UN Report on Generic Drugs Disappoints Business Community

health_care_globe_lo-resA recent report published by the United Nations argues that low-income countries should be allowed to override pharmaceuticals patents so they can access a cheaper supply of generic drugs.

The U.S. Department of State issued a press release expressing disappointment with the report and arguing that intellectual property rights in the pharmaceutical industry are essential to medical innovation, which is fundamental to promoting global health.

“We believe that we can both increase access to medicines and support innovation for the development of new and improved drugs for the world’s most critical health challenges,” the statement said. “Indeed, there can be no access to drugs that have not been developed: support for innovation is essential.”

USCIB echoes these remarks and believes that increasing access to life-saving medicines is a complex matter, and countries have a wide array of policies and actions that may be appropriate in promoting the progressive realization of the right to the enjoyment of the highest attainable standard of physical health.

“Robust intellectual property rights support the development of innovative new treatments and drugs,” said Peter Robinson, USCIB president and CEO. “We’re disappointed that this new report fails to recognize the role intellectual property rights plays, and we remain committed to advancing access to new medicines while also fostering innovation and investment.”

 

Successful Policies to Fight Obesity

Healthy food in heart and cholesterol diet conceptAre there any successful policies and programs to fight overweight and obesity? USCIB responded to the UN Food and Agriculture Organization (FAO) Global Forum request for answers to this important question.

“All facets of society, including the private sector, have an important role to play in helping to reduce the incidence and burden of non-communicable diseases (NCDs),” USCIB said in comments submitted to the FAO on June 30. “This view is supported by World Health Organization (WHO) and OECD strategies recognizing that NCD solutions require a whole-of-society approach, multi-sectoral actions, and collaboration among governments, civil society and the private sector. Given the complex and multi-factorial nature of NCDs, it is essential that all stakeholders work together to develop holistic, sustainable solutions.”

The comments note that the food and beverage industry’s efforts to prevent NCDs are guided by sound, science-based polices that include:

  • Providing a range of nutritious product choices and marketing them in ways that promote healthy lifestyles
  • Improving awareness and understanding of nutrition and energy balance
  • Communicating clearly through labeling, packaging, websites, brochures, and in-store communications to enable consumers to make informed choices
  • Undertaking responsible advertising practices, taking into account the special needs of children
  • Emphasizing the importance of achieving a balance throughout life of physical activity and nutrition
  • Partnering with other stakeholders in these endeavors.

The comments also list several examples of voluntary industry efforts that have contributed to the fight against obesity and other NCDs.

Read USCIB’s comments.

Business Calls for Partnerships at World Health Assembly

WHO_hq_full_sizeFollowing several years of negotiations, last week in Geneva the World Health Assembly (WHA) adopted updated rules that will govern how the World Health Organization (WHO) manages relationships with non-governmental actors, such as industry, philanthropic organizations, nongovernmental organizations and academic institutions. The WHO Framework of Engagement with non-State Actors (FENSA) is intended to prevent conflict of interest and avoid the risk of undue influence of non-state actors on the work of the WHO. A copy of the FENSA resolution and text can be found here.  FENSA will likely impact joint initiatives between WHO and other UN bodies, such as FAO, UNEP, etc. and could create precedents impacting business engagement in other UN forums.

Throughout the negotiations, USCIB has stated that in light of the magnitude and breadth of global health challenges, all stakeholders, including from business, should be involved in following and cooperating with WHO’s mission.

“USCIB has consistently emphasized the need for partnerships between business, governments and other stakeholders to fully implement the UN Sustainable Development Goals, including SDG3 on Health, and called on WHO to catalyze those partnerships wherever possible,” said Helen Medina, USCIB’s vice president for product policy and innovation. “It is now our hope that the WHO will implement FENSA inclusively so that member states and the secretariat may fully benefit from the private sector’s practical knowledge expertise, experience, resources and research.”

In particular, Medina noted that implementation should encourage and involve large business networks, such as the International Organization of Employers and the International Chamber of Commerce, in observing and furthering WHO’s work.  Like other United Nations bodies, USCIB hopes WHO will seek the best expertise from the business community, and take advantage of broad business networks to further WHO objectives.

As next steps, the WHO secretariat will create a guidance document to facilitate the FENSA implementation, which is likely to be done in phases. Full implementation is to be achieved in a two-year time frame. The WHO secretariat will also establish a register of non-state actors in time for the next WHA in May 2017. The 2017 WHA is also expected to review progress on implementation of the framework at the three levels of the WHO and then take any decisions necessary to enable the full, coherent and consistent implementation of FENSA.

The FENSA resolution agreed on May 28 indicates that the WHO Executive Board will have a standing agenda item for reporting on FENSA implementation. In 2019, the implementation of the framework and its impact on the work of WHO will be evaluated, and the results of this evaluation will submitted together with any proposals for revision at the WHO Executive Board in January 2020.

USCIB will monitor how the WHO will implement FENSA and its impacts and implications for U.S. companies.  USCIB will seek opportunities to inform the development of the WHO FENSA implementation guidance as appropriate, and monitor any precedents that may arise from FENSA in others UN forums.

USCIB Attends Highest Health Policy Forum

WHO_hq_full_sizeThe World Health Organization’s annual World Health Assembly takes place this week in Geneva, convening health ministers from 194 countries to deliberate on major global health policy issues. Helen Medina, USCIB’s vice president for product policy and innovation, attended the World Health Assembly representing the views of U.S. business.

USCIB has been monitoring and providing input into the WHO’s Framework of Engagement with Non-State Actors (FENSA), a policy that will determine how the WHO interacts with non-state actors including businesses. USCIB recently submitted comments at a U.S. Department of Health and Human Services (HHS) Stakeholder Listening Session calling for clarity as the WHO implements its new framework.

USCIB argues that the proposed FENSA is too stringent, as it would limit the WHO’s ability to fully benefit from the private sector’s practical expertise, resources and research.

“Given the magnitude and breadth of global health challenges, we believe that all stakeholders including business should be involved in supporting the WHO’s policies,” said Medina.

USCIB called on U.S. negotiators headed to the World Health Assembly to push for a resolution that reflects the need for positive measures that invite and enable public-private partnerships to advance the WHO’s mission.

While in Geneva, Medina will be supporting USCIB members on the ground at the assembly, as well as attending side-events related to non-communicable diseases and intellectual property rights and innovation.

Public-Private Collaboration Offers Solutions for Better Health

L-R: Riz Khan (CNN), Robin Nuttall (McKinsey & Company), Jon Woods (Coca-Cola), Jorg Spieldenner (Nestle) and Jan Derck Van Karnebeek (Heineken)
L-R: Riz Khan, Robin Nuttall (McKinsey & Company), Jon Woods (The Coca-Cola Company), Jorg Spieldenner (Nestle) and Jan Derck Van Karnebeek (Heineken)

Last week, the Business and Industry Advisory Committee to the OECD (BIAC), convened a high-level forum to identify the central role for business as partners in bringing innovative solutions in health and well-being.  The business community understand the importance of health, and it can bring benefits and opportunities that will make societies healthier and economies more productive. At the forum participants called on the OECD governments to work with business as an important stakeholder to tackle today’s health challenges.  Speakers identified key priorities and potential solutions for governments to improve the productivity of economies and well-being of populations which included the following:

  • using business collaboration to respond faster to changing consumer and societal needs;
  • scaling up partnerships for promoting healthy lifestyles and behaviors; and
  • developing sustainable healthcare systems that leverage private sector-led innovations.

“This first dialogue of its kind brought together senior representatives from government, the OECD, and the private sector, as well as leading experts in health and well-being working together to improve understanding of current global health challenges and identify effective policy recommendations,” said Helen Medina, USCIB’s vice president for product policy and innovation.

The two-day event featured over 20 speakers that included the following USCIB members:

  • Dr. Bernard Prigent, Head of Medical Affairs Europe, Pfizer Inc.;
  • Dr. Jorg Spieldenner, Head of Public Health Nutrition, Nestle Research Center
  • Jon Woods, General Manager, Great Britain and Ireland, The Coca-Cola Company.

During the first day, the audience learned how the food and drink industries are investing in product formulation and medical nutrition to deliver healthier products for consumers. Industry also demonstrated that is it committed to responsible marketing approaches in communicating with consumers to do its part in promoting healthy lifestyle choices.  As employers, speakers discussed the importance of offering wellness programs, which empower populations and increase productivity.

“Because there is no silver bullet to dealing with chronic diseases, working in partnership with governments and community stakeholders is crucial, as are holistic educational programs that encourage physical activity and healthy life styles throughout ones’ life span,” Medina said.

The second day focused on policies that encourage sustainable healthcare systems. The audience was reminded that 21st healthcare systems must be patient-centered to be effective while also integrating digital technologies to make strides in disease prevention and management. Better cooperation with all stakeholders and integration of key technologies, such as big data, telemedicine and electronic health records can greatly improve the measurement and utilization of health outcomes, leading to improved health outcomes for patients while maintaining financial sustainability of healthcare systems through reduced waste and optimal resource allocation.

With regards to non-communicable diseases, today’s largest cause of mortality across OECD countries, panelists said there’s a need for rapid access to new therapies and innovations to reduce the disease burden. Achieving fast access and managed introduction of new technologies in healthcare systems requires new and innovative solutions, including payment and funding schemes, through cooperation between all stakeholders such as regulatory authorities, payers, health technology assessment agencies, healthcare providers and industry.

New technologies are critical to finding solutions for health challengs but equally important is striking a balance between encouraging innovation and access to new medicines. On this item, engaging all stakeholders in the conversation is a must. The innovation ecosystem is changing, and the private sector is providing new products and services to respond to global health challenges, including ageing and other unmet needs. The pharmaceutical R&D model of innovation is also evolving. Health should be included in all policies, and governments need to strengthen collaboration with the private sector to achieve better patient outcomes. New technologies are still needed to overcome future health challenges, and private sector investments focusing on unmet health needs, with the patient in the center, should be encouraged from a broader policy framework.

The BIAC Health and Wellness Forum was moderated by Riz Khan a well-known CNN reporter. For more information, contact Helen Medina.

USCIB Calls for Inclusiveness in Addressing Global Health Challenges

WHO_hq_full_sizeAhead of the World Health Organization’s (WHO) annual World Health Assembly, the world’s highest health policy setting body, USCIB submitted comments at a U.S. Department of Health and Human Services (HHS) Stakeholder Listening Session calling for clarity as the WHO implements its Framework for Engagement with Non-State Actors (FENSA).

Eva Hampl, USCIB’s director for investment, trade and financial services, spoke at an HHS listening session held to solicit knowledge, ideas and feedback from all stakeholders – including private industry – as the U.S. positions itself to negotiate with other countries at the upcoming World Health Assembly. She urged the United States government to ensure that all stakeholders are included in the development and implementation of the FENSA guidance.

“Under current WHO rules, business organizations like ours, and our broad international affiliates, already encounter roadblocks to observing and supporting most WHO work,” Hampl said. “We are concerned this situation could worsen.”

USCIB argues that the proposed FENSA is too stringent, as it would limit the WHO’s ability to fully benefit from the private sector’s practical expertise, resources and research. Given the magnitude and breadth of global health challenges, USCIB believes that all stakeholders should be involved in supporting the WHO’s policies.

“In our view, FENSA extends already discriminatory and restrictive practices on business, is cumbersome, lacks minimum transparency and accountability, and will set negative precedents in other [United Nations] forums,” USCIB said in a statement submitted to HHS. “It is a step backward and in contradiction to what has been the prevailing international trend by governments and inter-governmental bodies toward innovative and enhanced engagement with private sector entities to advance sustainable development.”

USCIB called on U.S. negotiators headed to the World Health Assembly to push for a resolution that reflects the need for positive measures that invite and enable public-private partnerships to advance WHO’s mission.

BIAC to Hold Forum on Innovation in Health and Well-Being

heart_cardio_resized_ssActive and healthy populations are the backbone of our economies. OECD countries are striving to develop more sustainable healthcare systems that harness innovation to achieve better health outcomes, greater productivity, and well-being. To show what the private sector is doing to address these obstacles, the Business and Industry Advisory Committee (BIAC) to the OECD will hold a Forum on Innovation in Health and Well-Being on May 3-4, 2016 in Paris at the OECD Headquarters.

This two day event will feature interactive panel discussions on innovative on-the-ground projects and explore trailblazing solutions from BIAC’s global membership. In 2017, Health Ministers from OECD countries will meet to discuss the next generation of health reforms and provide future orientations for OECD work. Against this backdrop, the event will allow participants to exchange solutions and policy recommendations with high-level representatives from the business community, governments, and leading voices in the field. The discussions will also explore how healthy populations can be a strong pillar for increased economic productivity and societal well-being. Registration details and an agenda will be soon released.

Fighting Efforts in the UN to Degrade Intellectual Property Rights

intellectual_propertyOne of the most contentious issues during the United Nations COP21 climate negotiations was the push by NGOs and some countries to frame intellectual property (IP) rights as a barrier to environmental goals. USCIB and other business groups made a strong case for IP frameworks, arguing that innovation is crucial for developing solutions to the world’s climate challenges, and thanks to their efforts IP was not mentioned in the final climate treaty agreed to in Paris last year.

However, significant challenges to IP are proliferating throughout the UN system, and concerns remain about the Paris Agreement’s implementation and subsequent climate negotiations. To help push back against attacks on IP protection, USCIB and five other business associations sent a letter to U.S. Senator Orrin Hatch urging the U.S. government “to safeguard innovation at multilateral institutions.”

The letter notes that there is positive precedent for such an approach by the United States, as several IP experts from the American delegation at COP21 worked together to ensure that the Paris Agreement’s text didn’t mention IP and removed uncertainty that could have discouraged continued investments by U.S. companies in clean technology.

Challenges to IP have also arisen in the recently announced UN High Level Panel (UNHLP) on Access to Medicines, and at other international regulatory institutions such as the World Health Organization (WHO). In both cases, the business community is worried that innovators’ perspective will not be taken into account in the agencies’ policy deliberations. The letter encourages the U.S. to prevent the UNHLP and WHO from “constraining business involvement to the detriment of innovation.”

“U.S. leadership will be essential to managing diverse initiatives across the UN system…to ensure that they do not undermine innovation,” the letter stated. “All relevant U.S. government agencies must be aligned in such efforts.”

Read the full letter.

Business Prepares for OECD Health Ministerial on Next-Gen Health Reforms

Helen Medina (USCIB)
Helen Medina (USCIB)

In the wake of the financial crisis, global health issues, such as the rising cost of medicines and the need for health reform, have risen to the top of the global agenda as policymakers struggle to insure the best quality healthcare at an affordable price. As the OECD gears up for its Health Ministerial in 2017, USCIB and the Business and Industry Advisory Committee (BIAC) to the OECD are providing industry input ahead of an expected high-level declaration that will guide governments’ future health priorities.

Helen Medina, USCIB’s vice president for product policy and innovation, attended BIAC and OECD Health Committee meetings in Paris this week to prepare formal comments for the OECD Workshop on High-Cost Medicines. She also attended a BIAC strategy session on June 22 to prepare for the 2017 OECD Health Ministerial, the theme of which is “The Next Generation of Health Reforms.” At the meeting attendees discussed their work on obesity and nutrition, to be presented at an upcoming meeting OECD Health Committee secretariat.

“The OECD’s work on healthcare issues often mirrors World Health Organization priorities,” Medina said. “Because there are limited opportunities for business to engage with the WHO, our engagement with the OECD is especially important as it allows industry to provide expertise and information into the policymaking process that otherwise would not be heard.”

Participants at the BIAC Health Committee meeting agreed that with healthcare issues at the forefront of the global agenda, it is important that the OECD’s work reflects a balanced and holistic approach to dealing with healthcare challenges as the organization gears up for the Health Ministerial in January 2017. The BIAC meeting produced alignment on industry messages on the various OECD projects which could impact industry sectors such as pharmaceuticals, alcohol, beverages, and food. In addition, a task force was created to prepare for the 2017 Health Ministerial.

OECD Workshop on High-Cost Medicines

To provide input for the upcoming 2017 Health Ministerial, the OECD Health Committee organized the “Workshop on High-Cost Medicines” on June 24 to encourage dialogue between governments, experts and the industry on access to effective medicines. Attendees talked about the need to maintain the financial sustainability of health systems while also steering innovation in the pharmaceutical industry. Given that OECD governments are increasingly challenged by the expanding costs of healthcare, the workshop explained how the pharmaceutical industry’s business models impact health sector spending. Industry experts discussed how governments can encourage the right innovation in pharmaceutical care to better respond to unmet medical needs.

Business delivered the following key messages to policymakers during the workshop:

  • Innovative medicines improve patients’ lives;
  • Assessing the value of medicines requires a holistic approach;
  • Innovation requires investment in health;
  • Innovation can deliver significant patient and societal value;
  • A “whole health system” approach is needed to maximize efficiencies;
  • Multi-sectoral partnerships can help address access and affordability.

 

USCIB Calls on WHO to Frame Non-Discriminatory and Pro-Partnership Policy on Non-State Actors

U.S. Health and Human Services Secretary Sylvia Burwell addressed the World Health Assembly in Geneva. WHO Director General Margaret Chan is at right.
U.S. Health and Human Services Secretary Sylvia Burwell addressed the World Health Assembly in Geneva. WHO Director General Margaret Chan is at right.

Governments have decided to postpone action on a controversial proposal to broaden anti-business discrimination and limit participation by   non-state actors in the work of the World Health Organization. On the final day of the 68th World Health Assembly, WHO member states opted to continue discussions of the draft Framework for Engagement of Non-State Actors (FENSA) for another year.

“FENSA proved to be one of the most contentious topics on the WHO’s agenda for this nine-day session,” Norine Kennedy, USCIB’s vice president for international engagement, energy and environment, reported after attending the Geneva assembly. “Despite meetings that carried through the weekend and late into last night, many aspects of the issue are still not resolved as the assembly adjourns today.”

U.S. Health and Human Services Secretary Sylvia Burwell was among the ministers and other dignitaries who addressed the World Health Assembly. “This is an important gathering, because as the world witnessed with the Ebola virus this past year, our planet is too small for nations to operate in isolation when it comes to facing major health challenges,” said Secretary Burwell. “Health threats don’t recognize borders, and we must recognize our need for global solutions.”

Earlier this month, in a joint letter to U.S. cabinet officials, USCIB and other U.S. business groups voiced concerns “about proposals on the table that could unjustifiably restrict the WHO’s ability to engage with the private sector in support of its mission.” Kennedy said the impact on business would touch many industries, and create precedents for anti-business bias in other UN forums. USCIB members and staff, including Helen Medina, USCIB’s vice president for product policy and innovation, were on hand during the World Health Assembly to continue dialogue with government representatives on practical ways to inform WHO deliberations with rigorous technical input and implementation from the private sector.

WHO members agreed to establish an intergovernmental working group on FENSA to continue discussions, with the objective of delivering a conclusion at next year’s World Health Assembly. A first meeting of the working group is tentatively scheduled for October.

Kennedy added that business is still concerned about specific provisions in the current draft FENSA text. These include prejudicial language citing the need to exercise “caution” with respect to certain unnamed industry sectors, overly bureaucratic and complex procedures for both non-state actors and WHO secretariat, and limits on public-private partnerships.

“At a time when the UN Post-2015 Development Agenda and Sustainable Development Goals highlight private-sector engagement on global health challenges, we believe it is possible to address potential conflict of interest and other important concerns consistently and transparently, while also strengthening and encouraging private-sector involvement in the WHO’s important work,” said Kennedy.