US Working To Block UN High-Level Panel On Access To Medicines Ideas In Geneva And Capitals

The United States, possibly working with like-minded countries, is working to prevent the further spread among international organisations in Geneva of recommendations put forward by the 2016 United Nations High-Level Panel on Access to Medicines, considering them to be ideological driven and dangerous to economic growth. The comments were made by a US official speaking to a recent US industry event in Washington DC involving many of the US intellectual property attachès, at which two attachés from Geneva described latest developments and strategy for the coming year. A key message from attachès to industry: come to Geneva and engage, starting with this week’s Executive Board meeting at the World Health Organization.

The 11^th annual IP Attaché Roundtable was organised on 13 December in Washington DC by the US Chamber of Commerce Global Innovation Policy Center (GIPC), which announced at the event the change of its name in a brand update from the Global Intellectual Property Center.

“Although we do over 100 events I can’t think of one we look forward to more,” David Hirschmann, president and CEO of the GIPC, said at the outset.

Shira Perlmutter, who heads international affairs at the US Patent and Trademark Office (USPTO), opened the event saying they are “privileged” to host the IP attaché program. USPTO has tried in recent years to do more outreach for the program outside of Washington. They are an “absolutely vital part of our work,” on the ground “out there spreading the message.”

Perlmutter said the IP attachés are on the ground worldwide and spread US policy. “Essentially, they are advocates for US policy positions,” she said. They advocate directly with their host governments, and they do a lot of “indirect” advocacy, like training government officials on intellectual property. They also conduct public awareness programs, taking programs from the USPTO headquarters abroad, often staffed by people from the Alexandria, Virginia headquarters. They build grassroots support in other countries, and they assist US stakeholders, she said, events like this roundtable are important parts of their work, reaching out to businesses to assess the needs and expectations of those involved in the IP system, either owners or users of intellectual property.

There are 13 posts in 10 countries, including: Geneva (2), Mexico, China (2), Russia, India, Brazil, Thailand, Peru, Kuwait and Belgium, and most cover multiple countries. Most of the attachés spoke at the GIPC event.

The first panel included: Kristine Schlegelmilch, IP attaché to the World Intellectual Property Organization in Geneva; Deborah Lashley-Johnson, IP attaché to the WTO in Geneva; and Susan Wilson, IP attaché to the European Union in Brussels. The panel was moderated by John Santamauro, senior director, international government affairs at innovative pharmaceutical company AbbVie, and a former IP attaché in Geneva.

New IP Law Enforcement Network

[Update:] One new thing announced at the GIPC event was a new program deploying five specialised prosecutors to provide training and technical assistance to foreign law enforcement in key regions. The Intellectual Property Law Enforcement Coordinator Network is a joint program of the Justice Department and State Department.

More information on the program is here.

According to the release, the network works to:

Assess the capacity of law enforcement authorities throughout the region to enforce IP rights; mentor and deliver training to investigators and prosecutors, aimed at enhancing foreign justice sector capacity to enforce IP; assist in strengthening or developing institutions dedicated to enforcing IP; monitoring regional trends on IP protection and computer crimes; and providing expert assistance on US IP policies and initiatives in the region.

Drilling Down on the High-Level Panel

The message from the government seems to be to align itself with US industry interests. Lashley-Johnson in her remarks used access to medicine as an example to talk about how things are going in Geneva. The US, she said, has been emphasizing the importance of IP protection for economic growth and development.

The past year has been “very challenging” in many of the international fora that she works on, she said. The US has been very strong in opposing any “support, endorsement, or acknowledgement” of the 2016 UN Secretary-General’s High-Level Panel on Access to Medicines, to make sure there is no mandate with respect to the High-Level Panel recommendations, she said.

They are trying to prevent the High-Level Panel recommendations from “being exported to national policies,” which she said would negatively affect markets in developing countries.

The US has been trying to have fact-based conversations about what’s going on in the market, she said, but, “unfortunately there has been that ideological impact” that paints patents as a barrier to access.

They have not been able to “drill down” on what the concern is about intellectual property when 95 percent of medicines are off-patent (to which someone in the audience said, “Right!”), she said, adding, “Why are we still having problems with access?” People won’t let these conversations happen because they are “very focused” on the patent issue, Lashley-Johnson said.

She urged industry that their conversations about innovation and access happening “on the ground” be brought into Geneva.

Messaging on IP and economic development has been rewarding at the WTO, she said, There is a group of friends on IP and innovation, working together to organise topics of discussion around the WTO meetings. Having practical case studies helps with discussions in Geneva, she said.

Since 2012 there has been a “huge body of work” cataloguing innovation policies of WTO members, she said. She has been focused on how to showcase that so they have a resource to go to. For instance, it looks at how IP has been used in various sectors. This is something she said she is focused on for the next year. WTO is working to put a lot of things online to make it more user friendly, and she is working with the secretariat and like-minded countries.

For the WHO Executive Board (taking place this week at WHO), she said, “There is again this intractable position that patents are a barrier to access to health. The strategy by those who support the High-Level Panel report in the last year has not been about getting endorsements, but about getting agencies to adopt certain elements of the report. These include licensing, pricing, patentability criteria, certain topics that seem to have been identified. “That seems to be the game plan,” she said.

For this Executive Board meeting, she said, the WHO secretariat has been working on a document with respect to its activities on access to medicines. The document had not been made publicly available as of the GIPC meeting, but she said, “I do encourage you as soon as the document is on the WHO website, take a look at that report.”

There are concerns she urged stakeholders to look at and share views on. On access to medicines, she pointed to the Global Strategy and Plan of Action (GSPA-PHI) on Public Health, Innovation and Intellectual Property from 2008. There is a GSPA panel review implementation process going on and the panel has come up with recommendations that “really go beyond the scope of this strategy,” she said. It is now getting into areas of licensing, drug pricing, transparency, including of negotiating pricing in various countries.

She appealed to industry representatives to provide feedback on these issues in order for WHO to have more of a dialogue on this, so that for instance just because an expert review recommended something it does mean it is automatically adopted. She urged stakeholders to come to the US mission in Geneva, to engage with the attachés and other parts of government.

WHO Executive Board

On the first day of this week’s WHO Board meeting, it is unclear whether this call to go to Geneva was heard. The numbers of nongovernmental organisations and industry advocates appeared to be about the same as usual, filling the balcony overlooking the Executive Board meeting. The participant list [pdf] for the meeting did not show a significant difference in industry representatives among the nearly 30 pages of “non-state actors” (including some 30 names under the activist group Medicus Mundi alone).

The participant list also did not show any representatives from the Office of the US Trade Representative’s office, nor any US IP attaché, consisting mainly of officials from the Department of Health and Human Services, the US health attaché (and the deputy) from Geneva, and a few other offices dealing with health, security and foreign affairs. The US is only in observer status at the rotating 34-member Executive Board this year. This is the end of the first year of the Trump administration in the US. [Update: a US IP attaché was spotted at the WHO Board meeting today, according to a source.]

In addition, it was unclear what impact the current government shutdown in the United States might have on representation in Geneva, if any. The longer no agreement is reached on a budget in Washington, there will be increasing impact, sources have noted.

[Update: separately, it was noted that moderator Santamauro is registered this week at the WHO Executive Board under the International Federation of Pharmaceutical Manufacturers and Associations, IFPMA, and with his location listed as located in Geneva, though he is based in the US.]

WIPO Windup

Schlegelmilch gave an update on activities at the World Intellectual Property Organization, focusing on three committees.

On the Intergovernmental Committee on Genetic Resources, Traditional Knowledge and Folklore (or traditional cultural expressions), the IGC, she noted that the committee mandate had been renewed again, with six weeks of meetings over the next two years. This includes “a full month” of IGC discussions in 2018 alone, she said. The committee has been working for years toward an international instrument for the protection of these resources, she said, adding that she was “happy to report” that the new mandate is very similar to the existing mandate.

A key element of the committee has been addressing concerns over biopiracy (unauthorised use of genetic resources with little or no benefit to the source country), by discussing an international instrument or instruments for protection of such resources. The mandate continues a focus on an evidence-based approach to claims of problems (which she called “very important to the US”), and they will be able to continue to bring discussions of studies, national experiences and so forth. Examples of experiences could come from companies like those present in the room, she said, such as experiences with disclosure of origin in patent applications. Other items in the mandate are to work on things like databases, which the US has supported over the years, she said.

But, she warned, they anticipate there is going to be “a lot of heavy pressure” from treaty demandeurs to continue to focus on a text-based approach as there is interest from some member states to see a legally binding treaty emerge from this process. They expect to hear calls for quick progress toward a diplomatic conference on a legally binding treaty. “This is what we’re up against,” she concluded.

The Standing Committee on Copyright and Related Rights (SCCR) is “probably the most stakeholder friendly” committee, she said. Following the committee’s successful negotiation in recent years of the Beijing (audiovisual) and Marrakesh (access for visually impaired readers) treaties, the committee has been focused mainly on two topics, she said. Those are: broadcasters’ rights, and limitations and exceptions to copyright in the areas of libraries and archives, and educational and research institutions as well as persons with disabilities other than print disabilities.

On broadcasting, she said there still is a lack of understanding, and she anticipated some very technical discussions.

In general, Schlegelmilch said WIPO discussions tend to have a lot of pressure for “hard results” rather than a “free-flowing” discussion on emerging trends, which might be more positive. The US has repeatedly pressed for the ability to share information without the pressure of a normative outcome, she said. SCCR could be a good “testing ground” for that, she said.

She also mentioned discussion on a scoping study in the SCCR on the evolution of national legal frameworks from 2006 to 2016.

The final area she highlighted was geographical indications (GIs). WIPO – and the US – were able to agree to a biennial budget at the WIPO General Assembly in October because an agreement was reached on an issue related to GIs, she said. She referred to the 2015 negotiation of Lisbon System members to update and expand the agreement on GI protection, in which the US was not able to participate on “equal footing”. So the US has been asking that the system pay for itself. As agreed by WIPO members this year, the Lisbon members will have to take a loan to pay for it, she said.

Also on GIs, she said the WIPO Standing Committee on the Law of Trademarks, Industrial Designs and Geographical Indications (SCT) has not been able to talk about GIs for over a decade, particularly due to EU obstruction, first because of WTO discussions and then because of the negotiation among the Lisbon System members (28 countries). Now, however, the SCT in December agreed to a workplan to be able to discuss GIs there. There is a questionnaire being conducted on practices, which can be helpful for stakeholders in navigating rules around the world.

In general, for WIPO, she said, it will hopefully be a “relatively calm” year, as it is not yet a budget year, and the next election for director general is not until 2020.

Asked how the private sector could engage more meaningfully in WIPO, Schlegelmilch said there are cases where they have opportunities to engage in WIPO, for instance on copyright issues. There is value in coming to Geneva and being able to experience the discussions first hand and be a part of that. She echoed Lashley-Johnson in encouraging industry to come to talk to them to help make the visit to Geneva more “worthwhile,” to target their resources.

EU, OECD

Wilson discussed strategy for the European Union and the Organisation for Economic Cooperation and Development (OECD), for which she is also responsible, noting the European Commission has one year left before its 5-year changeover.

“We need to get in there,” she said, such as for the patent incentives review, get in there and change the conversation. They need to ensure Europe does not turn into “access to medicines part two and send it in a completely unproductive direction,” she said.

“We need you to be more active than you ever have before,” she said. “We need you to be active where we are active.”

On the OECD, she said they are working to make sure incoming OECD members meet highest standards of IP protection.

 

Image Credits: GIPC