Concerted action against the illicit trade in medical products

Pave the ground for a Collective Impact Initiative against the illicit trade in Substandard/Falsified [SF] drugs, medical devices and chemical precursors. Build consensual knowledge and trust among corporate, government and other stakeholders, motivate them through common goals and metrics, and initiate joint action.

Dr. Nikos Passas, PI, 

Professor, Northeastern University

The global trade in substandard/falsified (SF) drugs, products diverted from intended supply chains, and methamphetamine precursor chemicals undermines public health (hundreds of thousands die;  millions suffer ill-health or go untreated annually), leads to long-term drug resistance, causes  at least $75 billion to governments and companies annually, damages brands, distorts competition, disrupts economies, threatens rule of law and security. The gray market for medical products wastes funds targeting vulnerable populations and contributes to health inequity around the world. In China and India, formal and informal manufacturers contribute to extensive economic activity, mixing legal and illicit operations that are only partially regulated and inadequately controlled. Highlighting illicit trade and diversion in gray markets, where actors and methods overlap, would underscore the crisis, enhance controls, provide transparency and accountability.

This challenge is ineffectively addressed due to imperfect knowledge, inadequate laws, diverse interests and priorities, mistrust (PRC and India are singled out for inadequate supervision and control of manufacture and export of SF drugs and precursors; some governments, law enforcement and parts of the public often think of companies as historically part of the problem; competition and secrecy impede smooth collaboration between companies) and lack of coordination or uniform technologies.

Source: PEW Report. (2011)

The main target audience is global society and vulnerable populations who are most victimized by illicit medical trade, esp. in low- and middle-income countries. Their health, financial resources and trust in institutions are undermined by shoddy, overpriced and toxic products, diversion of medicine and PPE, and loss of (international) aid.

We are all victimized by corruption and criminal activities, biased information, shortages of needed products, international tensions and regional conflicts. Too much secrecy, competition, reliance on market forces and pressures get in the way of coming together and recognizing in practice the common interests that may be served through concerted action.

Reliance of legal obligations, moral principles, social responsibility codes and business ethics are essential but insufficient. The need is to meet social goals and build trust, while participants also derive tangible benefits

Companies: brand and income protection, risk management;

Control agencies:  arrests, asset seizure and conviction rates;

Regulators: compliance, prevention, safety and efficacy;

Governments: revenue, public health, economic, justice and security needs;

Citizens: shelter against harmful products and crime; access to health services;

Health organizations and funders (e.g., WHO, Gates Foundation): reduce diversion of medical products to illicit markets, losses and wastage

International organizations: consensus and will to collaborate

Comprehensive data set on the normative and institutional framework and practice on illicit medical trade

A report on the the nature, causes, social organization and public health impact of the illicit medical product trade with recommendations for immediate action and the establishment of a long-term CII

Creation of the preconditions of a successful CII: Transparency, clarification of benefits to each contributing stakeholder, common goals and progress measurement method that will assist in improving the reliable supply of quality medical products and reducing SF/meth societal harm.

The material public good that would come from this work would be reduction of unnecessary illnesses, suffering and deaths. The associated economic cost of healthcare, lost productivity and drug-linked crime would be mitigated. It would enhance public trust in the integrity of the healthcare system, pharmaceutical industry, government agencies and the government in general will increase and lead to benefits in other, unrelated policy areas. Fairer competition, stronger justice and security, less inequity and fewer geopolitical tensions are additional public good outcomes

Our project will serve vulnerable populations, the global community, businesses, and governments alike. The aim is to produce a win-win scenario where all participants promote their organizational or individual ends and achieve tangible benefits, while solving a major public health with economic, equality, justice and security repercussions:

Companies protect their brand, enjoy fairer competition, save money on risk and security management, enhance their reputation, and do good while doing well;

Control agencies receive actionable data, focus their effort, yield better results, such as arrests, convictions, asset seizures, convictions;

Regulators achieve stronger compliance, prevention, safety and efficacy goals;

Governments raise more revenue, improve public health, strengthen the economy, justice and security;

Trust in governments, companies, science, health professionals is boosted

Citizens are sheltered against harmful products and crime, enjoy better health, become more productive and live longer;

Health organizations and funders (e.g., WHO, Gates Foundation) find that tracking financial and product flows can help detect and prevent diversion of medical products to illicit markets, reducing losses and wastage

International organizations and cooperation are supported by consensus and genuine will to collaborate;

The global community’s goals for sustainable economic growth, health, justice, security, equality are promoted, esp. in low- and middle-income countries

Our project will focus on phase I of a CII. Phases II and III will build on that in years 2-3 and beyond. 

CII Phases (Hanleybrown et al., 2012)

The initiative will build on existing efforts and initiatives: "Collective impact efforts are most effective when they build from what already exists; honoring current efforts and engaging established organizations, rather than creating an entirely new solution from scratch.

...It takes time to create an effective infrastructure that allows stakeholders to work together and that truly can ameliorate a broken system. The first two phases alone can take between six months and two years. The scope of the problem to be addressed, the degree of existing collaboration, and the breadth of community engagement all influence the time required. Conducting a readiness assessment based on the preconditions listed above can help to anticipate the likely time required.

Once the initiative is established, Phase III can last a decade or more.” (Hanleybrown et al., 2012).

Beginning in the USA, Europe, China and India, the global nature of this trade will naturally take us to additional stakeholders inside this core geographical area and ultimately beyond this core area to scale up into other markets.

Through a combination of output (interim targets and procedural steps or developments) and outcome indicators (ultimate goals, such as better health, broader awareness, less illicit trade, etc.) 

Output indicators: creation of database with trusted content; selection and buy-in of stakeholders; division of labor; formation of common agenda; development of agreed progress indicators; establishment of forum/means for constant communications and exchange of views and data; assignment of a group or body as backbone coordinating organization

Outcome indicators: initiation of a CI against SF/precursor trade; reduction of adverse effects of SF/precursors: higher rate of police responsiveness to leads; initial increase criminal cases leading to conviction; establishment of direct communications and collaboration between public authorities from China, India, USA, UK and EU; lower rate of adverse health effects from SF drugs; harmonized approach to the regulation and policing of precursors

Progress of a pilot on tracking financial and product flows to identify diversion of products to illicit markets can include higher detection, seizure rates, new actors and networks revealed, increase in seized criminal funds and assets, more responsive law enforcement (investigation of leads), amendments and harmonization of laws, wider use of the Medicrime and UN Conventions, more medical products reaching vulnerable populations

Plenty of challenges and sources of resistance exist as expected in a highly complex, multinational issue.  We will pave the ground for moving to phase II of a CII by providing reliable data, building trust of stakeholders, opening avenues of communication.

• privacy laws preventing data sharing - NDAs

• lack of cooperation between governments, industry, health professionals, regulatory authorities, police, customs services, judiciary, NGOs 

• precise big picture on methods, actors, extent is missing; siloed data in the hands of different organizations

• vulnerable globalized supply chain

• inadequate legal framework (Medicrime and UNTOC; national laws, inaction by control agencies)

• industry checkered history/trust deficit

• high prices for certain drugs incentivize bad actors

• supply-demand mismatches, criminogenic asymmetries

• fragmented regulation, oversight and control, over-emphasis on criminal law/tougher sanctions on synthetic drug issues, while frequently far more lenient sanctions on those involved in SF trade. - currently we do have a program rich but system-poor situation. 

• lack of harmonized language, metrics, communication, transparency, standard technology

• emphasis on online pharmacies and criminal groups, but less on grey markets, diversion, price gouging, which have more complex legal-illegal actor interfaces

• competition, secrecy and not sharing of information/lack of communication

• face saving concerns that impede government policy reform

Northeastern University - Professor

Beijing Normal University (China) - Distinguished Visiting Professor

Anti-Corruption Academy of India - Chair of Academic Council

This is a desperately needed but ambitious project that requires innovative thinking, leadership and financial resources. It depends on a mentality switch from a single-donor-results approach to a collective effort focused on ultimate outcomes and a more complex way of assessing progress. Underlying the simplicity of the CII method is the complexity of contextual, competitive, legal, cultural and economic factors that make it a formidable challenge. It can only gain traction if decision-making actors are on board and committed. So, support has to be sought from an entity appreciative of the need and a sense of urgency, an influential champion that commands respect that bring in CEO-level leaders together, willing to take a chance and able to serve as an instrument of impactful social change. TTC checks all these boxes. It is directly focused on public health challenges and the support of sustainable solutions, involves numerous knowledgeable partners that can help move the needle who can also a) assist with data collection, b) serve as sounding board, c) select and recruit critical participants in the eventual CII to be engineered and d) for facilitation of awareness raising, broad communication of results and capacity building around the world.

We have been in touch with Dr. Evidence, BD and GSK.

Microsoft is involved in a pharma supply chain security initiative, so working with MSFT also would be highly desirable.

Other potential partners are Google (producer of GDELT) and Facebook for additional open data and feedback purposes.

Swiss Re and Palentir could potentially add substantial value with financial and other data, if these can be shared in a sanitized form to protect privacy and ensure compliance with all applicable laws