Bilateral agreements and TRIPS+

Within the framework of these agreements, clauses going far beyond the WTO minimum standards (TRIPS) are systematically negotiated by Switzerland. These clauses jeopardize access to medicine for poorer populations by delaying the arrival on the market of more affordable treatments (generics).

Problems caused by TRIPS+ provisions

The TRIPS+ provisions systematically negotiated by Switzerland for its pharmaceutical industry include the extension of patent terms, the exclusivity of clinical trial data used for the approval of drugs (in short: data exclusivity) or the protection of the investments made by multinationals in this country.

The extension of patent terms beyond the 20 years provided for by the WTO generally involves granting supplementary protection certificates (SPCs) to patent holders at a national level. They extend the term of a product’s protection by several years, supposedly to compensate for the time it takes to process the patent application – a long-standing requirement from the pharmaceutical industry to expand its monopolies. Although they are common in Europe (an extension of up to five years in Switzerland), neither the TRIPS Agreement nor the legislation of low- and middle-income countries provides for such supplementary protection certificates being granted.

A data exclusivity provision enables pharmaceuticals multinationals to systematically prohibit the national drug regulatory authorities from using the data from their clinical trials to authorize an equivalent generic product. This would apply for several years after the launch of their product (in Switzerland, for example, this period is set at a minimum of 10 years). While the TRIPS Agreement provides for the protection of such data against “unfair exploitation”, it contains nothing that stipulates total exclusivity, a duration for or a ban on the use of such data in the context of approving generics,  the latter being an integral part of the principle of competition.

It should be noted that this provision is not linked to the status of patents but that it grants additional exclusive protection to pharmaceutical multinationals, further delaying the arrival on the market of affordable (generic) medicines. Moreover, it poses an additional obstacle in the event of compulsory licensing – which only affects the patent monopoly, and not data exclusivity – preventing the approval of a generic version throughout its period of validity.

In its free trade agreement with India, Switzerland has finally (for the time being) given up on a data exclusivity provision – even though it tried to include it from the start of the negotiations in 2008 and until the very last moment. In many other countries, such as Ukraine and Chile, this provision is definitely included in the FTA in force, with very specific, damaging consequences in terms of access to more affordable medicines.

As part of its FTA negotiations, Switzerland is also seeking to weaken the TRIPS flexibilities and public health safeguards to fight against abusive monopolies provided for by low- and middle-income countries with a strong generic industry, such as India, Thailand, Argentina or Brazil (Mercosur). These limitations also have negative consequences for access to medicines and public health in these countries and should therefore also be considered as TRIPS+ provisions. 

The procedures that Switzerland is seeking to undermine are: 

Oppositions to patents prior to them being granted (“pre-grant oppositions”). Only a dozen countries, mostly low- and middle-income countries such as India and Thailand, use this legal flexibility enshrined in the WTO agreements. Such procedures are not foreseen in Switzerland or in most other wealthy countries in Europe, North America or Asia, which only provide for opposition proceedings once a patent has been granted. Swiss pharmaceutical companies have, in the past, broken their teeth several times on these pre-grant patent oppositions. Starting with the symbolic case involving Novartis’ cancer drug Glivec, which had its patent refused by the Indian authorities at the end of a long legal saga. 

Switzerland is seeking to undermine these opportunities to intervene at an early stage of the patent granting procedure wherever they are present, as it did with India in its bilateral FTA concluded in March 2024.

The use of compulsory licensing to remedy the lack of exploitation (or working) of patent(s) is also often targeted by Switzerland/EFTA in its FTAs, even though, to varying degrees, there is a requirement in the majority of national laws to commercially exploit a patent in the country where it was granted and to report to the relevant authorities. The working requirement is in order to prevent patents from being obtained without the intention of supporting the local economy. For low- and middle-income countries, this requirement is seen as a means of strengthening local production and as a counterpart to their efforts to harmonize the granting of patents on pharmaceutical products at a global level (WTO TRIPS standards). However, many pharmaceutical multinationals do not (or no longer) necessarily manufacture locally but import the patented product, which is perceived by some countries as a lack of exploitation of patent(s) motivating the use of TRIPS flexibilities such as compulsory licensing. India, for example, has activated this mechanism for this reason in the past.

By weakening patent working requirements through their FTAs, as they did for example with India (March 2024) or Indonesia (December 2018), Switzerland and EFTA are reducing the room for manoeuvre of low- and middle-income countries to fight against patents that do not sufficiently benefit the local economy and are blocking the way to more affordable generics in these markets.

Limited TRIPS exemption for the poorest countries

Lastly, another examples of a TRIPS+ provision is the reticence of rich countries, including Switzerland, to grant Least Developed Countries (LDCs) a permanent exemption (waiver) without any conditions from (1) applying the WTO’s intellectual property rules and (2) patenting medicines – whereas everyone recognizes the special status of these 44 poorest countries in the world. After several hard-won renewals, LDCs are exempted from granting pharmaceutical patents until 1 January 2033 and from protecting intellectual property (application of the TRIPS Agreement in general) until 1 July 2034. 

When the pharmaceutical industry says that it will not apply for patents in the poorest countries, suggesting that it is carrying out a charitable and responsible act, it is only a PR stunt since LDCs are legally exempted by the WTO from issuing them.