By Brian Johnson & Ruth Marsden - 26th November 2012
Without adequate patent protection there would be no innovation. It's arguably one of the ironies of this debate that the patent system has made possible the medical advances we see today. But it's also often the first to be attacked, even though there
We need to protect IPR as this is vital for the long-term development of new medicines. We also need to improve research and development financing to address those diseases which disproportionately affect people living in developing countries
As in all policies it ends up as being a matter of balance as we have two interests at stake here
Pedro Velasco Martins
It’s not just the government that's pushing for compulsory licensing, it’s also because these companies are applying for compulsory licences to the government, so there is a big profit motive that’s also driving this infringement
Pharmaceutical patents and intellectual property rights are part of the solution rather than the problem when it comes to improving access to medicines in developing countries, a Parliament Magazine roundtable has heard.
The event, held last week in the Brussels Press Club and organised in association with Bayer, was hosted by Irish MEP Gay Mitchell.
Mitchell highlighted the need for what he called a balanced approach to the issue of intellectual property rights (IPR) of pharmaceutical companies while ensuring that essential medicines are made available to the world's poorest countries.
"In my case I have to try to balance my concern about the need to preserve good business practice and jobs with the need to be compassionate and to supply drugs and medicine to the third world at a rate that they can afford," said Mitchell who is the EPP group's joint coordinator on parliament's development committee.
"There have been many innovative and groundbreaking achievements in global public health since the start of this century and this has been largely due to the increased and timely delivery of medicines to the most needed populations around the world."
"We need to protect IPR as this is vital for the long-term development of new medicines," he argued, adding that, "We also need to improve research and development financing to address those diseases which disproportionately affect people living in developing countries.
"Over the last decade, efforts to ensure adequate research and development in new medicines and better treatments for the needs of developing countries have been insufficient and remain low on the political agenda of governments worldwide," he warned.
The event, entitled 'Access to medicines: are patents the real barrier?' heard from Andreas Fibig, the head of Bayer's pharmaceuticals division. He began his remarks by stressing that all too often, the issue of patents and access to medicines is seen in simplistic terms.
"Discussing access to medicines almost inevitably generates a heated debate. We often see very divergent views expressed and strong emotions on display. There are good reasons for this; the right medicine can be the difference between life and death or can turn a life threatening illness into a manageable chronic condition," said Fibig.
"However, improving access to medicines does not take place in a vacuum, and it's not a matter of just doing away with patents."
At least 95 per cent of medicines on the World Health Organisation's essential drugs list are 'off-patent', he added. "Yet according to a UN report published last September, essential medicines remain unaffordable and insufficiently accessible to the poor. So the question we need to ask is why?"
Access, explained Fibig, is influenced by several factors, including proximity and availability of medical facilities, the number of trained staff and the absence of health insurance systems.
Fibig said that across Asia, several emerging economies such as China, India and Vietnam have already set ambitious targets in a bid to achieve universal healthcare coverage. "China already covers 90 per cent of its population with basic coverage and they just started five years ago. But already they are faced with the same challenges others are struggling with: an ageing population and the resulting pressure on costs."
Access to healthcare
The rise in non-communicable diseases, often viewed as a problem mainly affecting western economies, is now having a significant impact on developing and emerging countries. "While many of these diseases can be addressed with off-patent medicines or lifestyle changes, in all too many countries what we are not facing is an issue of access to medicines but access to healthcare."
Fibig told participants that the debate on the issue of access to medicines focused too heavily on the issue of intellectual property, pharmaceutical patents and drug prices.
Too often he said, "The blame is laid at the door of the pharmaceutical industry. Some will argue that the industry abuses the patent system while others will go so far to suggest that pharmaceutical patents are the sole cause of insufficient access.
"Patents are not the cause of the high price of new medicines. The cost of researching and developing new medicines is a fundamental factor underlying the fact that new and innovative medicines command higher prices than other treatment."
According to Fibig, the development of a new pharmaceutical product now costs around €1bn. Patents are the means that provide the financial incentive needed for pharmaceutical development to take place. "Without adequate patent protection there would be no innovation. It's arguably one of the ironies of this debate that the patent system has made possible the medical advances we see today. But it's also often the first to be attacked, even though there is no other sustainable alternative.
"However, we would however not be here today if we did not believe that there is a clear need for industry to play an active role."
Patient access and differential pricing
Improving access to medicines, including innovative ones, can take several forms said Fibig, including patient access programmes that offer free or discounted drugs, and differential pricing which offers the same drugs at different prices.
"Patient access programmes allow access to needed medicines and treatment at very reduced prices or even free. But we know that even free doesn't always translate to universal access. In fact, free can still leave a majority of those who need a drug without access." He added that the pharmaceutical industry cannot unilaterally solve the access issue because it's not the sole player involved.
"Lowering prices can only work if many other challenges are addressed and other stakeholders do their part. While lowering prices alone isn't a solution, it would be false to assert that prices do not play a role in limiting access. I am convinced that industry bears a responsibility to make old and new innovations accessible to as many as possible."
Need for a balanced approach
Pedro Velasco Martins, deputy head of the public procurement and intellectual property unit in the European commission's trade directorate agreed with Fibig that, "the real problem is access to health."
The EU has sought ways to improve access to badly needed medicines in third countries he said. "But as in all policies it ends up as being a matter of balance as we have two interests at stake here."
"We have an interest in having access to the most advanced pharmaceuticals, to have the best research and we need to finance that of course, so the system needs to be encouraged and one mechanism to do that is through the patent system. It's not the only one, but it's one that over the years has proven that it works. And of course while doing this we also want to keep pharmaceuticals accessible in terms of price.
Velasco Martins also agreed that the issue was both complex and emotive. "I've participated in some very emotional events and meetings and the temptation to oversimplify the issue is always present. Extreme arguments such as 'patents kill' are, perhaps, the biggest example of oversimplification. But this argument has gained some weight and you hear it being used often. But our view is that this is far too simplistic a view."
The issue of patents and IPR hit the headlines again earlier this year following a decision by India's controller general of patents to issue the country's first compulsory licence to a local generic drug producer to manufacture and sell a generic version of a patent-protected renal and liver cancer drug.
Compulsory licensing, a provision under the trade-related aspect of intellectual property rights (TRIPS) agreement, allows governments to issue a license to a third party to manufacture a patented drug without the consent of the patent owner, under certain conditions. However, the pharmaceutical industry has major concerns that compulsory licensing is open to abuse and that its routine use by governments will put long term pharmaceutical research at risk.
Raja Shankar, a strategy consultant specialising in pharmaceutical pricing and access policy for the IMS consulting group, was the third speaker. He told participants that the risks to patent protection have been increasing in emerging markets and developing countries over the last decade. In addition, it is now spreading beyond the big three developing country diseases such as HIV, malaria and tuberculosis.
"Most of the compulsory licensing or patent infringements were in the HIV area or the so called developing country diseases, but now it's spreading to oncology and also, to some extent, to other areas," said Shankar.
"It's not just compulsory licensing, there are other forms of patent infringement where either patents are not granted or where they have been granted but then revoked, so this is a growing problem and not just in India.
Shankar said that the forces driving patent infringement were concerns over access to medicines and the profit motive from generic companies. "This is why we are seeing more of this happen in India than in any other country, because it has a large generic company presence. It's not just the government that's pushing for compulsory licensing, it's also because these companies are applying for compulsory licences to the government, so there is a big profit motive that's also driving this infringement."
Shankar further warned that the biggest patent risk in the future will lie in oncology treatments. "We have already started seeing this. It's not rocket science, you can see that oncology is actually a much bigger killer in developing countries than HIV by far, with more than 80 per cent of deaths due to cancer happening in developing countries."
A perfect storm
"The products here are really expensive and out of the reach of everybody even if they are middle class, unless they have some kind of insurance, so this is one area where there is a potential for a perfect storm on patent protection."
He believes it is an "absolutely imperative" to address the access issue, "because without addressing this you cannot address everything else. The argument that you need IPR protection to enable future innovative treatments doesn't work for people who don't have access to current treatments."
"However it's not really the pharma industry's responsibility to address access. They are one important player but there are so many different dimensions and barriers to access that it needs a multi-stakeholder approach. I believe the most important stakeholder is the local country government because it's their responsibility to ensure access to healthcare to their population.
Agreeing, Andreas Fibig said that as the issue of unmet medical need grows, "patents are not the problem; they are part of the solution. The pharmaceutical industry and Bayer can and should do more but this is only possible if a number of safeguards are in place."
He added that the industry wants to be a responsible partner in the healthcare debate and was willing to discuss with governments and stakeholders to find ways to expand access while securing conditions that make future R&D possible.
"Ultimately. all these elements will require that a collaborative approach be taken with the right incentives provided to guarantee innovation while ensuring greater access to lifesaving or heath-promoting medicines."