The Therapeutic Goods Administration (TGA) has admitted that it has not tested any imported medicinal cannabis products for quality and safety since new rules came into effect in February 2023. The new rules require all imported products to comply with the Good Manufacturing Practice (GMP) standards, which are designed to ensure consistent and high-quality products for patients. However, the TGA has not verified the GMP status of any of the products that have entered the country since then, raising concerns about the potential risks for consumers.
MCIA calls for urgent meeting with TGA
The Medicinal Cannabis Industry Australia (MCIA), the peak body representing the local industry, has expressed its frustration and disappointment with the TGA’s lack of oversight and enforcement of the new rules. The MCIA has called for an urgent meeting with the TGA to discuss the situation and seek clarification on the regulatory framework and expectations for imported products.
The MCIA’s chief executive officer, Peter Crock, said that the TGA’s admission was “shocking” and “unacceptable”. He said that the local industry had invested heavily in complying with the GMP standards, which are among the most stringent in the world, and that it was unfair and unsafe for imported products to bypass the same requirements.
“We have been working closely with the TGA to ensure that our products meet the highest standards of quality and safety, and we expect the same level of scrutiny and accountability for imported products,” Crock said. “The TGA’s admission that they have not tested any imported products since the new rules came into force is shocking and unacceptable. It undermines the credibility and integrity of the regulatory system and puts patients at risk.”
Crock said that the MCIA had requested an urgent meeting with the TGA to address the issue and seek assurance that the new rules would be enforced and monitored effectively. He said that the MCIA was also concerned about the lack of transparency and communication from the TGA regarding the status and availability of imported products.
“We have been asking the TGA for months to provide us with information on the number and origin of imported products, the GMP status of the manufacturers, and the testing results of the products. We have received no response or data from the TGA, despite repeated requests. This is unacceptable and frustrating for the local industry and the patients who rely on our products,” Crock said.
Patients and doctors left in the dark
The TGA’s admission has also raised alarm among patients and doctors who use and prescribe medicinal cannabis products. Many patients have reported difficulties in accessing their prescribed products, as some local suppliers have faced shortages and delays due to the increased demand and the impact of the COVID-19 pandemic. Some patients have resorted to importing products from overseas, without knowing the quality and safety of the products they are receiving.
Dr. David Caldicott, an emergency physician and a clinical lead at the Australian National University’s Australian Medicinal Cannabis Observatory, said that the TGA’s lack of testing and verification of imported products was “astonishing” and “irresponsible”. He said that patients and doctors had a right to know the quality and safety of the products they were using and prescribing, and that the TGA had failed in its duty of care and protection.
“It is astonishing that the TGA has not tested any imported products since the new rules came into effect. This is a serious breach of trust and responsibility. Patients and doctors have a right to know what they are putting into their bodies, and the TGA has a duty to ensure that the products are safe and effective,” Caldicott said.
Caldicott said that the lack of testing and verification of imported products could expose patients to potential harm and adverse effects, such as contamination, inconsistency, and inaccurate labelling. He said that patients and doctors needed reliable and accurate information on the products they were using and prescribing, and that the TGA needed to provide that information as soon as possible.
“The TGA needs to test and verify all imported products as a matter of urgency, and provide the results and data to the public and the medical community. They also need to communicate clearly and transparently about the availability and status of imported products, and the reasons for any delays or shortages. Patients and doctors deserve to have confidence and trust in the products they are using and prescribing, and the TGA needs to restore that confidence and trust,” Caldicott said.
TGA promises to improve testing and communication
The TGA has acknowledged the concerns raised by the MCIA, patients, and doctors, and has promised to improve its testing and communication processes for imported products. The TGA said that it had faced some challenges and delays in testing and verifying imported products due to the COVID-19 pandemic, the transition to the new rules, and the limited availability of accredited laboratories. The TGA said that it was working to overcome these challenges and to expedite the testing and verification of imported products.
The TGA’s deputy secretary, John Skerritt, said that the TGA was committed to ensuring the quality and safety of all medicinal cannabis products, whether they were imported or locally produced. He said that the TGA was in the process of testing and verifying the GMP status of all imported products that had entered the country since February 2023, and that the results would be published on the TGA’s website. He said that the TGA was also working to improve its communication and transparency with the industry, the medical community, and the public, and to provide regular updates on the status and availability of imported products.
“We apologise for any inconvenience and concern caused by our lack of testing and communication of imported products. We are working hard to rectify the situation and to ensure that all imported products meet the same high standards of quality and safety as locally produced products. We are also working to improve our communication and transparency with all stakeholders, and to provide timely and accurate information on the status and availability of imported products. We appreciate the patience and cooperation of the industry, the medical community, and the public, and we are committed to ensuring the best outcomes for patients who use medicinal cannabis products,” Skerritt said.
