PHARMACEUTICAL INDUSTRY IN EUROPE
5.3.4 The International Level
Part of EFPIAʼs lobbying activities also includes contacting high-ranking officials. For instance, in June 2000, during its annual meeting, EFPIA hosted the President of the European Commission, Romano Prodi, as its guest of honour.87 The link between IPRs and access to medicines in developing countries was one of the issues discussed at that meeting. Expressing the industryʼs position on that matter, EFPIAʼs president, Gallardo, argued that ʻit is important to understand that reducing IPRs is not a solution to the issue but exacerbates the problem and potentially encourages the dangerous use of counterfeit medicinesʼ.88
Finally, European lobbying by EFPIA also proved highly effective in other areas such as price regulations, control over the supply of information to physicians and consumers, and the granting of marketing approval to new drugs.89
EFPIA is thus one of the most important and effective IP representatives of the advanced pharmaceutical industry in Europe. It incorporates national associations and pharmaceutical MNCs as members, allowing the latter to maintain a high level of dominance, influence and voice. EFPIA also has a key role in devising the industryʼs IP objectives and strategies. Moreover, to date (2000) decisions concerning European IP-related policies and objectives (both internal and international) are subject to a complex process in which authority is shared both by the European Community and by its member states.
In practice, bodies such as the Commission and the Council of the European Union play a decisive role in the European IP decision-making process. That in turn requires EFPIA to operate directly at the regional level in order to secure a more favourable environment for research-based companies. As previously shown, and as will be discussed later, EFPIA was able to carry out its IP duties in a highly organized, efficient and effective manner, especially during the 1995–2000 period.
of IFPMA, developing position papers on various policy issues (including IPRs) and representing its members vis-à-vis major international non-state actors.
To date, the IFPMA enjoys official consultative status with the following agencies: World Intellectual Property Organization (WIPO); World Trade Organization (WTO); United Nations Industrial Development Organization (UNIDO); United Nations Conference of Trade and Development (UNCTAD);
United Nations Economic and Social Council (UNESCO) United Nations Childrenʼs Fund (UNICEF); World Health Organization (WHO); and the Council of Europe.90
National and regional associations are members of IFPMA, which represents research-based pharmaceutical MNCs and other manufacturers of prescription medicines from developed and developing countries. In 2000, IFPMA had 53 national and regional member associations.91 The IFPMA assembly is responsible for the admission of new members, the creation of IFPMA codes of practice, and for the formulation of its policies.92 Members of the IFPMA Council are directors of national associations and CEOs of research-based companies.93. The US, the UK, Germany, France, Italy and Switzerland are permanent members of the Council.94
IFPMA activities are guided by its various advisory committees such as those dealing with patent protection (Intellectual Property Protection Coordination Committee), international economics (Advisory Committee on Trade and Economics) and biotechnological products (Biotechnology Committee).95 Ad hoc groups are also convened when necessary to undertake specific tasks such as preparations for multilateral trade negotiations (Seattle WTO ministerial meeting, December 1999).96 IFPMA has four main areas of activity: (1) public/
private partnerships; (2) IP protection; (3) research, development and innovation, and (4) information and marketing.97 Not dissimilar from its sister organizations at the national and regional levels, the IFPMA attaches great importance to the protection of IPRs:
A viable research-based pharmaceutical industry operating in an open market – with adequate and effective protection of intellectual property in line with other industries and with regulatory policies designed to ensure the rapid introduction of new chemical and biological products – is essential to patientsʼ well-being and to the economic development of all countries around the world.98
The IFPMA focuses on three IP elements in particular: the protection of patents, IP protection under the WTO TRIPs Agreement, and the prevention of counterfeiting.99 The IFPMA has, by virtue of its official NGO advisory status, an important role in transmitting the IP requirements of research-based pharmaceutical MNCs to decision makers and key bureaucrats. It is also a vibrant and effective producer of position papers, reports, booklets and newsletters focusing on the need for strong IP protection. For example, between 1995 and
2000, IFPMA published titles such as ʻGATT TRIPs and the Pharmaceutical Industryʼ (1995), ʻThe Questions of Patents – The Key to Medical Progress and Industrial Developmentʼ (1998) and ʻParallel-Trade: A Recipe for Reducing Patientsʼ Access to Innovative and Good Quality Medicinesʼ (2000).
INTERPAT
Unlike the IFPMA, which operates as an official representative of the industry on a wide range of issues, INTERPAT is a much more specialized forum representing only members of research-based pharmaceutical companies and focusing solely on IPRs.100 Its main objective is to
provide an international forum for fostering improvement in the field of international intellectual property law with respect to pharmaceuticals by advocating government actions to improve, strengthen and harmonise intellectual property regimes throughout the world and supporting the mutual exchange of information among its members regarding technical developments and legal practice in said field.101
INTERPATʼs organizational structure consists of six major units (1998): the General Assembly, Country Groups, the Liaison Group, INTERPAT President, IPR Work Groups and the Treasurer.102 The General Assembly is in charge of admitting/dismissing member companies, forming working and country groups, electing INTERPATʼs president, and so on. 103 INTERPATʼs Liaison Group functions as its managing board, coordinating and facilitating its activities.104 Most important are INTERPATʼs working groups, dealing with specific IPR topics relevant to research-based pharmaceutical MNCs.105 Designated tasks include issues such as biotechnology, the protection of IPRs in different countries and regions (Canada, India, China, Mediterranean), international exhaustion, effective patent life, registration know-how (data exclusivity), trademarks and so on.106
Operating as a specialized forum for IPRs, INTERPAT enables pharmaceutical MNCs from different home-based countries to communicate directly with each other and, as a result, to feed inputs to their representatives from the national, regional and international levels. Furthermore, not only does INTERPAT deal with issues under consensus, it also strives to resolve tensions arising from different national laws. A notable example is the difference between the US, Europe and Japan (as well as other countries) regarding priority conflicts in patent grants. The US uses a system known as ʻfirst to inventʼ, tracing priority on the basis of inventive activities, while Europe and Japan use a system known as ʻfirst to fileʼ, based on the date of the patent application. Non US-based companies, including pharmaceutical ones, argue that the first to invent system is discriminatory, as it does not rely on activities which took place outside US borders when tracking priority invention dates (Section 104 of the US Patent Statute). 107 Despite the political reality that does not currently allow change
in the US patent statute, INTERPAT did express its support for the European mode of patent application. Following INTERPATʼs meeting in October 1991, one of its senior members commented that the US first to invent system is out of line with the first to file system used in the rest of the world, and leads to discriminatory treatment against non-US inventors.108
By using forums such as the IFPMA and INTERPAT, pharmaceutical MNCs are able to expand their IP organizational structure internationally.
Much broader in scope, the IFPMA uses its special consultative position with international institutions such as the World Bank, WTO and WIPO in order to promote awareness of the IP demands of pharmaceutical MNCs. In addition to its lobbying activities, the IFMPA is one of the most dominant information providers with regard to IPRs. INTERPAT is a much more consolidated forum focusing specifically on IPRs. Given that INTERPATʼs membership is restricted only to pharmaceutical MNCs, its role as an international intra-industry forum for IP consultation is pivotal. It allows companies to submit much more coherent input to their representatives at the various levels of lobbying activities and to resolve tensions arising from different legislative environments.