WHO committee calls for gene editing tools to be shared with poorer nations

By Ludwig Burger

FRANKFURT (Reuters) -A World Health Organization (WHO) committee said on Monday that human genome editing technologies to treat serious disease should be shared more generously, to allow poorer nations to benefit from the highly dynamic scientific field.

“WHO should work with others to encourage relevant patent holders to help ensure equitable access to human genome editing interventions,” the 18-member committee said in a report, which covered a wide range of governance structures and processes.

The panel of gene editing experts was established in late 2018 after a Chinese scientist said he had edited the genes of twin babies to make then resistant to HIV infection.

Underlining the WHO’s existing stance, the report strongly opposed making modifications to the genetic code in humans that would be passed on to future generations, known as heritable germline genome editing.

“No-one in their right mind should contemplate doing it because the techniques are simply not safe enough or efficient enough and we’re not ready in terms of looking at all the ethical considerations,” said Robin Lovell Badge of Britain’s Francis Crick Institute, a committee member.

But the technology, with the CRISPR/Cas9 ‘genetic scissors’ as its most prominent tool, also holds the promise of curing diseases such as HIV or sickle-cell disease and boosting fundamental medical knowledge, and unequal access could cement global disparities, the panel warned.

“The danger in fully implementing intellectual property as we know it,” would be that rich countries benefit while poor countries bear the main burden of diseases such as sickle cell anemia, Anne Wangari Thairu-Muigai of Kenja’s Jomo Kenyatta University of Agriculture and Technology, told a press briefing.

Intellectual property in medicine became a contested issue when U.S. President Joe Biden in May proposed a temporary waiver of vaccine patents to make anti-COVID-19 shots more quickly available in low-income countries.

Pharmaceutical companies and other countries have argued such a step would be ineffective and risks discouraging work on future health technologies.

Seeking to head off irresponsible human gene modification, the panel also warned it should only be conducted where sufficient policies and oversight are in place, raising the specter of rogue clinics attracting medical tourism to loosely regulated countries with purported therapies or clinical trials.

Specific rules, however, could be a while in the making as WHO said its Science Division would be given up to 3 years to initiate an extensive review of the recommendations, while the review itself could take as long as 18 months.

(Reporting by Ludwig Burger; Editing by Toby Chopra)

Five EU countries say focus should be on vaccine production, not patents

By John Chalmers and Marine Strauss

BRUSSELS (Reuters) -Five European Union countries distanced themselves on Friday from the idea of waiving patent rights on coronavirus vaccines, saying the key to ending the COVID-19 pandemic was making more vaccines quickly.

Leaders of the 27-nation bloc were to discuss the suggestion, backed by U.S. President Joe Biden, at a two-day summit that opened in the Portuguese city of Porto on Friday, but are divided about its usefulness.

Experts say waivers could take years to negotiate, and would not address the immediate need to manufacture more doses fast.

“What is the current issue? It is not really about intellectual property. Can you give intellectual property to laboratories that do not know how to produce and will not produce tomorrow?” French President Emmanuel Macron said on entering the talks.

“The main issue for solidarity is the distribution of doses,” he said, adding that France was working hand in hand with Germany on the issue. Berlin expressed its opposition to the idea on Thursday.

Biden on Wednesday backed a call from India and South Africa to waive patent protection for COVID-19 vaccines, responding to pressure from Democratic lawmakers and more than 100 other countries, but angering pharmaceutical companies.

Some EU officials argue that it could take two years to agree on the waivers in the World Trade Organization (WTO), most likely making it irrelevant to the current pandemic.

DIFFICULT PROCESS

The EU leaders are likely to hear advice from the bloc’s executive, the European Commission, that a waiver would not help to boost production, especially in poorer countries, as the manufacturing process requires advanced technologies and facilities, officials said.

The U.S. firm Moderna waived patent rights in October on its vaccine, which uses using the latest mRNA technology, but no other firm has yet announced that it will try to copy the shot.

Germany, home to BioNTech, which owns a patent on another mRNA vaccine developed jointly with Pfizer of the United States, opposes waivers, while Italy supports them, EU officials said.

While the pandemic rages, the chances are high that even more dangerous new variants of the coronavirus will emerge.

The pharmaceutical industry argues that the most expedient approach is to overcome existing production bottlenecks, and sell or donate vaccines to countries around the world.

“No one we will be safe until we all are. If vaccination takes place only in developed countries, our victory over COVID-19 will only be short-lived. We are seeing how quickly the virus is mutating, creating new variants that entail new challenges,” the leaders of Belgium, Sweden, France, Denmark and Spain said in a joint letter to the Commission.

“Vaccines have become security policy and the EU cannot afford to lag behind; to this end, an increased European production capacity will be a key priority,” they said.

The EU, which is among the biggest producers of vaccines in the world, is also the main exporter, with 200 million doses already shipped outside the bloc. The United States and Britain have not exported any of the vaccines they have made.

(Additional reporting by Jan Strupczewski, Phil Blenkinsop, Francesco Guarasio and Gabriela Baczynska; Writing by Jan Strupczewski; Editing by Kevin Liffey)

U.S. says China has fallen short on ‘Phase 1’ intellectual property commitments

By David Lawder

WASHINGTON (Reuters) -China has fallen short on its commitments to protect American intellectual property in the ‘Phase 1’ U.S.-China trade deal signed last year, the Biden administration’s trade office said on Friday.

The U.S. Trade Representative’s “Special 301” report on intellectual property said that China had made amended its Patent Law, Copyright Law and Criminal Law last year and published several draft regulatory measures on IP.

“However, these steps toward reform require effective implementation and fall short of the full range of fundamental changes needed to improve the IP landscape in China,” USTR said.

The commitments were part of the sweeping deal between former president Donald Trump’s administration and Beijing, which included regulatory changes on agricultural biotechnology and commitments to purchase some $200 billion in U.S. exports over two years.

The USTR report said that there remained uncertainty about the effectiveness of Chinese legal changes, while long-standing problems with trademarks and counterfeiting persist. It also said that Chinese officials have made statements that intellectual property rights should be linked to national security and the need to develop “indigenous” innovation.

“Such statements and measures raise concerns about requiring and pressuring technology transfer and about whether IP protection and enforcement will apply fairly to foreign right holders in China,” USTR said.

China was kept on a “priority watch list” for intellectual property rights enforcement problems, along with Argentina, Chile, India, Indonesia, Russia, Saudi Arabia, Ukraine and Venezuela.

U.S. Trade Representative Katherine Tai told senators earlier this week that her office has not yet scheduled a high-level consultation with China, required twice a year, but would work to hold China to its Phase 1 commitments, including goods purchases.

“We’re continuing to engage with China to make sure that the commitments are implemented,” another USTR official told reporters on Friday.

Asked about a waiver of vaccine intellectual property rights proposed by some World Trade Organization countries, the official said the Biden administration was working with global partners, including WTO members, “to explore pragmatic and effective steps to surge production and equitable distribution of vaccines.”

(Reporting by David Lawder, Editing by William Maclean)

U.S. senators unveil bill to curb foreign espionage, influence on campuses

(Reuters) – A bipartisan group of U.S. senators introduced legislation on Thursday aimed at protecting research and innovation on U.S. campuses and preventing suspected theft of intellectual property by China and other countries.

There is a growing push in Washington to clamp down on spying and intellectual property theft that some Chinese nationals are suspected of engaging in at U.S. universities and colleges.

The “Safeguarding American Innovation Act” proposes to strengthen the U.S. State Department’s authority to deny visas to foreign nationals seeking access to certain sensitive technologies related to U.S. national security and economic security interests.

It also proposes penalizing individuals with fines and imprisonment for failing to disclose foreign support on federal grant applications, as well as lowering the threshold for U.S. schools and universities to report foreign gifts.

“This bill will help us stop foreign governments from stealing our research and innovation while also increasing transparency to ensure that taxpayers know when colleges and universities accept significant foreign funding,” Senator Rob Portman, a Republican and lead sponsor, said in a statement.

The bill, co-sponsored by at least nine Republicans and six Democrats, also aims to give the Department of Education authority to punish U.S. schools that fail to properly report gifts received from foreign entities.

In one of the highest-profile cases to emerge from a crackdown on Chinese influence within universities, a Harvard University professor pleaded not guilty on Tuesday to charges that he lied to authorities about his ties to a China-run recruitment program and funding he received from the Chinese government for research.

Reuters, citing sources, reported last month that the United States is planning to cancel the visas of thousands of Chinese graduate students believed by the Trump administration to have links with China’s military.

(Reporting by Ismail Shakil in Bengaluru; additional reporting by Patricia Zengerle in Washington; Editing by Mark Heinrich and Paul Simao)