September 6, 2011

Ms. Adriana Velazquez-Berumen,
Acting Director of Essential Health Technologies
Diagnostic Imaging and Medical Devices
World Health Organization
Avenue Appia 20
1211 Geneva 27
Switzerland
Dear Ms. Velazquez:
On behalf of the Global Medical Technology Alliance (GMTA), and as foreseen in
our June 28, 2011 letter, we are providing our ideas for possible joint work withthe WHO. We appreciate the increasingly constructive dialogue to date andhope this identification of areas of common interest and work, within the boundsof WHO rules, will be discussed in our upcoming October 12, 2011 meeting.
The GMTA is a new and growing body. We can offer diverse experience in awide range of technologies, knowledge and experience with different regulatory
and reimbursement systems, and expertise in training and product development
and delivery. However, our resources are limited.
We propose initial work in selected areas. We believe the proposed work items
reflect several areas of shared interests. The Essential Health Technologies(EHT) group may find that some of the topics would also help focus on specificissues for consideration at the planned Second Global Forum on MedicalDevices. As these initial coordination efforts succeed and the GMTA grows, wehope to be able to expand our joint efforts
The GMTA looks forward to working collaboratively and constructively with WHOand other stakeholders, as appropriate, to contribute to saving lives, reducing
disabilities, promoting quality of life, and creating sustainable health caresystems. We welcome Director General Chan’s stated interest in finding
synergies with the private sector and other stakeholders to work with WHO toachieve its goals.
The medical technology industry has a successful history of working to develop
sustainable solutions to improve healthcare infrastructures around the world –and these efforts are increasing. We hope you will view the GMTA as a resourceas the WHO develops its many projects related to medical technology.
Our facilitator in Geneva, Ms. Tatjana Sachse of Sidley Austin LLP, remains
ready and available to contact us at any time with requests or questions you may
have. Her contact information is: tel. (022) 308 00 80 and email:tsachse@sidley.com.
Sincerely,

Ralph Ives
GMTA Co-ChairJohn Wilkinson
GMTA Co-ChairPROPOSED SHARED INTERESTSFOR THE DEVELOPMENT OF A WORKPLANFOR COOPERATIVE EFFORTS BETWEEN
THE WORLD HEALTH ORGANIZATION
AND THE GLOBAL MEDICAL TECHNOLOGY ALLIANCE
Overall Shared Interests
The Global Medical Technology Alliance (GMTA) shares many common goals
with the World Health Organization (WHO). We note that the WHO’s agenda in2011 identifies six broad priority areas, which include ways to promote thedevelopment and strengthening of health systems. Health technologies are oneof the six building blocks identified by WHO as essential for all health systems(along with financing, health workforce, information, service delivery andleadership/governance). Members of the GMTA support the objectives ofproviding safe, effective and innovative medical technology that saves andenhances lives, benefiting people and society. We believe we can meaningfully
contribute to the WHO’s agenda in this field.
In addition, the WHO Office of Essential Health Technologies listed the “4 As” -availability, accessibility, appropriateness and affordability -- as key componentsof its agenda. The First Global Forum on Medical Devices considered a numberof recommendations to advance this agenda, some of which are already being
acted upon.
Taking into account these important WHO objectives, the GMTA suggests thefollowing set of “shared interests” and activities for an initial work program:•••

Ensuring patient and healthcare professionals’ safety;
Delivering Quality Medical Technologies To Patients; andEncouraging Ethical Business Practices

The shared interests proposed below should be viewed as interrelated factors,
each reinforcing the other. For example, improving ethical business practices
would focus on purchasing medical technology based on the best value andsafest high quality products, instead of improper inducements to government
officials and others. At the same time, medical technology is only one of thebuilding blocks of effective health care delivery systems, and must be considered
in relation to the overall needs and resources of a particular society.
Proposed Shared Interests
1. Ensuring Patient and Healthcare Professionals’ Safety
All stakeholders share an interest in ensuring that patient safety is the highest
priority in the selection and use of diagnostic and therapeutic medical
technologies across all health systems. At the same time, protection ofhealthcare workers from avoidable occupational risks is also essential to healthsystems – especially with many developing countries facing a severe shortage oftrained healthcare personnel. Training of health care workers on medical
technology appropriate for each patient is essential. Adopting sound regulatory
requirements and practices, including pre-market assessment and post-market
vigilance, provides greater assurances of patient safety. Regulatory systems
based on harmonized international guidance and standards improve theattractiveness of a country’s market by reducing compliance costs, which arereflected in prices -- thereby enhancing accessibility with greater patient choice,and affordability with lower prices. In addition, measures to reduce the incidenceof healthcare associated infections (HAIs) – by patients and by healthcare
professionals, who are exposed to infectious diseases -- improve safety andaddress affordability through a substantial reduction of healthcare costs byreducing morbidity and mortality from avoidable infections.
The GMTA suggests the following activities to promote patient safety related tomedical technologies.
A. Training: Member companies of the associations represented by theGMTA already provide considerable training to healthcare workers on theuse of medical devices and diagnostics. The GMTA would welcome astructured discussion with the WHO on:••ways to expand and improve training on medical technology indeveloping countries; anddevelopment of information on the impact of HAIs and best practices
to reduce the spread of this very preventable problem (including ourongoing work in the field of injection safety and infection control
through the WHO SIGN initiative).

B. Regulatory Systems: Sound regulatory requirements and practices
promote patient safety through clear, appropriate, efficient, andinternationally consistent regulations covering those who develop, produceand place medical technologies on the market. At the same time, we urgethat governments should establish regulations in line with their abilities andresources to implement and sustain them. Also, as governments develop

regulations, they should ensure that they are harmonized with internationalguidance. Such an approach helps reduce costs and enhances theaccessibility of appropriate medical technology. Some of the steps that theGMTA could take in cooperation with WHO are:•••••Expand the use and understanding of labelling based oninternationally recognized standard symbols for some medicaldevices;
Develop and encourage alternative methods and formats for theacceptance of labelling (e.g., electronic, streaming, etc);
Promote understanding of a structured approach to implementing
medical technology regulations based on Global Harmonization
Task Force (GHTF) guidance;
Work with WHO and member states to promote broader acceptanceand greater use of internationally harmonized regulatory practices;andDevelop regulatory training programs, possibly in conjunction withon-going efforts in other multilateral fora, such as APEC.

2. Delivering Quality Medical Technologies To Patients
Developing and delivering appropriate, affordable and reliable medical
technologies to patients depend not only on determining patients’ needs but also
on research and development (R&D), a functioning supply chain, and fair andtransparent procurement practices. Likewise, the supply chain – frommanufacturer to the patient – should be better understood as part of any
consideration of prices and distribution, especially in an age where lean systems
are deployed widely as a means to drive down costs. Finally, appropriate
methods of purchasing medical technology are critically important to minimize
costs and to ensure patients receive the best quality care.
The GMTA recommends working with the WHO on the following activities topromote a better understanding of, and improvements in, the delivery of quality
medical technologies to patients.
A. Supply chain: Development and manufacturing of medical technology is
only part of the challenge of patient accessibility. Delivery, technical support,and servicing of the products are also essential. The GMTA offers to present
to the WHO an analysis of the various components of the supply chain. Suchan analysis would contribute to the WHO’s project on “Definition of amethodology to measure price components and affordability on medicaldevices.” We would then welcome a discussion of elements of the supplychain.
B. Purchasing: There is a variety of methods used by the private sector andgovernments in different countries in the purchase of medical technology.

There is also a wide range of medical devices and diagnostics currently on
the market at affordable prices in developing countries or being developed fordifferent income levels. We assume the EHT group would be most interestedin helping Member States develop government capacity for the soundprocurement of medical technology. One method governments use is publictendering, however, this often presents challenges of determining quality,evaluating appropriateness, and avoiding discrimination and corruption. The
GMTA is prepared to present studies and recommendations on:•••

Best practices in tendering systems, including quality criteria;
Appropriate use of health technology assessment in medical
technology procurement decisions; andSteps being taken by industry to develop “market appropriate”
solutions to medical technology needs, which would contribute to WHOwork on “Assessment of the World’s Needs for Health Technologies.”

3. Encouraging Ethical Business Practices
In order to promote health development and equitable access to appropriate andaffordable technologies for patients, it is necessary to eliminate unethical andcorrupt practices in procurement. Efforts to do so should be made in thedevelopment, manufacturing, promotion, procurement, management, or use ofmedical technologies. This objective deserves the WHO's attention in its ownright. In addition, eliminating such practices reduces costs to patients andindustry. Studies by Transparency International (TI) and the Organisation for
Economic Co-operation and Development (OECD) show that unethical andcorrupt practices have the most severe impact on the most vulnerable societies.
Eliminating corrupt practices is integral to the sustainability of health caresystems to ensure the availability and supply of safe and appropriate medical
technology for health care providers and patients. Addressing corruption will
become increasingly important as the geographic origin of medical technology
becomes even more diverse. We would welcome the opportunity to work with theWHO in the following areas.
A. Education: Experience suggests that corrupt business practices exist,
probably more widely in countries with weak governance systems GMTA
associations have on-going programs to educate member companies –including through various committees and conferences – to promoteadherence to our codes’ principles. Adherence to the codes applies not justin the associations’ home countries but on a global basis. We recommendthat the WHO convene experts from appropriate institutions (e.g. OECD) andNGOs (e.g., TI) to provide their views and assessments of this problem. The
GMTA could contribute with our ideas.
B. Code Principles: A condition for membership in the GMTA is to have acode of ethical business practices. In addition, individual members of GMTA

are working with countries on harmonized principles of business conduct. For
example, this work was memorialized within APEC as the “Kuala Lumpur
Principles” earlier this year. We recommend that the GMTA work with theWHO to promote an understanding, and expanded adoption, of code
principles.