KEI Intent to Testify and Testimony Summary/Comments on Negotiating Objectives for a U.S.-European Union Trade Agreement (USEUTA)

DATE: December 10, 2018

Intent to Testify and Testimony Summary/Comments on Negotiating Objectives for a U.S.-European Union Trade Agreement (USEUTA)

Luis Gil Abinader.
Knowledge Ecology International
1621 Connecticut Avenue, Northwest, Suite 500, Washington, DC 20009.
Phone number +1.202.332.2670.

Federal Register Notice: 83 FR 57526

Docket Number: USTR-2018-0035-0001

Knowledge Ecology International (KEI) requests the opportunity to testify at the hearing to be held on Friday December 14, 2018 by the United States Trade Representative’s Trade Policy Staff Committee regarding the negotiations on a trade agreement with the European Union.

Below are KEI’s written comments in regard to this hearing and request for comments.

a. General and product-specific negotiating objectives for the proposed agreement.

KEI proposes negotiating objectives in several areas:

1. Medical technologies
   1. Promote innovation for medical technologies, including but not limited to drugs, vaccines, diagnostic tests, gene and cell therapies.
   2. Create more competition for medical technologies that meet appropriate standards for safety and efficacy.
   3. Increase the supply (and overcome the under-supply) of medical research as a public good.
   4. Progressively delink research and development (R&D) incentives from prices of medical products and services.
   5. Protect personal privacy, and/or make policies to promote medical innovation that are least damaging to personal privacy.
   6. Increase transparency of resource flows for research and development and of prices of medical products and services.
   7. Set targets for joint funding of market entry rewards and other R&D costs for antimicrobial drugs, with delinkage of R&D incentives from product prices, subject only to an exception for the payment of antibiotic prescription user fees to finance robust market entry rewards (MERs) or other research costs.

2. Intellectual property rights
   1. Expand access to orphaned copyrighted works.
   2. Avoid evergreening of patent protection on medicines.
   3. Protect open standards and standards-making bodies from anticompetitive and predatory licensing demands from patent holders.

3. Quality of life
   1. Establish a quality of life chapter.
   2. Set minimum standards for the size of seats and the amount of legroom on commercial airlines, in order to avoid races to the bottom that result in a decrease of quality of life and present risks to the life and productivity of travelers.
   3. Set minimum standards for paid parental leave.
   4. Set minimum standards for paid vacation time for employees.

4. Climate change
   1. Establish a chapter for measures that address the need to mitigate and slow climate change.
      1. Set norms for funding research on technologies to lower carbon emissions and otherwise mitigate and adapt to climate change.

5. Access to knowledge and culture
   1. Enhance the production and transparency of, and access to scientific research.
   2. Require public access for government-funded databases and scientific research reports and papers.
   3. Expand access to orphaned copyrighted works.

6. Control anti-competitive practices
   1. Ensure sufficient interoperability and data portability to allow the public to use different clients to share status updates, photographs and videos on the large socially important services/platforms now managed by Facebook and Twitter.

7. Public goods
   1. Enhance funding of programs to address challenges of refugees, natural disasters, piracy on the high seas, cross-border environmental protection, global security and health and climate-related R&D supplied as a public good.
   2. Create a schedule for the supply of public goods. The schedule should have three categories of commitments: commitments that are (1) mandatory and binding, (2) voluntary but binding if placed on the schedule, and (3) soft commitments that are voluntary and non-binding.

8. Enhance cooperation on addressing tax avoidance in order to ensure fairness and sustainable funding for government programs.

9. Protect against dangerous and hostile cyber risks
   1. Enhance the transparency of software, algorithms and protocols for software, and software-enabled products, including in particular cases where software programs present risks to privacy, theft, fraud and other hostile acts.

b. Relevant barriers to trade in goods and services between the U.S. and the EU that should be addressed in the negotiations.

The US and the EU should implement measures to reduce regulatory barriers to the cross-border trade of drugs, vaccines and other similar commodities.

c. Economic costs and benefits to U.S. producers and consumers of removal or reduction of tariffs and removal or reduction of non-tariff barriers on articles traded with the EU.

d. Treatment of specific goods (described by HTSUS numbers) under the proposed agreement, including comments on:

1. Product-specific import or export interests or barriers.
2. Experience with particular measures that should be addressed in the negotiations.
3. Ways to address export priorities and import sensitivities in the context of the proposed agreement.

e. Customs and trade facilitation issues that should be addressed in the negotiations.

f. Sanitary and phytosanitary measures and technical barriers to trade that should be addressed in the negotiations.

Governments should eliminate regulatory exclusivity for orphan drugs, pediatric testing, test data, etc, in favor in monetary incentives or expanded subsidies for clinical trials.

g. Other measures or practices that undermine fair market opportunities for U.S. businesses, workers, farmers, and ranchers that should be addressed in the negotiations.

In addition to the considerations described above, when negotiating and concluding a new US-EU trade agreement the USTR must take care to protect the public through undertaking certain critical objectives and avoiding other detrimental actions.

DON’Ts

1. DO NOT create a (trade agreement) norm for the years of regulatory exclusivity for drug test data;
2. DO NOT tie regulatory marketing approval of drugs, vaccines or other medical technologies to patent landscape.
3. DO NOT create a trade agreement requirement that gene and cell therapies (including CAR T therapy) be defined as products, rather than procedures;
4. DO NOT create a trade agreement standard for patentable subject matter;
5. DO NOT restrict policy space to eliminate the availability of injunctions in certain intellectual property infringement cases, as currently provided under U.S. law;
6. DO NOT require more aggressive provisions on damage for infringement of patents than the core standard of “damages adequate to compensate for the infringement,” currently present in U.S. law;
7. DO NOT extend copyright terms beyond that currently required by the WTO TRIPS agreement;
8. DO NOT prohibit measures to make software code, protocols and algorithms transparent; and
9. DO NOT create post-fixation rights for broadcasting organizations.

DOs

10. DO create a pathway to enhance the cross-border trade of drugs and vaccines that have adequate regulation as regards safety and efficacy, including but not limited to off-patent medicines that lack an adequate number of competitors or any drug for which prices are excessive;
11. In the absence of delinkage of R&D incentives from prices, DO create norms against the use of parallel imports or reference pricing for drugs or vaccines under patent when importing from or referencing countries with per capita incomes less than 50 percent of a national per capita income, subject to appropriate exceptions to this policy when products are subject to shortages or excessive prices;
12. DO require transparency of the costs of each clinical trial subsidized by a government agency;
13. DO require transparency of drug prices, revenues, and quantities of products sold, by country;
14. DO make patent landscapes for medical technologies transparent.
    1. Limit remedies for infringement when the patents on drugs, vaccines or other medical technologies are not constructively disclosed.
15. DO require exceptions to test exclusivity when duplicative testing violates ethical norms for testing regarding animals or human subjects, including a reference to the World Medical Association (WMA) Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects. In this regard, take note of the EU/CA Comprehensive Economic and Trade Agreement (CETA), Article 20.30, on the Protection of data related to plant protection products as one possible model for both animal and human subjects; and
16. DO require deep transparency and technology transfer for the manufacture of biologic drugs and vaccines and cell and gene therapies, to remedy inadequate competition for such products and services, and to reduce risks to patients when using biosimilar products.
17. DO require every country in the EU to publish and update as needed an English translation of the laws for patents, copyrights and other types of intellectual property.
18. DO require full transparency of all licenses to government funded patented inventions.
19. DO require robust exceptions to copyright to protect free expression, and the use of works in education, commentary.
20. DO require the EU to rescind the DIRECTIVE 96/9/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 March 1996 on the legal protection of databases, which is an anti-competitive barrier to the creation and use of databases.