Product Policy Archives

UN Report on Generic Drugs Disappoints Business Community

Published on September 22, 2016

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.”

 

Government and Business Discuss Updates on Chemicals Management at APEC

Published on August 18, 2016
APEC Chemical Dialogue
APEC Chemical Dialogue regulators forum

The chemicals trade cuts across many industries, and its products are widely traded across borders. The chemicals industry is a key economic building block in Asia-Pacific Economic Cooperation (APEC) forum economies, and the APEC Chemical Dialogue (CD) serves as a forum for regulatory officials and industry representatives to find solutions to challenges facing the chemical industry in the Asia-Pacific region. It reflects APEC members’ recognition of the importance of engaging with the private sector and building public-private sector dialogue and cooperation for mutual benefit.

Government and industry representatives from 16 economies across the Asia-Pacific region attended the CD meeting in Lima, Peru on August 17 during APEC’s third senior officials meeting (SOM III). Helen Medina, USCIB vice president for product policy and innovation, participated in the dialogue along with USCIB members. During the meeting, officials agreed to revise the CD Strategic Framework document, which includes changes to the dialogue’s shared goals. The framework’s current goals include (1) expand and support cooperation and mutual recognition among chemical regulators in the region to facilitate trade; (2) enhance understanding of the chemical industry’s role as an innovative solutions industry; and (3) encourage chemical product stewardship, safe use, and sustainability.

During the meeting, the group discussed how it will promote the Best Practice Regulation
Checklist which was developed to assist APEC economies when considering changes to
chemicals regulation and when developing new chemicals regulation. The hope is that the
checklist will provide best practices for regulators.

Also noteworthy is the development of a form of self-certification by importers of chemical products, a project which is being conducted alongside the APEC Subcommittee on Customs Procedures.

“The project would develop a certification document to be used by economies that puts the burden of compliance with chemical control legislation on the importer of record and with enforcement of that legislation with the agency who issued the regulations,” Medina said.

The CD also discussed updates on an upcoming paper to examine chemical trade flows, possible contributions to the Strategic Approach to International Chemicals Management policy and the American Chemistry Council’s proposal on sustainable chemistry. During the meeting participants also shared updates on countryspecific initiatives on chemicals management. For detailed information on these items, please contact Helen Medina, hmedina@uscib.org

USCIB Explains How Trade Associations Help Bolster Transnational Governance

Published on June 13, 2016
Helen Medina
Helen Medina

How can trade associations, with their broad industry networks, help develop standards and rules  for their members both in and across borders? On June 10 USCIB’s Vice President for Product Policy and Innovation Helen Medina participated in a conference organized by the Rutgers Law School Center for Corporate Law and Governance, the International Organizations Interest Group (IOIG) of the American Society for International Law, and the Rutgers Institute for Professional Education.

The “Industry Associations and Transnational Governance Conference” brought together practitioners and scholars to discuss the role of trade associations in transnational governance. The aim was to obtain a deeper understanding of how trade associations develop and administer standards and rules for their members and their industries both within and across borders. The discussion also informed the audience how industry associations are involved in formal law-making or soft-rule making bodies of governments and international organizations.

The conference gave Medina a unique opportunity to speak about why industry is interested in international organizations and how the various institutions engage with industry associations and civil society. Medina outlined why it is important for industry to participate in policy discussions and reminded participants that good regulatory outcomes are built on the cooperative effort among government, regulators, the regulated and the broader stakeholder community.

“Policymakers understand this concept of consulting with stakeholders and the importance of having various perspectives in rule making,” Medina said. “Industry associations are often called upon to provide input as experts on a certain topics.”

She spoke about the importance of using a whole-society approach to dealing with global challenges and industry associations and their members play a huge part in bringing solutions to the economy and marketplace.

USCIB Heads to Peru for APEC Policy Dialogues

Published on February 22, 2016

APEC_PERUSupporting six million American jobs and hosting two thirds of the global middle class, the Asia-Pacific region is of great interest to the business community, as global companies are eager to tap the region’s growing markets. The Asia-Pacific Economic Cooperation (APEC) forum – the most influential economic dialogue in the region – continues to be a priority for USCIB members, as it is key to accelerating regional economic integration and promoting balanced, sustainable growth.

To aid private-sector engagement in the dialogue, USCIB works with the U.S. APEC business coalition to give members access to APEC officials and participate in APEC meetings throughout the year, culminating in the APEC CEO Summit, a meeting of CEOs and leaders from the APEC economies.

USCIB is in actively engaged in a number of the APEC working groups related to customs, product policy, and information and communication technologies. Each year, USCIB compiles an APEC priorities and recommendations paper to help direct and coordinate work with our members and APEC officials.

Three of USCIB’s policy team will be attending the upcoming first APEC Senior Officials Meeting (SOM 1) in Lima Peru, which began this past weekend.

Action on trade facilitation

Megan Giblin, USCIB’s director for customs and trade facilitation, will participate in the APEC Alliance for Supply Chain Connectivity (A2C2) and the Subcommittee on Customs Procedures meetings, and will identify linkages to the work underway within the USCIB Customs and Trade Facilitation Committee including, but not limited to, e-commerce, single-window efforts, and other aspects that tie directly to WTO TFA implementation.

Giblin was also confirmed last week as the industry Co-Chair to the APEC Subcommittee on Customs Procedures Virtual Working Group (VWG) along with the government of New Zealand. USCIB both helped create the working group and has facilitated its work, co-chairing the group, since its inception. The VWG is comprised of both customs officials and members of the private sector.

Smarter chemicals regulations

Helen Medina, USCIB’s vice president of product policy and Innovation will attend the APEC Chemical Dialogue (CD) meetings to support USCIB’s work and recommendations on a coordinated approach to implementation of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) and future GHS capacity building workshops. Medina will also support USCIB’s Customs priorities in the area of Chemical Import Procedures.

USCIB will continue to encourage work within the CD on metals risk assessment, specifically follow-up to the workshop on this topic in 2015 as well as the dissemination of pending OECD metals assessment scientific guidance as joint OECD-APEC guidance for APEC Economies.  Lastly, Medina will meet with the Lima Chamber of Commerce, Peru’s most representative organization promoting Peru’s global economic integration, to share USCIB priorities during the Peru host year and collaborate on areas of mutual interest.

Facilitating cross-border data flows

Barbara Wanner, USCIB’s vice president of ICT policy will participate in the SOM 1 meetings of the Electronic Commerce Steering Group (ECSG), with particular focus on the Data Privacy Subgroup. The meetings will focus on expanding APEC economies’ understanding of and participation in the Cross-Border Privacy Rules system (CBPR). The CBPR system requires firms in participating economies to develop their own internal business rules on cross-border data privacy procedures, complying with the system’s minimum requirements. The meetings will also explore a selection of next-generation privacy issues, such as data portability, open data and privacy, and big data.

Wanner  will also participate in a special workshop, “Building a Dependable Framework for Privacy, Innovation and Cross-Border Data Flows in the Asia-Pacific Region,” which will set the stage for subsequent discussions on APEC CBPR and other privacy issues during the informal and formal ECSG and DPS meetings.

If you would like any further information on the above meetings or issues, please feel free to reach out to our team.

Customs: Megan Giblin, mgiblin@uscib.org
Chemicals: Helen Medina, hmedina@uscib.org
ICT and Data Privacy: Barbara Wanner, bwanner@uscib.org
APEC priorities: Rachel Spence, rspence@uscib.org

USCIB Participates in the 4th Int’l Conference on Chemicals Management

Published on October 5, 2015
Medina_SAICM
Helen Medina (USCIB) in Geneva, encourages others to engage in SAICM.

On Friday, October 2, 2015, the fourth session of the International Conference on Chemicals Management (ICCM4) concluded in Geneva, Switzerland.  Over 450 delegates, from governments, international organizations and non-governmental organizations and industry participated in the week-long conference.

The USCIB member delegation included American Cleaning Institute, American Petroleum Institute, Boeing and the Toy Industry Association. Other USCIB members including ACC, CropLife America, Exxon, Pfizer, Johnson & Johnson, and Procter & Gamble participated in the week-long meeting under other international delegations.

ICCM4, the decision-making body for the Strategic Approach to International Chemicals Management (SAICM) made several important decisions meant to promote the 2020 goal “that chemicals are used and produced in ways that minimize adverse effects on human health and the environment.” Additionally, the conference decided on the process for continuing international efforts towards the sound management of chemicals beyond 2020. The process includes an independent evaluation of SAICM and a schedule of meetings, to be agreed by March 2016, to prepare recommendations to be considered at the fifth ICCM in 2020.

“USCIB was indispensable in the negotiations and succeeded in strengthening the role of industries that use chemicals in addition to the chemical industry itself,” said Ernie Rosenberg, president and CEO of the American Cleaning Institute. “The work of USCIB laid the foundation for a leading role as the SAICM process moves forward to the next International Conference on Chemicals Management and the development of a new process beyond 2020.”

USCIB members actively participated in several of the negotiations, one of which was the Chemicals in Products (CiP) program. That program will move into the implementation phase as a voluntary, initiative which would be open to SAICM stakeholders’ input. The program would also be flexible enough to accommodate existing and developing industry schemes. USCIB made interventions to ensure that a separate CiP secretariat would not be created. Instead, the United Nations Environment Programme, in cooperation with the CiP Steering Group, would continue to develop in an open and inclusive manner. Future updates of the guidance documents would be considered as appropriate.

“Beyond the ICCM4 meeting, my, and TIA’s, involvement with SAICM and CiP has been an important component of TIA’s advocacy efforts on behalf of our members,” said Alan Kaufman, senior vice president for technical affairs at the Toy Industry Association. “Helen Medina has done a terrific job of coordinating disparate industry sectors, keeping us all informed, and consolidating and articulating our positions in a coherent manner.”

On the topic of endocrine disrupting chemicals (EDCs), USCIB united with CropLife International, and the International Council of Chemical Associations to highlight that the science on EDCs remains very contentious. Industry noted in the outcome document that the 2012 WHO-UNEP ‘State of the Science Report’ is not an accurate perspective on the current science. Risk assessment was also reaffirmed by many countries as the preferred approach to manage EDCs, and industry successfully supported governments in avoiding a call for the development of lists of EDCs and/or potential EDCs.

With regards to Highly Hazardous Pesticides (HHPs), the crop protection industry worked to introduce sound scientific language on the approach that insists on risk management and risk mitigation. The industry also defeated an NGO-initiated movement to form a Global Alliance to Phase-out HHPs. The Alliance would have been a duplication of efforts on the management of HHPs already being undertaken by the UN Food and Agriculture Organization (FAO) and supported by voluntary industry commitments and actions.

On hazardous substances within the life cycle of electrical and electronic products, the outcome document invites the UN Industrial Development Organization in partnership with the Inter-Organization Programme for the Sound Management of Chemicals (IOMC) to work with others to develop a work plan for hazardous substances used in electrical and electronics products. Original equipment manufacturers should implement various measures including take-back programs, industrial hygiene and environmental monitoring programs, and safer and more sustainable chemistry in manufacturing.

ICCM4 also adopted environmentally persistent pharmaceutical products as a new “emerging policy issue”. The IOMC will develop a work plan, including information generation and sharing, to fill identified knowledge gaps.  For more detailed information on the outcomes of ICCM4, please contact Helen Medina.

USCIB Members Attend 4th International Conference on Chemicals Management

Published on September 29, 2015

ICCM4On the heels of the approved United Nations Sustainable Development Goals and as the UN General Assembly continues, the fourth session of the International Conference on Chemicals Management (ICCM4) began on September 28 in Geneva. During this week-long conference,  ICCM, the governing body of the Strategic Approach to International Chemicals Management (SAICM), brings over 700 stakeholders from sectors that include agriculture, environment, health, industry, labor, economics, science and academia for discussions about how chemicals can be used and produced in ways that minimize adverse effects on human health and the environment by 2020.

“High on the agenda will be an important discussion of how SAICM and its stakeholders can contribute to the Sustainable Development Goals (SDGs) in the context of the SAICM 2020 goal and beyond,” said Helen Medina, USCIB’s vice president for product policy and innovation. “We will also discuss emerging policy issues including chemicals in products, environmentally persistent pharmaceutical pollutants and highly hazardous  pesticides.”

Given the new workstreams that may materialize from ICCM4, several USCIB members are attending ICCM4 this week. USCIB members comply with a variety of national chemicals regulations, and are engaged in initiatives that go well beyond legal minimums, supporting efforts to protect human health and the environment.

“USCIB and its members are actively engaged in the activities related to SAICM, chemicals and green economy discussions at UNEP, chemical deliberations at the OECD and at the Asia-Pacific Economic Cooperation (APEC) Chemical Dialogue,” said Medina. “We are also participating in the ICCM4 dialogue by developing industry positions on SAICM initiatives, coordinating with governments and multinational organizations, and contributing directly to the SAICM process.”

USCIB members attending ICCM4 include the American Chemistry Council, the American Cleaning Institute, Boeing, American Petroleum Institute, Toy Industry Association, Exxon, Procter and Gamble, CropLife America,  Pfizer, Johnson and Johnson and many more.

USCIB, U.S. Take Lead on Alternatives to Forced Localization at APEC

Published on August 28, 2015
L-R: Trudy Witbreuk (OECD); Ken Schagrin (USTR) and Ed Brzytwa (ITIC)

Demonstrating thought leadership on trade facilitation and global value chains (GVCs) in the Asia-Pacific, USCIB participated in a half-day trade policy dialogue during the third Asia Pacific Economic Cooperation (APEC) Senior Officials Meeting (SOM III) in Cebu, the Philippines on August 28. The event titled, “APEC Best Practices to Create Jobs and Increase Competitiveness,” was organized by the APEC Committee on Trade and Investment and convened private sector representatives and officials from the United States and the OECD for a discussion of the impacts of forced localization policies and how best trade practices can serve as sound alternatives to these policies.

Helen Medina, USCIB’s vice president for product policy and innovation attended SOM III and led the session on best practices as alternatives to localization policies in the APEC region during the dialogue. USCIB members participating at the event included Jeffrey Hardee (Caterpillar), Jennifer Mulveny (Intel) and Ed Brzytwa (Information Technology Industry Council).

The event reviewed the APEC Best Practices to Create Jobs and Increase Competitiveness, which were endorsed by the APEC economies in 2013, and highlighted how those practices can be alternatives to local content requirements (LCR). Often LCRs are put in place to deal with one aspect of the economy at the expense of hurting the wider economy. Trudy Witbreuk (OECD) discussed the detrimental impacts that LCRs have had and offered other approaches for policymakers. Namely, the OECD recommends that economies to identify the domestic problem and work on a horizontal approach to resolves the issues. For example, skill shortages are best resolved through targeted training and education policies instead of local labor requirement. The OECD recommended that policies targeted at the regulatory environment, trade and investment barriers, innovation policy and infrastructure development will lead to trade outcomes that are more sustainable over the long run.

“It is not surprising that the private sector panelists echoed the OECD’s recommendation,” Medina said. The private sector participants shared their own stories about why their investments in certain APEC Economies have  flourished.  They highlighted reasons such as good investment environment, highly skilled local labor, and efficient infrastructure. The private sector also unanimously stated that the free flow of data is key to all industries.

The discussion also highlighted possible next steps that APEC can take, such as new guidance on internal coordination of regulatory work.  A summary of the meeting will be circulated to the APEC Committee on Trade and Investment so that further action items can be taken to address LCRs.  It was agreed that APEC economies have economic challenges and that what are needed are sustainable long term solutions.

USCIB and APEC economies have endeavored to make global value chains top-of-mind at APEC dialogues. At last year’s APEC CEO Summit in November, USCIB organized an event on global value chains that gave members an opportunity to discuss obstacles that APEC economies must overcome in order to leverage the benefits of GVCs as well as corresponding policy recommendations to promote economic integration within the region. You may read the outcome document of the November event online.

You may read the outcome document of the November event online.

USCIB has been advocating an APEC work stream on promoting global value chain coordination in the region, including the development of the APEC Strategic Blueprint on GVCs from the 2014 Leaders’ Declaration, which highlights how understanding global value chains is crucial for realizing a more effective policy and regulatory infrastructure for global trade. Following the blueprint, USCIB has been working with the U.S. government to address trade and investment issues that impact GVCs within APEC.

Additionally, USCIB has circulated an ICC Policy Statement on localization barriers to trade.

USCIB Promotes Regulatory Cooperation at Third APEC Senior Officials Meeting

Published on August 21, 2015
L-R: Alexa Burr (ACC), Kate Clemans (Crowell and Moring), Christian Richter (Nickel Institute), Andrew Liu (Chemours), Derek Swick (API), Marianne Heinrich (B&P), Helen Medina (USCIB), Don Wilke (Procter & Gamble), Dusanka Sabic (Accord), Chandra Dantam (Procter & Gamble)
L-R: Alexa Burr (ACC), Kate Clemans (Crowell and Moring), Christian Richter (Nickel Institute), Andrew Liu (Chemours), Derek Swick (API), Marianne Heinrich (B&P), Helen Medina (USCIB), Don Wilke (Procter & Gamble), Dusanka Sabic (Accord), Chandra Dantam (Procter & Gamble)

Central to the modern economy, chemicals and products they are used in are traded widely across borders. Because they add value to so many different consumer goods, chemicals are a staple economic building block for the member countries of the Asia Pacific Economic Cooperation (APEC) forum.

Regulatory cooperation and good regulatory practices was the focus of this year’s third APEC Senior Officials Meeting (SOM III) hosted in the Philippines. Trade officials, regulators and industry representatives from the APEC region met for 3 days to share information, discuss various challenges facing the chemicals industry and agree on action items to address issues of mutual concern.

Helen Medina, USCIB’s vice president for product policy and innovation, attended SOM III from August 25-29, representing USCIB member views at several important meetings, including the APEC regulators forum, the Chemical Dialogue and a workshop on good regulatory practices.

In addition to Medina, other USCIB members attending those meetings included representatives from the American Chemistry Council, Boeing, American Petroleum Institute, British Petroleum, Chemours, Crowell & Moring, Nickel Institute, P&G and the Society of Chemical Manufactures and Affiliates.

Participants at these meetings agreed to work on the following items:

  • A checklist to promote implementation of the Chemical Dialogue Best Practice Principles
  • Outreach to the APEC Economic Committee for further cooperation, including proposing a potential chemical-specific panel during the EC’s Good Regulatory Practice, which will take place in Peru in 2016.
  • A new document outlining the Chemical Industry Priorities for the Negotiation of Regional and Bilateral Free Trade Agreements
  • A new Capacity Building Workshop related to Globally Harmonized System of Classification and Labeling of Chemicals

15th-CHEMICAL-DIALOGUEAt the APEC Chemical Dialogue, USCIB also brought to the table two new ideas to help bolster regulatory cooperation and streamline customs procedures in the APEC region: 1) a self-certification customs form, in which an importer of goods would self-certify that their imports comply, and 2) a regional capacity-building project related to the theme of  “Analogue/Read-across use in Risk Assessment.”

 

USCIB Opposes Stringent Chemicals Regulations in China

Published on July 30, 2015

Test_tubesOn July 30, USCIB submitted comments to China’s Ministry of Environmental Protection expressing concern with draft language in China’s recently revised guidance on new chemical substances. New language suggests that any new chemical substance in an article that could potentially result in exposure to the environment or humans will be subject to full chemical notification obligations.

USCIB noted that this new requirement would be unnecessarily burdensome, imposing exorbitant costs on importers of articles. Importers would face challenges in obtaining information about the presence of chemicals in articles in order to assess potential compliance. This requirement would be imposed even if there is no corresponding benefit to the protection of human health or the environment.

“In others countries, chemical registration or new chemical notification requirements are much more limited with respect to chemicals in articles,” said Helen Medina, USCIB’s vice president for product policy and innovation. “It is not technically or economically feasible to test every article for every chemical that might be contained in each article.”

USCIB members support efforts to protect human health and the environment, and comply with a variety of national regulations including those specific to chemicals.  For this reason, USCIB is actively engaged in the Strategic Approach to International Chemicals Management (SAICM), chemicals and green economy discussions at the United Nations Environment Program (UNEP), and chemicals deliberations at the Organization for Economic Cooperation and Development (OECD) and at the Asia-Pacific Economic Cooperation (APEC) chemical dialogue.