This article is of interest to patients and those concerned about how the TPPA will affect public health and medicine in Malaysia. Access to medicine in Malaysia will be affected by stronger intellectual property rights, and patients can expect high medicine costs for longer. We will also cover some basics on intellectual property rights.
This series is brought to you by TPPDebate.org based on a recent NGO briefing on the Trans-Pacific Partnership (TPP) in Malaysia by Ms Sanya Reid Smith, an expert on Trade and Investment Rules. She has been monitoring the Trans-Pacific Partnership Agreement (TPPA) since 2011, and is also the resource expert for Bantah TPPA Malaysia. The entire talk is uploaded on YouTube in a seven part series and can be accessedhere; this article is drawn mainly from Part 3 of the talk.The index of the series is attached at the end of the article.
What are intellectual property rights?
Intellectual property includes things like patents on inventions: on a new medicine, on a rocket, on a spaceship. It includes things like copyright: on textbooks, films, music.
Generally in the TPP, the US is the net intellectual property exporter, they have the Hollywood industry, the book publishing industry, the multinational pharmaceutical companies, so if the intellectual property protection goes up, the benefits flow to the US. Malaysia is a net intellectual property importer. Most countries in the world are: Australia, New Zealand, all of them are net intellectual property importers. In Malaysia, 90% of the patents granted are to foreigners, or foreign companies. So if we have longer patents, stronger patents, 90% of the benefits go offshore, to the foreigners. These are outflows of money, royalty payments that affect your balance of payments.
Generic medicines are safe and much cheaper
So, what does the TPP say? Malaysia and the other TPP countries are already members of the World Trade Organization, which already requires patents on medicines for 20 years. So that’s 20 years before you can have the cheaper generic version of the same medicine.
So if you think about Panadol, it’s made by Glaxo, but the patent finished a long time ago. So you can get paracetamol, the same chemical, made by another factory, like Hovid in Malaysia, or some Indian factory, with a slightly different name, right? Like Panalol or something. Exactly the same medicine, works the same for headaches, just as safe, just made in a different brand.
HIV: generics cost $67/year compared to $15,000/year for patented
Basically, for example for HIV AIDS, when the medicines were patented, it was a monopoly, right? The patent is a monopoly, no one else can make or import the medicine for the 20 years, so he can charge what price he likes. For HIV AIDS, it was USD15,000 per patient per year, for 20 years. Then the patent finishes, and he can have generic competition from other companies, same medicine with a different brand. The price fell to USD$67 per patient per year. So you can see it’s a big difference in price and affordability when you get the generic competition.
The TPP basically says: more things can be patented, the patents can last for longer, if the Malaysian Government is too slow in giving the patent, or too slow in approving the medicine as safe.
Under TPP, biologics will be restricted for 5 years
And even when there’s no patent, there’s another monopoly of 5 to possibly 8 years. And this is specially for the new medicines called biologics. This is your cancer medicines, your vaccines, your insulin, ebola serum etc. These are all biologics, complex medicines.
And biologics, actually, our science is not advanced enough to make it from scratch. For those of you who remember your chemistry or biochemistry, basically it’s like a protein. I cannot sit here and design a protein on my laptop and make it and print it and fold it and make it work. I start from something naturally occurring. Like insulin, we took it from a pig, then we made a synthetic version of it in the lab. Or human growth hormone, comes from human blood. So basically we start with a natural thing, and we maybe tweak it a bit, or we use the actual natural one, this is a biologic.
So those naturally occurring things should not get a patent, because patents are only for inventions. I shouldn’t get a patent for a leaf that I picked up from the ground, I must invent something new. So often biologics should not get a patent. So you can get the generic version immediately. But now, with the TPP, for 5 years you cannot get the generic version, even when there’s no patent. And these biologics can be more than USD500,000 per patient per year at the monopoly price. For five years.
Ministry of Health cannot afford the medicines
What we already know is that the Ministry of Health in Malaysia already cannot afford to subsidise all the medicines Malaysians need. Some of you may have already found out that for certain cancer medicines, the family has to pay from their own pockets. Certain HIV medicines, second line medicines, you have to pay from your own pockets. So already the Ministry of Health in Malaysia cannot afford to subsidise all the medicines that Malaysians need, let alone with the TPP, when we have high prices for longer, before we can get the cheaper generic version.
So we look back to the Malaysia-US free trade negotiations in 2007, under Prime Minister Abdullah Badawi. He was facing the same demands for stronger intellectual property protection. At that time he said ‘no’. ‘Not suitable for Malaysia. We need affordable medicines.’ What has changed between 2007 and 2015? Suddenly all Malaysians can afford medicine prices of US$500,000 per patient per year? No problem lah? What has changed that suddenly makes it ok today to agree to something that was not ok in 2007 because it was unaffordable for Malaysian patients and for the Malaysian Government, the Ministry of Health? Yet somehow today the same thing is ok, with the current Prime Minister.
Stronger IP protection violates rights of the child
For those of you who look at the human rights impact, the UN Special Rapporteur on the right to health, has said that developing countries should not agree to this stronger intellectual property protection, because it violates the right to health. Malaysia of course has signed very few human rights treaties, but one of them is the Convention on the Rights of the Child, which includes the rights to health.
And in fact, when Abdul Gani, [back then] the Attorney General – was called up before the Geneva Committee on the Convention of the Rights of the Child, during the Malaysia-US free trade agreement negotiations – he was asked: ‘How can you agree to stronger intellectual property on medicines against your obligations on the rights of the child?’ And he said: ‘Don’t worry, I understand, it’s a big problem, we will not agree to stronger intellectual property on medicines.’ He told the committee in the UN. But now of course there is a different Attorney General as well.
Index of the Series
This series contains 20 articles on the TPP, and can be read in any order:
- TPP Basics
- Before signing – the negotiation process
- After signing – ratification and certification process
- What-ifs – if we do not sign, or violate the agreement, or withdraw
- Investment Chapter/Investor State Dispute Settlement (ISDS) – what it means for the country
- Export Taxes on Goods – may restrict Malaysia’s movement up value chain
- Liberalisation of services – is binding across all levels of government (federal, state and local)
- TPP Stakeholders
- Taxpayers and citizens – who will pay for lawsuits against Malaysia
- Business owners and investors – local businesses and Malaysian investments overseas
- Students – intellectual property rights in education
- Patients – intellectual property rights in medicine (patients)
- Farmers – agriculture and food security
- TPP Impacts
- On sovereignty – regulation, colonisation, ISDS
- On governance – different levels of government (federal, state and local), corruption, separation of power
- On economy – trade balance, GDP
- On environment – environmental regulations and the environment chapter
- On society – human rights, labour, privacy
- TPP Miscellaneous Topics
Transcriptions are kept chiefly ad verbatim, with some minor edits for readability. The text has also been checked by Ms Smith for accuracy.