The U.K. introduced stronger regulations Monday, Feb. 10 to better protect against a coronavirus outbreak. Effective immediately, the new regulations will ensure that individuals suspected of having 2019-nCoV are kept in isolation for 14 days, according to U.K. Health Secretary Matt Hancock. As of Monday, 1,114 people in the U.K. had been tested for the virus, eight of whom tested positive. Based on the World Health Organization’s Jan. 30 declaration that the new coronavirus is a public health emergency of international concern, the U.K. raised the risk to the public from low to moderate, Chief Medical Officer Chris Whitty said. Although the risk to individuals in the U.K. remains low, the elevated risk level permits the government to prepare proactively, he said.
If the Feb. 10 opinion of the U.S. Court of Appeals for the Federal Circuit stands in Acetris Health LLC v. United States, companies that source active pharmaceutical ingredients (APIs) from India for drugs that they manufacture in the U.S. will be able to bid for Department of Veterans Affairs (VA) and other federal contracts. Under the Trade Agreements Act (TAA), the VA is prohibited from purchasing products of certain countries, including India. In addition, the Federal Acquisition Regulation (FAR) directs agencies to purchase “U.S.-made end products” before products from certain foreign countries. In the past, the VA followed Customs and Border Protection’s (CBP) long-held determination that the source of a drug’s API dictated its country of origin, so it refused to award contracts for drugs that were manufactured in the U.S. from APIs made in India and other countries barred under the TAA. Citing the CBP interpretation, the VA barred Allendale, N.J.-based Acetris’ drugs that are manufactured by Aurolife Pharma LLC in Dayton, N.J., using API from India. The CBP’s interpretation is wrong, the appellate court said. “The regulatory history of the term ‘U.S.-made end product’ makes clear that the source of the components (here, the API) is irrelevant in determining where a product is ‘manufactured,’” the Federal Circuit said. The court noted that when the government proposed FAR, it explained that the rule “defines U.S.-made end products as products that are manufactured or substantially transformed in the United States, regardless of the source of the components.” Thus, drugs manufactured in the U.S. are not products of the country in which their API was made. “If the government is dissatisfied with how the FAR defines ‘U.S.-made end product,’ it must change the definition, not argue for an untenable construction of the existing definition,” the court said.
As the U.S. Trade Representative prepares its 2020 Special 301 Report, the Pharmaceutical Research and Manufacturers of America (PhRMA) is urging it to defend American biopharma innovators and jobs by ending market access and intellectual property barriers in 24 economies around the world. The PhRMA submission requests action to reverse compulsory licensing in Malaysia and to end damaging pricing policies in several markets, including Canada, Japan and South Korea.
India’s Central Drugs Standard Control Organisation (CDSCO) extended the deadline for manufacturers of fixed-drug combination (FDC) products that were licensed with state authorities before Jan. 10, 2012, to apply for licensure with the Directorate General of Health Services. The original application deadline was Nov. 22, 2019. Manufacturers now have until May 30, 2020, to apply to the Directorate for a license for their FDCs, according to CDSCO.