?Despite widely diverging approaches to public healthcare services, the United States and the European Union still believe the Transatlantic Trade and Investment Partnership (TTIP) will enhance regulatory cooperation, chiefly on medicines approval.
In Europe, universal healthcare is a source of national pride, as well as a constant subject of debate. The inclusion of a healthcare chapter in the ongoing TTIP talks has already triggered heated reactions from health organisations, who are wary of American-influenced liberalisation of a heavily regulated sector.
In the United States, the Food and Drug Administration (FDA) has been slower in approving some new cancer drugs and medical devices than the European Medicines Agency (EMA). TTIP advocates contend that increasing coordination may bring benefits to pharmaceutical companies by reducing compliance costs.
Douglas Gregory, executive director for European Government Affairs at Amgen, an American multinational biopharmaceutical firm, stressed healthcare had to be distinguished from other sectors.
“In other sectors, we are looking at mutual recognision of end-products, so that a product approved in the US can be sold in Europe and vice versa,” Gregory said.
“In healthcare, we are talking about how we can build closer collaboration between our regulatory authorities,” he told a panel debate organised on Thursday (19 March) by the American Chamber of Commerce in Europe.
Sébastien Goux, the EU’s TTIP lead negotiator on pharmaceuticals, said intensifying exchange of information was the main focus of the talks. At the moment, the EU and the US are negotiating how to exchange confidential information regarding regulatory inspections. Afterwards, the authorities will debate how to exchange other types of information, such as clinical trials for pharmaceutical products.
Another objective is to enhance cooperation on the authorisation of biosimilars, biological products, and on generic drugs, Goux said. For example when it comes to biosimilars, the US has been paving the way for the authorisation of such products at a much faster speed than in Europe.
Donald Prater, the acting director of the Europe Office of the US Food and Drug Administration (FDA), highlighted the importance of having regulators at the negotiating table.
“We bring valuable perspective to ensure the high standards are maintained. Our talks are often very technical and require scientists, policy advisors, legal analysis and in many cases, these issues are some we have discussed for some time. But the difference with TTIP is that it gives us the emphasis to devote resources to actually try to tackle these issues,” he said.
According to Prater, there will be benefits to pursuing enhanced regulatory understanding on both sides.
“I think ultimately, some of the benefits will be that we can better concentrate our resources to provide oversight of medical products. If we can rely on other regulatory counterparts then it helps us to better use our resources across the world. There are benefits for the US and the EU, and particularly for consumers. We are putting the resources where they are going to have the most impact.”
What will be important for the healthcare and pharmaceuticals discussions in TTIP will be the societal challenge for the sustainability of healthcare systems, said Adrian van den Hoven, the director general of the European Generic and Biosimilar Medicines Association (EGA).
“One of the key challenges for the regulators … will be how they are going to regulate so that we get higher standards of medicines, while at the same time ensuring that societies can afford these medicines. Public payers will be paying for that both in the US and in the EU. This is a real challenge for the regulators,” van den Hoven said.
Regulatory cooperation between the FDA, the EMA and the Commission can lower regulatory costs while maintaining high standards, van den Hoven claimed, for example on clinical trials.
“Any medicine in Europe or in the US has to be approved through some form of clinical trial. With biosimilar medicine, they have already achieved that you can now legally do a clinical trial for both jurisdictions. That doesn’t mean that there won’t be slightly different requirements on both sides sometimes, but at least the legal possibility to do this is out there and this is significant because a large clinical trial can cost between $50-100 million dollars (€46-92 million).”
“Right now, we are creating the legal possibilities to just share information with each other and to develop the common approaches to the regulatory principles and where they need to apply. This is a huge step and really significant,” the director general of the EMA stressed.