Ensuring the Safety and Integrity of the World’s Drug, Vaccine, and Medicines Supply FINAL PART
After nearly two years of closed-door meetings, research and negotiations at the Council on Foreign Relations we came up with a six-point policy recommendation for the G8/20 ,Ensuring the Safety and Integrity of the World’s Drug, Vaccine, and Medicines Supply. In yesterday’s blog post I provided an annotated backgrounder explaining the nature of the problem. Today’s blog is a similarly annotated look at our six policy recommendations to the G8/20.
In order to remedy the drug safety and reliability crisis without significantly reducing access to vital medicines, particularly in poor populations, the G8 and G20 nations should:
Consider elements of the European Council MediCrime Convention and other regional agreements as a framework for worldwide coordination of regulation and safety action[i]
The MediCrime Convention was launched in 2011 and ratification procedures are now underway in most European nations. It is imperfect, but offers a basic framework to build upon upon. At its best, the Convention is a compact between European nations, agreeing to mutual transparency in regulation and enforcement activities; identifying jurisdictional boundaries; providing for commitment to sanctions and penalties of violators of public health.
In its Preamble the Convention notes that false medicines, “by their very nature seriously endanger public health.” Moreover, the Convention clearly states that it “does not seek to address issues concerning intellectual property rights.[ii]
Unfortunately, the Convention consistently uses the word “counterfeit” in lieu of terms agreed upon by WHO, and thus implies emphasis on patent protection and pharmaceutical branding.[iii] Ultimately MediCrime’s strength is in European law enforcement.
Other regional agreements can be drawn upon to identify means of sharing information regarding falsification, unsafe and substandard products, and tracing their manufacture to source. Examples include the APEC Regulatory Harmonization Steering Committee and Operation PANGEA, which was an Interpol exercise that brought together many nations to identify and crack down on the production and dissemination of unsafe medicines.[iv]. Identifying cross-national legal frameworks for collaboration between regulatory authorities should be a matter of urgency for G8/G20 leaders. Ultimately such conventions should have financial instruments or fines built into them, generating funds for strengthening of regulatory systems worldwide, particularly in poor countries.
Create Regional Centers of Excellence for Regulation, Laboratory Work, and API Authentication
The WHO estimates that less than 17 percent of its member states have well-developed drug regulation and around 33 percent have little to no capacity to execute those regulations.[v] Some 20 percent of nations have no legal provisions for regulation of the safety and reliability of medicines; combined, 50 percent are clearly incapable of ensuring the health of their public in terms of drugs and vaccines safety.[vi] Some very small nations have strong laws, but their total regulatory budget and staff renders their legal framework meaningless.
Pooling resources and skills on a regional basis can help solve the capacity side of this equation. The Pan American Health Organization (PAHO), for example, includes small Caribbean island nations as well as economically advanced giants, such as Brazil. Under its harmonization scheme PAHO is building laboratory centers that service the entire region for drug and API safety analysis. It is seeking to harmonize regulatory and enforcement law across the region to allow transparency in surveillance and enforcement data, shared investigation power, and cross-border tracking of fraudulent or contaminated drugs. Though still a work in progress, the PAHO model offers a regional approach that could easily be adopted by the APEC/ASEAN states, the African Union nations, and the Arab League. Regionalization can make safety affordable, and concentrate skilled personnel efficiently.
In March 2012, the East African Community (EAC) Medicines Registration Harmonization Program was launched, with strong political support from the UNAIDS Programme, to ensure access to essential, high-quality, safe, and affordable medicines. The nascent effort is funded by the Partnership for Africa’s Development (NEPAD), the World Health Organization (WHO), the Bill & Melinda Gates Foundation, the World Bank, the UK Department for International Development (DfID), and the Clinton Health Access Initiative (CHAI).
Such regionalization will require sufficient harmonization of regulatorypolicies to allow enforcements within nations that are based on other nation-based lab or surveillance work. Nations that currently lack any regulatory framework must be assisted in designing appropriate legislation that simultaneously promotes vigorous drug safety enforcement while also permitting importation and local production of affordable products. The G8/20 leaders should back these efforts and aggressively encourage transparent exchange among its regulators and creation of financial instruments, potentially derived from stiff penalties imposed on violators, which can be used to bolster legal, inspection, and enforcement capacities.
Create a Common International Numbering System for All Drugs and Pharmaceuticals
Currently, a hodgepodge of numbering systems are used by countries around the world, rendering tracking and authentication of products and medicines from one country, to another nearly impossible. Numbering should identify the product, its site and identity of manufacture, and the date of its original production. A universal numbering system could ease and simplify tracking of medicines, just as zip codes have improved global postal delivery.
Many innovators have developed affordable methods for tracking and authenticating packaged medicines, including systems based on cell phone technology. Holograms, electronic pedigrees, and radio frequency identification (RIFD) all offer laudable methods for tracking drugs and vaccines through the production and distribution chain.[vii] But the technology is hampered in a globalized world by failure to normalize numbering standards worldwide.
Encourage an Alliance of Regulators
- Work closely on a regulator-to-regulator basis with counterparts in other countries, sharing in a timely fashion information on substandard, falsified, fraudulent, and contaminated medicines;
- Assist nations within their region in strengthening regulatory capacity, both through legislation of appropriate legal instruments and in training of surveillance, investigation, and laboratory personnel;
- Identify areas of easy convergence of law and practice.
Donor nations should encourage their foreign assistance providers to feature drug safety capacity building
In the absence of new money applied to the pursuit of global drug safety, existing resources may be far better directed. Donor states that currently manufacture or support the distribution of large amounts of pharmaceuticals and vaccines to poorer countries should feature training and support for drug authentication and safety as financed components of such drug delivery. Similarly, appropriate technology for rapid identification of substandard and fraudulent drugs should be provisioned not only by donor governments, but their funded nongovernmental partners.
Major Private Sector Players in Internet Hosting, Search, and Distribution of Drugs and Pharmaceuticals should Endeavor to Ensure the Reliability of Online Retailers
Over the last three years, Interpol has executed criminal sweeps that have identified and removed thousands of websites that sell unsafe or counterfeit medicine.[ix] One website host company, GoDaddy.com, has removed 80,000 such websites in just two years, which is estimate estimated to represent about 2 percent of the total illegal web medicines operations. Relevant companies, such as Google, Microsoft, and GoDaddy, are working to form a consortium that can quickly identify and remove online retailers engaged in dangerous medicines distribution. This should be encouraged.
Moreover, the private sector should be encouraged to expand their efforts to identify illegal providers of excipients and APIs. Regulators should work closely with the private sector to ensure that identification of illegal or dubious on-line retailing does not undermine bona fide provision of low-cost medicines, or diminish access to affordable drugs for all.
It is not appropriate to allow the global free market to decide the fate of patients. Market forces for pharmaceuticals, generics, vaccines, and medicines are under spectacular tension at this time, due both to larger macroeconomic trends and heightened demand. Every government and bulk purchaser seeks to decrease their total costs of vital medicines. The pressure on manufacturers is tremendous: make more of everything, do it at lower cost, and distribute throughout the entire world. At the same time, thousands of new manufacturers are entering the market, creating positive competitive forces. But competition directed at the single price point target can encourage corner-cutting, substandard production, API substitution, and other practices that threaten public health.
Increasingly stock-outs and profound drug shortages have resulted from the price-point pressure. Drug and vaccine supply dwindles, or disappears, when profit incentive drops towards zero. Where demand far exceeds supply, opportunity for criminality arises. Repurposing expired medicines, selling “vaccines” containing no antigen to desperate families in an epidemic, swapping expensive active ingredients for cheap-but-toxic ones, encouraging widespread drug resistance by deliberately diluting antimicrobials in order to stretch supplies or selling phony medicines online – these are the efforts of criminals.
No single drug safety agency today has the capacity to protect its population from substandard or criminally formulated medicines. The crisis is global, growing and massive. Unless international solutions are eagerly embraced, such as we and others have recommended, the very integrity of Medicine and Public Health will be undermined amid a steadily rising toll of illnesses and deaths ascribed to bad medicines. The dramatic achievements in malaria and HIV control and treatment made since 2000 could be reversed by weak, substandard formulations that encourage drug-resistant falciparum parasites and lethal surges in HIV in the bodies of under-medicated people. The world must urgently act to globalize threat reduction in health and medicine.
Given the global scale of this rapidly escalating drug safety and reliability crisis, some analysts insist solutions must await creation of a multi-billion dollar international regulatory authority, and/or a world treaty agreement. The current macroeconomic and political atmosphere in the world does not, however, favor creation of new multilateral agencies or global treaty agreements. One day such grandly scaled interventions may be realistic, but millions of lives will be lost in the meantime unless far more immediate and remediable efforts are executed. The integrity of the global drug and vaccine supply must be decoupled from patent protection, and aggressively tackled through transparent collaborative relations between existing national safety regulators, and rapid capacity building where regulation is weak or nonexistent.
[i] Council of Europe. Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health. 2011.http://www.coe.int/t/DGHL/StandardSetting/MediCrime/Medicrime-version%20bilingue.pdf .
[iii] World Health Organization. Substandard/spurious/falsely-labelled/falsified/counterfeit medical products. 130th Session, Agenda item 6.13, EB130.R13, Geneva: World Health Organization, 2012.http://apps.who.int/gb/ebwha/pdf_files/EB130/B130_R13-en.pdf.
[iv] Taylor P. Pangea IV nets illegal medicines worth around $6.3m. SecuringPharma 2011.
[vi] Finlay B. Counterfeit Drugs and National Security. Washington, DC: Stimson Center, 2011.
[vii] Roach B and Wunder G. Electronic Pedigrees and Counterfeit Pharmaceuticals: The U.S. Experience With RFID. Regional Business Review 2008: 137-159.http://ir.washburnlaw.edu/bitstream/10425/181/1/Electronic%20Pedigrees%20And%20Counterfeit%20Pharmaceuticals%20The%20U.S.%20Experience%20With%20RFID.pdf; Tri-Optic. RFID Frequently Asked Questions. http://www.tri-optic.com/media/pdf/TRI-RFFAQ_Web.pdf; Purdue Pharma RFID Enabled Packaging, United States of America. Packaging-Gateway. 2012, http://www.packaging-gateway.com/projects/purdue/.
[viii] Laursen L. Overwhelmed drug regulators seek cure in cooperation. Nature Medicine 2011;17: 753.http://www.nature.com/nm/journal/v17/n7/full/nm0711-753.html .
[ix] Operations. Interpol 2011. http://www.interpol.int/Crime-areas/Pharmaceutical-crime/Operations/Operation-Pangea .
[L1]From: Pew Health Group