- the Member State Mechanism as a body entitled to call for an international treaty on medicine quality
- WHO to solve at once the pending questions over “bad medicine” definitions and relations with IMPACT
- donors to strengthen WHO-aligned quality clauses in tender transactions with non-governmental organizations
- purchasers to insist that manufacturers and distributors supply medicines that meet WHO requirements
- governments to authorize export only of products meeting WHO quality, efficacy and safety standards
- EMA to be financed exclusively through EU budget as per application fees channelled to the European Commission
- public financing only
- a Financial Transaction Tax as a resource for relevant funding gaps, as part of global health financing
- anti-counterfeit laws and law enforcement policies not to substitute for effective national regulatory frameworks
- legitimate generics industry to be protected from the inappropriate use of IP law to stifle competition.
- organizations with potential conflicts of interests and IP perspectives to issue statements eschewing the use of IP law to counter generic medicines
- investment in technologies to detect “bad medicines” to be followed up with provisions to increase public awareness and incident reporting, along with regulations on medicine quality that include definitions as per shared WHO terms.

Daniele Dionisio is a member of the European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases. He is reference advisor for “Medicines for the Developing Countries” for the Italian Society for Infectious and Tropical Diseases (SIMIT), and former director of the Infectious Disease Division at the Pistoia City Hospital (Italy). Starting February 2012, Dionisio is head of the research project Geopolitics, Public Health and Access to Medicines (GESPAM). He may be reached at d.dionisio@tiscali.it