Minister of Culture Lung Ying-tai’s (龍應台) recent complaints about the transparency requirements for financial declarations again highlights how ignorant government officials are about the necessity to have their own wealth subjected to public monitoring.
Also over the past few days, politicians from both the pan-blue and pan-green camps and even academicians from Academia Sinica have again taken up the old complaint about disputed cases in the biotechnology industry, pointing the finger at each other. This clearly misled the public and deliberately ignored mistakes that have been made when it comes to the necessity of transparent governance and public accountability.
Because cooperation between industry, government and academia in the biotechnology field became more complex and resulted in more and more conflicts of interest between these three groups, US legislation — which large biotechnology companies like to quote, but which in fact is not very clear — began to regulate conflicts of interest in 1995. This legislation became stricter following significant amendments in 2011. In addition to lowering the threshold for declaring conflicts of interest, all benefits derived from the jobs performed by researchers in their organization or from their responsibilities must now be declared, and the 1995 laws that only required that financial interests be declared no longer apply.
Furthermore, these new regulations require that declarations made by research organizations now must be made externally, to the public, instead of internally to the organization to which the leader of a research project belonged.
All researchers involved in federally funded plans were also required to periodically receive training on research ethics, including conflict of interest regulations.
Since 1999, the US Food and Drug Administration (FDA), which regulates the US biotechnology industry, has demanded that pharmaceutical companies and companies specializing in medical instruments disclose the relationships between their clinical researchers and their company, in terms of financial payments and financial interests, when filing an application for introducing a new product on the market. This was done to make it easier for the FDA to evaluate whether these relationships would affect research design or the credibility of the data used.
In addition, in the legislative reforms made to health insurance that US Congress passed in 2010, regulations were introduced about how biotechnology companies must periodically declare to the government the consultation fees, research fees, travel and dining expenses and subsidies paid to doctors and teaching hospitals, as well as the investments and shares they have in every last one of their companies. Furthermore, this information has to be released publicly.
Simply put, regulations regarding conflicts of interest in the US biotechnology industry are becoming increasingly strict, unlike what certain people in the industry here like to say to support their arguments for relaxing legal regulations.
US regulations have changed from specifying only that such information be disclosed internally to a researcher’s own organization or department toward a system in which both researchers and biotechnology companies must make declarations, and both have to disclose such information to the public. This was done with the goal of allowing the public to compare information, thus encouraging more transparent practices and making it easier to hold researchers and pharmaceutical companies to account.
The regulations of Article 6 of the Act on Human Subjects Research (人體研究法), passed in 2011, demand that research proposals clearly list any conflicts of interest that a researcher may encounter. The same year, Article 6 of the Basic Act of Science and Technology (科學技術基本法) was amended and it now states that the Cabinet will arrange and prescribe all relevant procedures for reclamation of intellectual property rights or results derived from technological research projects funded by the government. In addition, Article 79-1 of the Medical Care Act (醫療法) also has similar regulations on recusal resulting from conflicts of interest and the disclosure of information.
However, while some initial regulations have been made for conflicts of interest between scientific research organizations and their staff, both the pan-blue and pan-green camps have yet to show any responsibility for constructing a list of items to be regulated, for example, the scope of disclosure of benefits and concrete numbers and content, as well as the review and error correction mechanisms used after declarations are made.
Also, we have yet to see anyone pay attention to the very serious and increasingly common problem of people who used to be government officials getting involved in industries and the serious conflicts of interest that this causes.
Let us consider this for a moment. Given that even researchers and manufacturers are subject to relatively strict rules regarding conflicts of interest so that they can be held accountable by the public, why are things still going so slowly with the demands made of government officials, who are supposed to be responsible for carrying out government policy, to make any information about conflicts of interest available to the public?
Furthermore, when things get stuck in useless arguments over whether certain practices run counter to current laws, they easily turn into tools for political battles.
With such unhealthy developments, how can people not be expected to question the capability of Taiwan’s biotechnology sector to achieve sustainable development?
Liu Ching-yi is a professor in National Taiwan University’s College of Social Sciences and head of the Taipei Society.
Translated by Drew Cameron
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