The Badan Bertindak Bantah TPPA (Bantah) coalition has long warned about the dangerous provisions being proposed for the Trans-Pacific Partnership Agreement (TPPA), the complete text of which has reportedly been finalised recently in the city of Atlanta in the United States.

Based on past free trade and investment agreements that have served as the bases for the chapters of the TPPA as well as on leaked texts that no TPPA government (including that of Malaysia) - had ever denied or confirmed as to their veracity, we have consistently highlighted the harm those provisions could have on Malaysia’s social, economic and political fabric and the welfare, environment, and the interests, welfare and future of her citizens.

We wish to be proven wrong. It is our fervent hope and desire that the fears we have about the TPPA based on the real, actual experiences of countries and communities that have had the same, or similar, legal obligations imposed upon them - not hypothetical cases - are proven wrong when the final texts of the TPPA are revealed to the public.

Whether it is the challenge posed to the integrity and sovereignty of national legal and political institutions, the raising of barriers to affordable medicines and education, restrictions and ownership on the communication of mass as well as private data and information - we wish very badly that those proponents of the TPPA can substantively and definitively allay and lay our fears to rest that the future of Malaysia and the future generations of her populace will not have it worse off as a result of the provisions contained in this deal that our leaders are binding the country to without our free, prior and informed consent.

However, the Oct 9 leak of the final draft of the Intellectual Property (IP) chapter of the TPPA has only served to strengthen the fears we have harboured.

Rather than counter the claims we have made consistently over the past few years regarding the TPPA, the leak of the final draft of the IP chapter last week has only confirmed our position that whatever benefits have been claimed by its proponents - since no evidence from any vigorous and systematic cost-and-benefit analysis has yet to be disclosed despite having been promised two years ago - are far outweighed by the costs of the deal.

Confining ourselves to IP and access to affordable medicine, Bantah and other critics of the TPPA have long and consistently cautioned against agreeing to legal obligations that go beyond what Malaysia and ALL other of the members of the World Trade Organisation (WTO) had agreed to in relation to IP and access to medicines.

The Oct 9 leak prove that negotiators and governments have been directly, indirectly and excessively pressured by big pharmaceutical companies into making a number of changes to those WTO rules that will boost brand companies’ profits by allowing them to charge higher prices for drugs and to keep potential generic medicines out of the market.

Legal rules in the final draft

These changes come in the form of legal rules in the final draft of the IP chapter which includes Patent Term Extensions, Marketing Exclusivity and Patent Linkage. Without exception, Bantah and other groups have warned about ALL of these being included in the TPPA.

In the finalised version of the TPPA’s IP chapter leaked to the public on Oct 9, 2015, it has been shown that what we have warned about have come to be maintained in the TPPA.

(It should be noted that the following are only the main obligations of TPPA governments, and is not a comprehensive layout of the issue of IP and access to medicines in the final version of the IP chapter.) The IP chapter, as the leak (available at wikileaks.org/tpp-ip3 ) provides for:

- Patent Term Adjustment: Article QQ.E.14 of the leaked IP chapter provides for the same mechanism we have warned about, the extension of patents beyond the WTO standard of 20 years, enabling drug companies to press for a patent on grounds of the need to be ‘compensated’ for any ‘unreasonable’ time a national drug authority or patent office takes to examine or approve an application.

As Bantah and others have consistently argued - and many studies have shown - if the drug regulatory authority is not fast enough, such patent term extensions significantly delay the entry of cheap generic medicines into the market and restrict access to affordable medicines.

- Pharmaceutical Data Protection/Protection of Undisclosed Test or Other Data (Market Exclusivity): Article QQ.E.16 of the leaked IP chapter stipulates exclusive rights to be given over test or other data that has been submitted by a drug patent holder to TPPA governments’ drug regulatory authorities.

As we have warned many times, generic companies are empowered by this TPPA provision to prevent for five years, the registration of an equivalent generic version of a patented drug for market approval based on originator company data, thereby curbing the supply of cheaper drugs.

This market exclusivity provision means that while TPPA government authorities can accept generic medicine applications during those five years, they cannot grant the marketing approval before the five years have passed from the date of marketing approval in the country concerned.

Of course Malaysia already has this in its domestic laws - which has various safeguards - while the TPPA locks in this TRIPS-PLUS mechanism (TRIPS-PLUS: mechanisms that go beyond WTO TRIPS agreed to by all WTO members)

- Pharmaceutical Data Protection (marketing exclusivity) for New Clinical Information or New Compounds: Article QQ.16.2 of the leaked IP chapter effectively stipulates that the authorities are to ‘evergreen’ already existing monopolistic patents through market exclusivity (as there may be no patent) if:

1. Option a (at least three years additional exclusivity for new clinical information): a pharmaceutical company has come up with an ‘innovation’ even if the ‘new’ medicine is an old drug that has been found to be useable for a condition other than that which it was originally developed to treat, or for old medicine that has been found to be useable for a different population of patients (for example, children)

2. Option b (at least five years additional exclusivity for new combinations): a pharmaceutical company seeks exclusivity for new combinations of an old drug and a new chemical entity.

- Patent Linkage: Article QQ.E.17 of the leaked IP chapter refers to patent linkaging, a controversial mechanism proposal pushed by branded pharmaceutical companies which links approval by the drug regulatory authority (for the drug’s safety, effectiveness and quality) with the essentially ‘branding’ process of acquiring a patent at the national patent office.

Cumbersome and onerous

Patent linkage has been controversial due to it being cumbersome and onerous for governments (of both developing and developed countries, such as the US and European Union countries) due to the huge material and human resources needed to put the system in place linking what had hitherto been separate aspects of access to medicine.

There had been proposals to exclude ‘biologics’ from patent linkage, but no such exclusion appears in the final draft of IP chapter as leaked on Oct 9.

- Biologics Exclusivity: Article QQ.E.20 relates in the final IP chapter to the Data Exclusivity of the new generation of ‘biologics’ medicines (medicines derived from proteins isolated from plants, animals and micro-organisms) that have been developed to treat human diseases and conditions, such as vaccines, cancer medicines and therapies such as insulin.

The number of years of exclusivity have led to such high prices that even in the US, the Obama administration has repeatedly sought to reduce the number of years of DE in that country from 12 years to seven years.

For the TPPA, US negotiators had pushed for 8 years. The final compromise, as reflected in Article QQ.E.20 of the IP chapter, provides for TPPA countries to provide either five years (market exclusivity counting from the date the biologic is approved in the country concerned) or eight years (from the date the biologic is approved in the country concerned).

We will not spend much time, as proponents of the TPPA insist, on the so-called ‘positives’ reflected in the draft (Footnoted* below for reference), since they exist only because the US started with such ridiculously extreme demands favouring corporate interests, but because they came down a few metres as supposed ‘compromise’, other TPPA governments have been led to praise them.

The overall picture - and the thrust of the main provisions that we have cited above – presented by the final draft of the TPPA IP chapter is that (i) TRIPS-PLUS provisions are the rule rather than the exception and (ii) the few clauses granting ‘relief’ are exceptions to the general structure of rules that effectively choke off affordable access to medicine.

As Bantah has maintained throughout its campaign - and which has been the stand of many governments (including, up until now, Malaysia), organisations and individuals concerned with access to affordable medicines - there should not be any extension of patent terms, data exclusivity, nor provisions stipulating linkage between patent status and medicine registration.

To mention just one such individual, Nobel laureate in economics Professor Joseph E Stiglitz has recently warned that the TPPA locks in the unequal advantages of advanced economy countries is by raising intellectual property (IP) protection in ways that raise profits for intellectual property owners at the expense of everyone else:

The impact of more stringent IP can be seen most clearly when it comes to life-saving medicines. Driven by ‘Big Pharma’ lobbyists, American negotiators are pressing TPPA countries to accept protections that will boost their profits, not from innovating new medicines but by keeping potential competitors out of the market and charging consumers higher prices.

It accomplishes this through a variety of seemingly arcane rule changes - buried in jargon about ‘patent linkage’ and ‘biologics’ - which collectively would allow pharmaceutical companies to extend their monopolies for many more years than they currently can.

Many problems that raise concern

Many others, such as former and current Malaysian government officials and elected representatives as well as United Nations experts and rapporteurs, have criticised the TPPA’s IP provisions.

As mentioned earlier, there are many other problems in the final IP chapter leaked last week that have raised concern that are apart from access to affordable medicine, such as the impact of its farmers and agriculture and the facilitation of biopiracy (by way of signing onto the UPOV Treaty of 1991 and the Budapest Treaty 1977), and impacts on affordable education and the Internet.

In the context of the 1MDB scandal, it is notable that here are even paragraphs that may give TPPA governments greater power to even stop embarrassing information going public and the ability to curb legal proceedings if the theft of information is “detrimental to a party’s economic interests, international relations, or national defense or national security.” In Article QQ.H.8 on Trade Secrets, the IP chapter says:

“With respect to the acts referred to in Paragraph 2, a Party may, where appropriate, limit the availability of such criminal procedures, or limit the level of penalties available, to one or more of the following cases: ... (e) the acts are detrimental to a Party’s economic interests, international relations, or national defence or national security.”

Given the scenario above framed by the provisions we have laid out from just one chapter of the TPPA that has been finalised, we wonder how proponents of the TPPA can still insist on giving the ‘deal’ the benefit of the doubt even before they themselves have seen the agreement.

But given that the government is bound - by US political rules, ironically - to reveal the texts within about 30 days after Oct 5 hen the negotiations over the chapters were reportedly concluded, we do hope our doubts are laid to rest. Indeed, for the sake of Malaysia and her future generations, we look forward to be proven wrong.

* Compromises reached in the final IP Chapter:

- Article QQ.E.14 on ‘patent term adjustments’ somewhat narrows the applicability of extensions from ‘patents covering new pharmaceutical products, methods of making and using pharmaceutical products’ (as contained in earlier drafts of the IP chapter, such as the November 2013 draft) to merely patents covering new pharmaceutical products.

- Article QQ.E.15 provides for a ‘regulatory review exception’ to the general rule of patent term extension (referred to as ‘patent term adjustments’ in Article QQ.E.14), whereby generic drug makers are permitted to make small batches of a medicine when applying for marketing approval before the term of a patented drug expires without risk of liability for infringement. While earlier versions of this provision limited the applicability of regulatory review to domestic/local markets, QQ.E.15 allows such a review for products aimed at ‘foreign jurisdiction’.

- An Annex to the IP chapter in question specifically allows Malaysia to keep its ‘access window’ system, whereby a pharmaceutical company must apply for marketing approval in Malaysia for a new pharmaceutical product, new clinical information/combinations or a new biologic within 18 months after the product is first registered in any other country. Failure to do so would lead to that company forfeiting its claims to exclusivity over that product, information, combination or biologic.

- Article QQ.E.16.3 provides for public health safeguards, whereby TPPA governments can take measures to protect public health in accordance with the WTO Agreement on Trade-Related Intellectual Property Rights (TRIPS) and the Doha Declaration on the TRIIPS Agreement and Public Health. Bantah actually thinks this is a useless ‘positive’, but for lack of substantial positives in the form of health exceptions, we have included it in the list.