The proposed updated European Union General Pharmaceutical Legislation offers some opportunities but also creates some new threats for biotech—and when it becomes law in a couple of years, it will bring dramatic changes for the industry, according to panelists at a Nov. 6 session at BIO-Europe in Munich.
“We’re in the middle of the largest change in the pharmaceutical landscape for 20 years. It’s going to change how you do business,” said Dr. Claire Skentelbery, Director General of EuropaBio. “Europe’s current biotechnology and healthcare landscape is really shaped by the legislation in which it sits, particularly in areas such as rare diseases, but across the whole landscape for biotechnology innovations.”
Some potentially harmful impacts of specific provisions were outlined in Dr. Skentelbery’s fireside chat with Daniel Steiners, General Manager of Pharmaceutical Business in Germany for Bayer. It was one of many in-depth panels taking place at the Nov. 6-8 BIO-Europe, Europe’s premier partnering event for biotech, sponsored by the Biotechnology Innovation Organization (BIO) and EBD Group.
A goal of increased patient access
Dr. Skentelbery said reform of Europe’s pharma law is necessary, and the proposal is founded on sound principles.
“The time was right. All legislations age and the ambition behind the new legislation that has been proposed is a very noble one: It is to enable more patients to gain access to medicines across Europe at a cost that can be shouldered by the many countries in Europe,” she said.
Indeed, in another panel at BIO-Europe on cell and gene therapy, participants expressed the hope that updates to EU legislation would permit greater legal acceptance of genetically modified organisms, which are tightly controlled in Europe.
An earlier analysis of the new law by experts at BIO noted that some parts of the proposed EU Pharma Law would be helpful for the biotech industry. But BIO’s experts also expressed concerns about provisions in the law that would discourage biotech innovation, and so did Dr. Skentelbery.
“The devil is always in the detail, and the road to hell is paved with good intention,” she said at BIO-Europe.
Reduced period of IP protection
One provision in the new law would reduce the data protection for patents of new drugs—the time before competitors can start developing generic versions—from the current eight years to six years. But, as part of the effort to encourage greater patient access, the law would increase data protection back to eight years for drugs that receive approval in all 27 EU countries.
While he said he admired the idea of promoting broader access to drugs, Steiners said the remedy proposed by the new legislation unfairly punishes drug makers.
“It’s not that we as companies don’t want to commit to filing for approval. But getting the approval is not within our control. So it can be that we file in 27 Member States for approval but still do not get the approval in those states because this is nothing we control. So we would lose two years of patent protection,” he said. “Now, if you do the business case for any drug development, I think all of us here know that losing two years in the European market is a huge number.”
Given the risk of losing data protection earlier, drug developers will likely focus on selling their products in the United States or Asia. In effect, the stipulation aimed at greater patient access to drugs might result in drugs not being available anywhere in the EU, Steiners said.
Narrow definition of drugs for ‘unmet need’
Another means for extending the patent period of a new drug under the proposed law would be to provide a drug defined as meeting an “unmet medical need,” but according to Steiners, the definition is too narrow.
“Unmet medical need is only for life-threatening or severely debilitating diseases. It doesn’t say anything about things like disease burden, quality of life, etc.,” he said. “If you have diabetes and if you suffer from diabetic neuropathic pain, it is not considered a debilitating disease as there are treatments for diabetes. So you just have to suffer.”
To encourage greater development of drugs for chronic pain or other conditions, the concept of unmet need must be expanded, Steiners said.
Biotechs urged to speak up
Some of the changes proposed in the European pharma legislation would push many small, innovative biotechs out of Europe, according to Dr. Skentelbery.
“The impact on these small companies will be that they will simply not exist in n the first place, or they will have to move to the U.S.,” she said.
But Dr. Skentelbery pointed out that there needs to be more negotiation and change before the law is finalized, over the next few years. She urged small companies to speak up now and ensure that lawmakers in Europe understand the reality of the business.
“I think it helps to bring your stories up to your national policymakers and the European policymakers,” she said. “We can give them more practical examples of what happens to small companies.”
