The US government's intentions and aims in advocating stricter intellectual property (IP) measures through a free trade agreement (FTA) with Malaysia have been "misperceived", claimed a US senior official.

Attorney-Advisor at the US Patent and Trademark Office, Karen M Hauda, said the US wants stronger IP protection regulations in Malaysia for pharmaceutical products, patents and clinical tests data.

However, implementation of such measures will not necessarily translate to higher medicine prices, the folding-up of the local generic medicines industry, or prevent Malaysia from effectively tackling public health issues such as HIV/Aids, she said.

According to Hauda, there is little empirical evidence from the track record of countries that have signed FTAs with the US to substantiate fears that new regulations will have disastrous consequences on access to medical treatment.

"In fact, there's been very little impact on the cost of medicine overall (as a result of US FTAs)", she told malaysiakini in a recent interview in Kuala Lumpur.

"(Stronger protection of) intellectual property rights are not, per se, increasing the costs of medicine."

Malaysia would benefit from strong IP protection as it will improve investment and the environment for investments in the domestic market which, in turn, will add to jobs in the industry and promotion of technology transfer, she said.

She cited the experience of Jordan which saw growth in clinical research and its domestic new and generic medicines industry after it signed a FTA in 2000 with the US.

There have been 65 new innovative product launches, "a substantial increase in the rate of approval of innovative drugs" that have helped Jordanians gain access to new medicines.

"Before 2000, only once clinical trial was conducted in Jordan. After 2000, 35 trials have been or are in the process of being conducted," said Hauda.

"The generic industry has experienced a significant growth - it is producing and selling more locally and exporting medicines."

Hauda admitted, however, that the FTA with Jordan was one of the earliest bilateral FTAs concluded. So, while available evidence cannot be used to substantiate fears of domestic access to medicine, neither can the fears be allayed.

"We only just concluded the FTA with, for example, the Central American countries. I don't think the impact with respect to the data protection provision and patent protections provisions can be visualised at this point in time with respect to those countries."

Apples and oranges?

Hauda also said Malaysia cannot be compared to South Africa - whose government barely averted a disastrous hike in HIV/Aids medicine through negotiations with the pharmaceutical company.

"I think there's a lot of comparing of apples with oranges in this respect. I'm not sure South Africa has implemented the IP rights provisions that we are talking about, so we can't look at the impact," she said.

She said the US is "a huge supporter" of the fight against Aids, citing the government's US$15 billion five-year President's Emergency Plan for Aids Relief programme to help combat the diseases in more than 100 developing countries.

Also, the FTAs contain specific provisions to indicate that governments are not to be stopped from addressing pubic health needs and taking the necessary measures, including access to medicine.

"It's a misperception of what the US is trying to achieve in the FTA. Looking for strong IP rights does not mean that it's going to impair a country's ability to address its public health measures."

"Those protection measures will, to our mind, give positive benefits to Malaysia, including in the area of pharmaceutical advancement and medicine."

On the issue of patents protection, which the US has been accused of trying to extend from the current 20-year period through FTAs in order to increase pharmaceutical firms' monopoly over medicines, Hauda said the US has again been misunderstood.

The US, said Hauda, is only seeking to extend the term so that companies can recoup losses incurred despite receiving patent protection, due to the long process of obtaining approval for medicines from the health ministry.

"What the FTA is doing is merely looking at when the patent term has been cut unreasonably short due to the approval process mechanism.

"Our proposed provisions are looking to receive some compensation with respect to the patent term for that approval process, because the patent was essentially worthless until the approval was granted."

She noted that this would not only be beneficial to pharmaceutical companies developing new medicines who want to recoup their costs, but to the generic industry which is dependent on the latter.

"The generic industry is also dependent on the innovative industry. You need innovative medicine in order to have new generic medicines. If you don't have new medicines, you won't have new generic medicines either. The process actually benefits innovators and generics."

Asked whether developing countries can acquire any significant gains from IP protection to new technology and product patents, given that advanced countries like the US and their multinational corporations already hold more than 90 percent of all patents, Hauda said "the FTA is not about the past but about the future".

"I strongly believe that, especially with the emphasis that the government of Malaysia seems to want to put in building technological advancement and growth, that the opportunity of being able to receive patents domestically for new technological advances - including in the area of pharmaceuticals - will benefit Malaysia and help it to become innovative in this area."