UNCTAD: IPRs In Health, Research, Cosmetics, Meet Access & Benefit Sharing

The interactions between intellectual property and international rules of global access and benefit sharing were explored recently as an expert group meeting was convened by the United Nations Conference on Trade and Development (UNCTAD) to explore several areas where those interactions occur.

The Ad Hoc Expert Group Meeting on the Development Dimensions of Intellectual Property: Biological Diversity and Access and Benefit Sharing (ABS), was convened by UNCTAD on 16-17 April. Several panels shed light on IP and ABS in particular areas, such as natural ingredients used in pharmaceuticals and cosmetics, and pandemic influenza preparedness.

In the context of global public health and access and benefit sharing, Anne Huvos, legal officer at the World Health Organization Department of Public Health, Innovation and Intellectual Property, presented the Pandemic Influenza Preparedness Framework for the sharing of influenza viruses and access to vaccines and other benefits, referred to as the PIP Framework.

She said the framework brought together member states, industry and other “key stakeholders,” such as non-governmental organisations and the WHO, to implement a global approach to pandemic influenza preparedness and response. The framework only applies to the sharing of H5N1 and influenza viruses with human pandemic potential, not to seasonal influenza viruses, she said.

Steven Solomon, principal legal officer at WHO, said that a key challenge is manufacturing capacities. Building the capacity to address needs in the case of pandemic and making sure that the benefits of the influenza surveillance system are widely shared depends on viruses coming into the system. This entails a level of trust in the system from member countries. If countries do not feel this system is working, it might break down, putting at risk this global system for pandemic influenza monitoring, he said.

Using Natural Resources, a Challenge for Pharma

Andrew Jenner, director of innovation, intellectual property and trade for the International Federation of Pharmaceutical Manufacturers’ Associations, described the drug discovery process with an average figure of between US$ 1-1.5 billion cost to get a successful drug. That figure includes all failures that might arise in the process of finding this successful drug, he said.

When it comes to natural products, he said, industry has to face additional risk factors. The first one is the risk of supply. To develop a new drug, the process requires an adequate volume of supply, he said. “In Geneva, often people think that one leaf will be enough to make your blockbuster medicine,” he said, but in fact, “rooms and rooms full of leaves” are necessary “if it is a leaf you are looking at to be able to make that pharmaceutical.” A significant quantity of material is needed, so industry needs to make sure that the supply is reliable by securing such supply with prior informed consent (PIC) and benefit sharing agreements for at least 10 years, he said.

Jenner added that another problem is safety and efficacy approvals, because it is a natural product and the effect on the human body are unknown. Companies could face biopiracy claims, which would be avoided if natural products could be obtained directly from a country under PIC and mutually agreed terms (MAT). However, in many cases, that is not how research on natural products takes place, he said. Sometimes, it takes several intermediaries working with the products in different settings and research facilities over a number of years before it gets to the development stage. The investment comes at the last link of the process and there is legal uncertainty for those people developing natural products into something that is marketable, as they are unable to ensure that all parties have respected their obligations under the UN Convention on Biological Diversity (CBD), he said.

Risk factors have been hindering innovation in that area in recent years, he said, adding that industry is a firm supporter of the CBD and the access and benefit sharing system. Industry “wants to do due diligence because nobody wants a biopiracy claim coming at the end of the process, when some countries can invalidate your patent,” he said. “We want a system that is clear and transparent where everybody understands his rights and obligations.”

Perfume, Cosmetics, Growing Patent Use

Maria Julia Oliva, senior advisor on ABS for the Union for Ethical BioTrade (EUBT), said the EUBT manages an internationally recognised standard: the Ethical BioTrade Standard, under which companies commit to ethical sourcing practices.

Benefit sharing is a critical part of sustainable work with biodiversity, she said, in particular because it empowers producers and their communities, allows long-term partnerships, offers recognition of rights over resources and knowledge, and promotes sustainable development at the local level.

Traditionally, the cosmetic and perfume industries have not been strong users of the patent system, she said, but the trend is changing with a growing number of patents in those fields.

Patents are being used in this sector as companies try to protect their research on the efficacy of ingredients and to protect certain areas or product types for which they are well known.

The concerns from governments and civil society on the use of patents relate to the lack of disclosure of the origin of the plants used for the invention, and the fact that often traditional knowledge (TK) is not mentioned in patent applications. Other concerns relate to patents that have been taken on existing resources, not showing any innovation, including in relation to TK, and often with very broad claims on natural ingredients.

There is a need for awareness-raising, she said. UEBT found that it is important to reconsider the role of patents, and develop patent policies and criteria for patent use. UEBT developed principles on patents and biodiversity, based on CBD objectives and principles, which recognise that patents need to support the CBD objectives.

Universities Should Identify and Protect IP, WIPO Says

Yumiko Hamano, senior program officer in the World Intellectual Property Organization  university initiative program, described the importance of patenting the results of university research. Universities’ main goals used to be education, generating new knowledge through research and transferring this knowledge to the public. Now they have additional roles, she said, including research funds management, evaluation of technology, due diligence, licensing negotiation, IP training for researchers, and administration of institutional IP policy, she said.

Universities should identify, protect, manage, and profit from IP rights in all areas of IP, Hamano added. Patents, she said, stimulate research and development, attract industry partners for the commercialisation of research results, provide incentive and recognition, and enhance the reputation of universities.

However, she said, there is still a patent divide in patents filed by universities, with the majority of patents being from OECD countries. Major challenges to commercialising research and development include the lack of IP management infrastructure, the lack of funds for IP protection, lack of business and marketing skills, and a gap between basic research and market needs. The WIPO University Initiative Programme adopted in 2002 assists universities in building IP and technology management capacity, she said.

Other experts were Padmashree Gehl Sampath, chief of the Science and Technology Section, Division on Technology and Logistics at UNCTAD, speaking on open science and the freedom to operate, and Johanna von Braun, attorney-at-law for Natural Justice, an international non-governmental organisation working on environmental and local communities issues, who presented cases of misappropriation of genetic resources and associated traditional knowledge, and challenges to prevent that misappropriation.

In particular, von Braun advised that contracts should be drafted well enough to ensure certainty on what happens to the resources when they leave the country. She said local communities need capacity building in order to become real players aware of their rights to be able to negotiate.