Together with Robert F. Kennedy JR (RFK JR), the new focus of fiscal conservatism and public health reform is a helper by the Ministry of Health and Welfare (HHS), and promises a significant change in patients, providers and pharmaceutical industries.
Team Trump’s pharmaceutical policy focuses on deregulation and innovation, and the administration plans to shorten the FDA approval process. New drug To reach the market.
This includes exploring the use of artificial intelligence (AI) in clinical trials and approval, which can innovate the drug development process.
Elizabeth Kuiper, Deputy Director of the European Policy Center, told EURACTIV: “The US Federal Pharmacy Pharmacy Review Process is recognized as a gold standard worldwide. FDA decisions are adopted in many countries around the world without regulatory agencies.
“FDA’s resources will be critically reviewed by Doge. The decrease in FDA resources may have influenced the regulatory agency and may have suffered greater failure in the European pharmaceutical agency (EMA). ”
Innovation agenda
Luxury therapies, such as genes and cell processing, are at the forefront of the administration. Innovation agenda.
The administration provides a significant advantage to the sponsor, including the framework established for the first semester of Trump, including the regenerative medicine advanced treatment (RMAT).
It also aims to improve the use of actual evidence and patient -centered data to approve the drug faster, and to closely investigate the misuse of large pharmaceutical companies.
The development of rare disease drugs is not the priority of the administration, but due to continuous support for rapid approval route and special programs, the sector is faced with funding with RFK pivot to focus on preventing chronic diseases and increasing medical transparency.
Regulation
Daniel Matthews, the EY Global Life Sciences leader, added to Euractiv, “If the US takes a new path of public health policy, regulators can develop more and more.
In the long run, Matthews thinks that European pharmaceuticals and medical companies should retake their business and pivot towards other markets and partners.
“For the past three years, we have increased the license activities of European pharmaceutical companies that use China’s biotechnology innovation,” he said. Matthews believes that European companies can build a more powerful connection with Chinese biotechnology as European companies weaken in the US-European life science.
“It can also be potentially lead to European countries that want to rebuild their pharmaceutical industry to pursue local self -sufficiency.”
Price conditions
“The Trump administration is expected to find a way to adjust the price of R & D and some manufacturing as a premium for those with significant positions in the United States. Fredrik Erixon, a Swedish economist, Fredrik Erixon and the European International Political Economic Center (ECIPE), told EURACTIV.
He pointed out that the EU division on R & D -based pharmaceuticals has been greatly reduced to R & D Pharma’s US sector for the past 20 years. Erixon said, “Big Pharma is already assigning much more of R & D portfolio in the United States.”
Regarding the manufacturing industry, Erixon believes that the market is difficult.
“EU producers import a lot of APIs from China and have a supply chain measurement in the United States, and EU pharmaceutical production should have a different source,” he added.
Increasing competition and cost
Focusing on repatriation of pharmaceutical production to the United States and imposing tariffs on pharmaceutical imports can interfere with European pharmaceutical companies’ transactions and increase costs.
This protectionist approach can increase competition from EU pharmaceutical companies and lead to higher costs and potentially affect global competitiveness.
Targets for pharmaceutical imports and the US’s domestic production can lead to an additional supply chain.
Ericsson said, “25 %of tariffs are very important and will reduce bilateral trade to 20-30 %over time, and perhaps reduce product transaction surpluses with the United States.
But ERIXON added that the EU would not be aimed at it, but added that “we will see the world’s trade assignment where most countries deal with the United States more with the United States.”
We support funds for innovative medicines
“Trump does not like the US pharmaceutical prices, but wants to reduce spending.” Erixon said the US administration was frustrated according to the situation, but because he was a major fund for innovative pharmaceuticals, many other wealthy countries thought they were freely in the United States.
“They are not wrong,” he said.
As the EU relies on an integrated supply chain for active pharmaceutical components (APIs) and finished pharmaceuticals, all interruptions can affect the availability and economics of essential medicines in Europe.
The EU needs to strengthen its pharmaceutical manufacturing base to reduce its dependence on external suppliers and ensure strategic autonomy.
Direct drug exports
Matthews observed that in terms of European -based companies, tariffs such as 25% EU tariffs proposed by Trump last week could reach complex biological exports with important beings in Europe.
“Some major market players in Europe have already reduced the US market as part of the US government’s sanctions on Denmark.
Matthews says the version of this scenario can be played in multiple therapeutic areas if the constraints face import tariffs, Matthews says.
He said, “The possibility of mutual tariffs on US imports. The downstream effect of this potential escalation is not clear, but it can include increasing costs in Europe, shortage, supply chain disorder, and increasing instability in health and life science industry. ”
The cause of optimism?
Initiatives, including Critical Medicines Act (CMA), aim to improve local production, improve supply chain resilience, and ensure the possibility of use of important medicines.
This can eventually help the EU to alleviate the impact of the US protection country policy and strengthen strategic autonomy, but the effect of increasing the cost of production due to tariffs will inevitably result in the EU’s drug prices.
But this is especially relevant to general medicines that rely on low API sourcing in countries such as China and India. As a result, the EU may need to take action to control pharmaceutical prices and ensure the economics of the patient.
Nevertheless, Elizabeth Kuiper said, “The pharmaceutical company seems to be more optimistic about what Trump II means the government’s policy on merger and acquisition.”
Route to improve transactions
Matthews thinks the view is less clear. “Other mechanisms, not tariffs, are likely to provide an easier path to improve US transactions. For example, the United States can provide accelerated approval to companies that conduct more clinical trials in the United States, and the US price has been lowered for faster approval. ”
He said, “We will reduce our domestic pharmaceutical investment and potentially reduce the approval time of up to one year.”
Brian Maguire-EURACTIV Advocacy Lab
