In Serbia, they are expanding their business with a Chinese institute under investigation in the EU and ‘blacklisted’ in the US

The authorities in Serbia have decided to increase their cooperation with the Beijing Genetic Research Institute (BGI) despite ongoing investigations against the institute in several countries.

Cooperation in the fields of scientific and technological research, biomedicine and biotechnology – this is how the Serbian authorities define their relationship with BGI following a recent meeting with BGI representatives.

According to a communiqué of the Government of Serbia, the guests from China expressed their willingness to actively cooperate with their Serbian partners and the Government of Serbia in promoting for the benefit of Serbian citizens and the development of biosciences in Serbia.

BGI is part of the wider BGI Group. It is sanctioned by the United States of America (USA).

According to its website, its main activities are clinical research in human health, the development and invention of new medicines, and scientific research on plants, animals and micro-organisms.

However, the collaboration with BGI has led to investigations in several countries over the alleged misuse of genetic data from prenatal tests, which are used during pregnancy to determine whether a foetus has a genetic disorder such as Down’s syndrome.

As confirmed to Radio Free Europe (RFE/RL), the case was investigated by the competent authorities of three European Union (EU) countries – Slovenia, Germany and Estonia.

They also provided RFE/RL with information on the results of the investigations.

In these countries, prenatal tests produced by China’s BGI are used.

During the testing, samples containing sensitive genetic information are taken.

Where did the investigation start?

Reuters reported in a text published in July 2021 that China’s BGI, which sells non-invasive prenatal tests worldwide, developed the tests in collaboration with the country’s military.

The Reuters article referred to reviews of scientific papers and interviews with researchers who have worked with BGI.

BGI has denied Reuters’ allegations of misuse of DNA data through prenatal testing and collaboration with the Chinese military.

However, three EU Member States, Slovenia, Germany and Estonia, where BGI’s prenatal test technology was sold and used, launched an investigation in 2021, according to Reuters.

As confirmed to RFE/RL by the Slovenian Information Commissioner’s Office, which is also responsible for the protection of personal data, an investigation is underway against the Slovenian company genEplanet d.o.o., which cooperates with BGI and uses their prenatal tests.

The investigation is being carried out, according to the RFE/RL written reply, “on suspicion of processing data without a proper legal basis and providing inadequate (insufficient and misleading) information to individuals about the processing of their genetic data” from prenatal tests. .

The Slovenian Information Commissioner’s Office said that as the investigation was still ongoing, they could not provide further details.

Results of an investigation in Estonia

In Estonia, a domestic company was investigated in 2021 and sent its tests to a laboratory using BGI technology.

This was confirmed by the Estonian Data Protection Inspectorate in a written reply to an RFE/RL query. They stated that during the investigation the domestic company “explained the situation in detail” and the rules according to which the tests are sent to the laboratories.

“The company has corrected other deficiencies in its privacy policy and confirmed that the data related to the tests are stored in the European Economic Area. As a result, we have suspended our supervision of the company,” the Estonian Data Protection Inspectorate said.

Case in Germany

In response to RFE’s enquiry, the German regulator at federal level stated that it did not carry out an investigation and that the data protection authority of the state of Hesse (Hessen) was competent in this case, as the company producing the BGI prenatal is based in the state.

However, as indicated by the German Federal Data Protection Authority, the case was included in their annual report for 2021.

In this report, they state, among other things, that the Data Protection Officer in Hessen checked whether the German company producing the prenatal tests complied with the legal data protection procedures.

They add that it has been agreed with the company in Hessen that samples received for testing will not be sent to BGI’s Hong Kong-based laboratory until this process is completed.

At the time of publication, no reply had been received from the Data Protection Officer in Hessen to the RFE/RL’s questions on the findings of the investigation.

BGI under Pentagon sanctions

On 5 October, the US Department of Defence placed BGI on a “blacklist” for being a civilian company working with the Chinese military.

US companies and individuals are prohibited from investing money in the company by buying or selling securities – stocks and otherwise.

In a statement the same day, BGI denied any links with the Chinese military.

“BGI confirms that it is not owned, controlled or associated with the Chinese military,” read, among other things, BGI’s statement on 28 October.

Since July 2020, two BGI subsidiaries have been blacklisted by the United States (US) for human rights violations against China’s Uighur Muslim minority community.

These companies are Xinjiang Silk Road BGI and Beijing Liuhe BGI.

As the US Department of Commerce stated at the time, they were blacklisted for helping to carry out ‘genetic analysis to further the oppression’ of Uighurs and members of other Muslim minorities in China.

According to the Washington Post, BGI, as the parent company of the two subsidiaries, has denied that it is involved in “the collection, storage or analysis of personal genetic information with the intent to violate the human rights of specific regions or groups.”

BGI in Serbia

BGI’s prenatal tests are part of the production line of the Centre for Genome Sequencing and Bioinformatics in Belgrade.

The centre was opened in December 2021 in a collaboration between the Chinese institute and the Institute of Molecular Genetics and Genetic Engineering of Serbia.

The Centre itself belongs to the Institute of Molecular Genetics and Genetic Engineering of Serbia, which is state-owned.

Genome sequencing, which is its main activity, is a method for reading genetic information, i.e. the hereditary material found in the cells of all living organisms.

In addition to the Genome Sequencing Centre, BGI is also present in Serbia with two Covid-19 testing laboratories, Fire Eye in Belgrade and Niš, for which it has also donated funding.

On 26 November, the Serbian Prime Minister, Ana Brnabić, met BGI representatives in Belgrade.

In a press release, it was announced that the construction of the BIO4 campus in Serbia will start next year.

This campus is planned to be built in Belgrade and would include educational and scientific research institutions, mainly in the fields of biomedicine and biotechnology, in one area.

Cooperation with BGI on this project has also been announced.

According to Brnabić, “the transfer of experience and knowledge and cooperation with one of the most important companies in the world in these fields is of great importance for Serbia”.

BGI: “We don’t have access to data in Serbia”

The BGI Group, under which BGI operates, claims that it does not have access to the data processed at the Genomic Sequencing Centre in Belgrade.

“BGI Group will provide the technology and know-how, but will not have access to the data,” the Chinese company said in a written response to an RFE/RL query.

They also stated that there is no agreement between BGI Group and the Belgrade Centre to share genetic data obtained in the context of testing and sample processing.

When asked how they commented on the fact that investigations are being or have been carried out in several countries regarding the possible misuse of genetic data, BGI Group replied:

“BGI Group meets strict standards in the area of information security, including compliance with the General Data Protection Regulation (GDPR).”

The GDPR is the European Union’s (EU) General Data Protection Regulation, which came into force in May 2018.

The regulation ensures that personal data is not misused and that access to this data by other persons, companies and institutions is limited only to the extent necessary.

In November 2018, in order to comply with European legislation, given that Serbia is seeking EU membership, Serbia adopted the Law on Personal Data Protection, which regulates, among other things, who can access personal data and how processed, how much and how it is stored.

The law in Serbia complies with the personal data protection standards applicable in the EU.

What is genetic data?

Genetic data – personal data relating to inherited or acquired genetic characteristics that provide unique information about a person’s physiology or health. It refers in particular to those data obtained by analysing a sample of biological origin (containing DNA).

Under the current law in Serbia, the processing of genetic data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs or trade union membership, as well as the processing of genetic and biometric data for the purpose of uniquely identifying a person, information on a person’s state of health or information on a person’s sex life or sexual orientation is prohibited.

Serbian government: ‘All data remains in our country’

In response to an RFE/RL query, the Government of Serbia claims that all information and biological material obtained or processed at the Centre for Genome Sequencing and Bioinformatics remains in Serbia.

“All data generated at the Centre for Genome Sequencing and Bioinformatics, including the results of prenatal screening, will be stored exclusively at the National Data Centre in Kragujevac,” the government told the RFE/RL.

The Institute of Molecular Genetics, which established the Genome Sequencing Centre in cooperation with the Chinese BGI, “operates according to the highest ethical and legal standards, including the harmonisation and application of the law on the protection of personal data”, the statement added.

The Serbian government did not reply to a question on whether it was aware of investigations underway in, among others, three EU Member States into the possible misuse of genetic data by the Chinese institute.

Without a request to the Data Protection Officer to transfer data to other countries

The Office of the Data Protection Commissioner told RFE/RL that it has not yet been contacted by the Centre for Genome Sequencing and the Institute for Molecular Genetics and Genetic Engineering about the transfer of personal data to other countries and international organisations. .

The Data Protection Officer is an independent body accountable to the Parliament of Serbia.

If an institution wishes to transfer personal data of Serbian citizens to one of the countries where the Government of Serbia has not assessed that the data would be secure, it must seek the permission of the Commissioner.

This procedure is part of the Law on the Protection of Personal Data.

The Government of Serbia has on its website a list of 54 countries with a so-called adequate level of protection of personal data. China is not on the list.

The Commissioner’s Office informed that the text of a draft law on the central register of genetic biomedical and other data relevant for research and development in the fields of biotechnology, bioinformatics, bioeconomy, genetics and medicine is being drafted./RSE/