Biologics is the future of medicines, and PhRMA is preparing for the next wave of IP to suit the changing medicines landscape. ....that it is based on the idea that maximalist IP is needed to drive innovation of new medicines. Unfortunately, most of the public health exceptions interred in today’s trade agreements are... difficult for governments to employ in protection of their public health policies. This is because these exceptions require that the public health measures in question be ‘not more trade restrictive than necessary’ or that they are not disguised barriers to trade. The assertion that trade as is does not trump public health is disingenuous and the new biologics market exclusivity provisions indicate a new and perilous trend... to delay entry of biosimilars into the market
by Fifa Rahman*
Policy Consultant at Malaysian AIDS Council
Maximalist Machinations in the TPP: an Illustration with Biologics
On Wednesday, the 6th of March of 2013, the Grand Copthorne Waterfront Hotel in Singapore was bustling with the movements and voices of TPP negotiators from 11 countries, as well as representatives of multinational corporations and civil society. The 16th round of TPP negotiations was underway, and on this day was a break for negotiators to attend lecture style presentations from stakeholders, and later for chief negotiators to sit on a stage in alphabetical order, and provide superficial updates to enquiring stakeholders.
Stakeholders were given rectangular tables in two rooms to set up propaganda materials, with corporations like Google, Visa, and several big seed companies habituating the larger room, and civil society stakeholders working on environmental protection, internet freedoms, and access to medicines occupying the smaller one.
Rumours had just begun of a 12-year biologics provision in the IP text to match. The IP text leaked at that point had no mention yet of biologics. The next leaked text as we now know contained a placeholder for biologics, and the final IP leak contained the ambiguous 5 or 8 years of market exclusivity for biologics.
A fellow activist from the Kuala Lumpur-based Breast Cancer Welfare Association had been particularly concerned, and approached a number of negotiators to emphasise the impact on access to cancer medication. After the chief negotiator briefing, a tick-the-stakeholder-consultation-box fallacy during which non-answers were frequent and spewed without hesitation, this activist approached the US Chief Negotiator Barbara Weisel, with pleas on behalf of breast cancer patients. In response to this, Weisel took his hand in hers, and told him that her mother was a cancer survivor, and that she understood. Later during the Kota Kinabalu negotiation round, Barbara Weisel would, in response to my query, state that there was a need to find the ‘golden balance’ in IP.
The problem with the quest to find the ‘golden balance’ is that it is based on the idea that maximalist IP is needed to drive innovation of new medicines. In addition, this claim that negotiators were looking to find the golden balance, was uttered on the cusp of US negotiators tabling 12 years of market exclusivity for biologics medications – which include several blockbuster cancer drugs like Herceptin for breast cancer, insulin, and several vaccines, and other provisions that would delay entry of generics into markets and reduce transparency on pharmaceutical R&D costs. The disingenuous statements continued right to the signing of the TPP on 4 February 2016, where a number of Malaysian politicians, including the Minister of Health and the Minister of International Trade and Industry, claimed that as far as IP is concerned, it was status quo for Malaysia. This claim was centred on the fact that Malaysia already has 5 years data exclusivity, and the 5 years exclusivity for biologics in the TPP mirrored that. Naughty, given that the Malaysian law provided for data exclusivity and the TPP provided for market exclusivity, which in reality could run consecutively, delaying access to generics even further.
A tool that IP maximalists claim will contribute to the golden balance is the public health exception within these trade agreements. Most recently, at the Global Dialogue for the UN Secretary-General’s High Level Panel on Access to Medicines in Johannesburg on 17th March 2016, Roger Kampf, Counsellor in the Intellectual Property division of the World Trade Organisation (WTO) referred to the public health exception and stated that these prove that trade does not trump health. Unfortunately, most of the public health exceptions interred in today’s trade agreements are a variation of the GATT XX exception, which is notoriously difficult for governments to employ in protection of their public health policies. This is because these exceptions require that the public health measure in question be ‘not more trade restrictive than necessary’ or that they are not disguised barriers to trade. (Shaffer et al. 2005)
The assertion that trade as is does not trump public health is disingenuous and the new biologics market exclusivity provisions indicate a new and perilous trend. While some academics disagree strenuously with me, the introduction of IP provisions specific to biologics does not merely represent a change from HIV activism to cancer activism, although this in itself, in my view, is significant. Biologics is the future of medicines, and PhRMA is preparing for the next wave of IP to suit the changing medicines landscape.
Because market exclusivity is so new, there isn’t yet a lot of research on it. A recent study on market exclusivity in the U.S., however, found that ‘a uniform increase in the minimum period of regulatory exclusivity would disproportionately benefit drugs that are likely to be of less clinical importance’. (Wang et al. 2015) It should also be noted that data exclusivity and market exclusivity are different – and that they have run at different times for the same medicine. (Teva v European Medicines Agency) This means that they can be used as a tool to delay entry of biosimilars into the market.
Some have claimed that biosimilars take 13-16 years to come to market anyway, so a 12-year exclusivity shouldn’t get activists’ panties into a knot. But as technology transfer happens and biosimilar companies get better and better, this time will get shorter. So while the provision may seem rather docile now, biologics market exclusivity has the potential to grow into a much more menacing monster. All should care about this because the TPP is the model for future trade agreements, and that monster will eventually manifest itself in the form of a negotiator, ready to take a patient’s hand in hers, telling him he understands.
* A deadline-oriented public health policy professional and strategic advocate with 7+ years of experience in HIV and HCV, with a focus on drug policy reform, access to affordable medication and intellectual property, anti-discrimination policy, and qualitative research on women who use drugs, and 2+ years of experience in tobacco control. Co-editor of the 2013 book Drug Law Reform in East and Southeast Asia. Alumnus of the U.S. Department of State International Visitor Leadership Program (IVLP) (individualised) on HIV, Pharmaceuticals, and Global Governance. https://www.linkedin.com/in/fifa-rahman-6ba2ab2a
Related link: TPP: Up with Corporate Profits Outweighing Equity in Health! http://www.peah.it/2015/11/tpp-up-with-corporate-profits-outweighing-equity-in-health/