The federal government has admitted that the conditions for the production of important drugs for Germany in Asian countries are sometimes very problematic. The government is “aware that in the People’s Republic of China and India, residues from pharmaceutical production, especially antibiotics, enter wastewater, groundwater and drinking water along with wastewater,” she answered a small question from a left-wing parliamentary group in the Bundestag. which is available for Tagesspiegel Background Health & E-Health. Nor can it be ruled out that the population in the vicinity of pharmaceutical production plants is at risk due to insufficiently filtered discharges of waste water from pharmaceutical plants contaminated with pharmaceutical residues’.
State Secretary for Health Thomas Gebhart mentioned regular quality monitoring through on-site inspections, which are “an essential prerequisite for the import of medicines from third countries”. However, environmental aspects are not covered by EU “good manufacturing practice” (GMP) rules. It is the responsibility of the relevant local authorities to check that the relevant environmental regulations are observed during the manufacture of the medicinal products.
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Fear of resistance
Sylvia Gabelmann, a spokeswoman for drug policy in the left-wing parliamentary group, accused the federal government of failing to adhere to social and environmental standards in drug-producing countries. Violations of GMP regulations and environmental requirements are on the rise, but there is “no reason for the federal government to act,” Tagesspiegel said. “I don’t find it bearable.” The last Indo-German government consultations in November 2019 did not address the issue, as the government confirmed.
In fact, experts are increasingly concerned about the production conditions of important drugs in countries such as China, India and Pakistan, especially given the threat of antibiotic resistance. This also includes the president of the German Medical Association, Klaus Reinhardt. In countries like India, drug production takes place under “sometimes scandalous conditions,” the medical president said recently in an interview with Tagesspiegel. “There are areas around the plants that are completely contaminated with multi-resistant bacteria that we can’t do anything about.” At some point, they also come to us through passengers. “And that, according to Reinhardt,” could then pose much bigger problems than coronavirus. “
Lowest level of controls, high level of invocation
When asked about the number of on-site tests, the federal government only refers to the federal states’ annual drug monitoring reports. Probably so that you don’t have to report the sad result yourself: These reports show that the number of inspections from third countries has been steadily declining since 2014, reaching an all-time low in the last reported year 2018. During these five years, it has fallen from 264 to just 177 inspections per year. There were 27 active substances, slightly more than 15 percent. The number of recalls in the last examined year 2018 also reached a new record 188. In the previous year there were only 127, in 2016 only 105.
Then there is the corona crisis, which makes everything worse. “Since the start of the Covid-19 pandemic, inspections have been severely restricted,” the state secretary admitted. In this respect, it is currently not possible to assess the effects of the new law on greater security of supply of medicines on the testing behavior of supervisory authorities. In German: Controls have been further reduced due to the pandemic and details are unknown. Specifically, the law was passed in the summer of 2019 to allow further and tighter controls by German and European supervisors – including in response to scandals surrounding Brandenburg Lunapharm, an importer of cancer drugs and contamination of the widely used antihypertensive valsartan by a Chinese supplier.
Only registered controls
In addition, according to the government, inspections in third countries such as India and China must be “registered” – and, as the Secretary of State writes, “for organizational and logistical reasons.” Manufacturers may therefore prepare adequately for the visit of inspectors. However, the federal government had “no evidence that compliance with German and European regulations was not effectively monitored,” Gebhart said.
The Secretary of State even names the complaints by naming them. The federal government is aware, writes that Pakistan’s Resochin tablets from Bayer “are not manufactured in accordance with European requirements of good manufacturing practice (…)”. Resochin is the trade name of Bayer for the active ingredient chloroquine. Due to serious shortcomings in quality at the plant in Karachi, the group stopped production nine months ago. When the drug, which had been developed as early as the 1930s, was now considered a potentially promising therapy against Covid-19, it was re-expanded. Germany also tried to find resources.
There are also many breaches of “good manufacturing practice” in Europe.
In addition to quality deficiencies and environmental problems, critics also complain about conditions that sometimes increase the willingness of workers and test subjects. In 2016, the federal government specifically adopted a National Action Plan (NAP) on “respect for human rights in global supply and value chains” – and also sent a questionnaire to companies on how they deal with suppliers from developing or emerging countries. However, the Secretary of State for Health could not even answer the simple question of how many pharmaceutical companies were contacted and answered. During the monitoring, it was found that the data evaluation and conformity assessment will be presented only “in an aggregated and anonymous form”, he stressed. Therefore, the federal government is not aware of any details. Left-wing politician Sylvia Gabelmann could hardly believe it. If the action plan brings “zero knowledge gain”, it is not worth his name, she said.
“But black sheep are not just in the Far East,” said a left-wing politician. Monitoring bodies at EU level have also reported breaches of the GSP guidelines. According to the federal government’s response, the EudraGMDP European database lists “only 141 GMP non-compliance reports” in the last decade alone.