NEW YORK – Strong intellectual property rights will be a top priority for the pharmaceutical industry internationally in the coming year and arguments for over IPRs versus medicines access are false, a top representative said at a high-level industry event this week. But views at the event differed on expectations of industry in light of the Ebola crisis, hepatitis C drug costs or other medicines access questions.
A senior World Health Organization official said that while the primary responsibility for health lies with governments, industry should be prepared to accept that sometimes must engage for the global public good.
“We need to be more inclusive,” said Marie-Paule Kieny, WHO assistant director general for health systems and innovation, joining the meeting from a distance. The health system must take care of the needs of all, and the health system of the future needs to take care of outbreaks too, must include infectious threats.
“Of course the primary responsibility is with government,” she said, as they have been elected to take care of the population. But investment has been targeted to specific goals, with inadequate funding for overall health systems. Going forward, there needs to be assurance that sufficient funding is going toward infectious diseases, she said.
Suerie Moon of the Harvard School of Public Health asked whether speakers on a panel saw a need for a more robust system of international rules to ensure that research and development is targeted toward diseases for which there is an insufficient market incentive. Perhaps a treaty on R&D or a fund would be useful, she asked.
Kieny said at WHO they have heard about the lack of a market for drugs causing them not to be developed. It is a “big debate at WHO year after year” that some drugs lack an incentive for development because there is no market.
The debate is how to ensure the drugs and vaccines that are needed are developed, but recognising that industry has a business of its own. So, she said, more investment from governments is needed.
“We all want industry to play a role,” she said, and “they do play a role.” Industry has been “quite exemplary” in response to Ebola, where it is acting with “lightning speed” to develop vaccines.
“You wonder why it was not before,” said Kieny. They should be engaged by the public sector to develop such products, and this should be done with both push and pull mechanisms.
She said in such cases, it may be necessary to go to a model that is not only market-oriented. This may mean these products do not get the same profit margin as latest drugs, she said. An agreement may be needed.
“Industry would have to accept that they would engage but also accept they are doing this as a global public good – but it has social good,” said Kieny.
Jon Pender of GlaxoSmithKline spoke from the audience to downplay prospects of a treaty or other instrument relating to R&D, but he acknowledged that it might not be the best approach to bring market dynamics into cases like Ebola.
He said industry has welcomed the leadership of WHO in the area of neglected tropical diseases, and that even with an R&D treaty, it is unclear how much funding would have gone into Ebola. All known Ebola cases in the past 40 years totalled only 16,000 cases. There are that many cases of malaria every 40 minutes, he said.
“It is not market failure, but lack of leadership,” said Pender. When WHO and leaders show industry leadership, industry responds.
But it is unclear what mechanism is in place for that leadership and coordination on R&D to take place so that another Ebola doesn’t continue to happen in future.
New IFPMA Vision
“Innovation and intellectual property rights are at the core of our industry,” said Stefan Oschmann, member of the Executive Board and CEO Pharma at Merck (Germany), who this week took over as president of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) for two years.
“There is zero evidence that IP is a hindrance to access to medicines,” he asserted. “We feel part of the debate is influenced by industrial policy considerations rather than patient access.” Access, he said at another point, “goes beyond the mere supply and availability of drugs and medicines.” Other speakers also emphasised the point that access to medicines is best calculated as part of the total cost of health, not just the silo of the cost of pharmaceuticals.
“I want to reiterate the importance of strong intellectual property rights frameworks as an enabler for innovation and access,” he said. He cited the “enormous challenges” for global health despite great gains, challenges such as 1.3 billion people with no access to effective and affordable health care, and that fact that more than 96 percent of medicines on the WHO Essential Drugs List are off-patent, “fewer than 45 percent are accessible by patients who need them most, in markets where resources are most constrained.”
But, he said, “It is clear that IP is not the problem but part of the solution.”
Oschmann made the remarks in his inaugural speech at an IFPMA conference on Investing for Healthier Societies: Innovation, Inclusiveness and Sustainability.
At the top of Oschmann’s list of praise for outgoing IFPMA President John Lechleiter, chairman, president and CEO of Eli Lilly, was the organisation’s anti-counterfeiting efforts through the “Fight the Fakes” campaign.
Oschmann views himself as innovation-oriented. “One common theme throughout my career, both in the public and private sectors, has been the creation of environments where innovation can make a difference and how partnerships across different parts of the world can maximize our share potential,” he said.
He said developing countries face a “triple burden” of disease: infectious diseases, non-communicable diseases, and problems associated with globalisation, such as pandemics, pollution and climate change.
As IFPMA president, he will focus on two initiatives, he said: “Stimulating sustainable innovation through local entrepreneurship through recognition and promotion of tomorrow’s health innovators,” and “strengthening, scaling and fostering capacity building through local empowerment. He said innovation is complex and not only a measure of R&D dollars spent.
On another point, he said it is “equally naïve” to think people in the pharmaceutical industry are only motivated by profit as it is to assume people in the public sector are only driven by the public interest. He steps into the role with a focus on access to health in low and middle income countries, he said.
On Ebola, some industry representatives, such as Pender of GlaxoSmithKline, indicated that the WHO had not provided sufficient leadership on the issue, as industry responded vigorously once it got the message. Oschmann said there “cannot be a blame game” over what happened but rather working together.
Outgoing IFPMA President John Lechleiter stressed among his points that the Ebola epidemic “is a poignant reminder of the need to sustain innovation to address the many unmet – and unanticipated – health needs around the world.” In particular, he added, “we must encourage innovation for neglected diseases. This should remain firmly on our agenda.” Industry stands ready to contribute to the Ebola crisis “with knowledge and expertise.”
Another speaker said the debate over innovation versus access is really about “false choices,” as they are actually synergistic. Pharma is trying to deal with the access issue, such as through tiered pricing. Industry and those seeking access both recognise that innovation and access must both exist.
The speaker also said that coming off the Ebola crisis, industry is going to have to assess where it can and cannot challenge its assumptions. If it doesn’t take this as a lesson to ask where it can accelerate things, cut costs, use technology, then they are going to be the ones left behind.
Source: Intellectual Property Watch