On 21st November 2013, the Medicine and Healthcare Products Regulation Agency (MHRA) announced the decision to stop the “sell through” of herbal medicine products from the 1st May 2014. Following the announcement, ATCM took legal action against the decision made by MHRA. Below a chronicle of events is presented to show all the details of the legal case.
- In July 2013, MHRA initiated the public consultation on the proposal to stop the “sell through” of herbal medicine products. In the proposal, MHRA suggested to stop the “sell through” at the end of 2013. This was about 3 years after the implementation of the European Directive 2004 in May 2011.
- In August 2013, ATCM carried out a survey to investigate the impact of the MHRA decision on members’ business.
- ATCM council consulted with lawyer to explore the possibilities to protect members’ interests by taking legal action.
- On 3rd September 2013, ATCM submitted its response to MHRA’s consultation requesting to extend the deadline of stopping the “sell through” to the end of 2015. This was based on the general shelf-life of TCM patent herbal medicine products , which are 4-5 years.
- On the 21st November 2013, MHRA announced the decision in its press release to stop the “sell through” from the date of 1st May 2014.
- ATCM council decided to take legal action to challenge the MHRA’s decision. On 16 January 2014, ATCM president Dr. Kaicun Zhao discussed the case with the lawyer and gave formal instruction to the lawyer to start the process of legal action.
- On 3rd February 2014, Dr. Zhao had a further discussion on the case with the counsel.
- On 19 February 2014, the lawyer submitted the “Witness Statement” made by Dr. Kaicun Zhao on behalf of ATCM to the High Court to apply for a judicial review on the MHRA’s decision. In the statement our main claims were:
- MHRA’s decision did not consider the fact that the shelf-life of most of the TCM herbal medicine products (concentrated pills) is 4-5 year. As independent evidence, officially published shelf-life of TCM patent medicines by Tong Ren tang was provided. The decision was conflictive to the guidance given by MHRA in August 2010 which clearly stated that practitioners can sell through their stock of TCM patent medicine as long as the herbal medicine products were purchased before the date of 1st May 2011 when the EU Directive is implemented. According to the guidance and taking the shelf-life into account, the deadline to stop the “sell through” should be the end of 2014 or 2015.
- The 2010 guidance provided by MHRA gave misleading information causing practitioners over stock their herbal medicine products.
On 18 March 2014, MHRA submitted its responses to the court and rejected ATCM’s claims. Its main points include:
- The 2010 guidance did not provide misleading information to practitioners.
- MHRA’s decision was based on the general shelf-life (3 years) of herbal medicine products.
- MHRA did not accept the evidence of shelf-life of TCM herbal medicine products provided by ATCM as independent evidence.
On the 1st April 2014, Dr. Zhao replied to the MHRA’s defending responses and made strong augments:
- The MHRA guidance in the August 2011 did promise to allow retailers to sell through of their stocks of herbal medicine products as long as the products were purchased before the EU Directive 2004 was implemented.
- The evidence provided for shelf-life of Chinese herbal medicine products was from the official website of a prestigious manufacturer. It is published on the website. This is independent evidence.
- MHRA’s decision was based on the general shelf-life of Western herbal medicine products most of which are tinctures or capsules. These are very different in shelf-life from the TCM products which are a concentrated pills or traditional honey pills.
After careful consideration, ATCM council decided NOT to pursue the case any further at the end of April 2014. This decision was based on the following reasons:
- The argument can be wrangling for a long time.
- The evidence which supports the shelf-life of the major form of Chinese herbal medicine products (concentrated pills) is for 4 years. This means that the medicines held by our members will be mostly expired at the end of 2014, but the case even then may be still long way to go to get a clear outcome.
- The cost will be likely much higher than we can afford comfortably.
Although the case was not able to proceed further due to financial difficulties, ATCM council has done its best to try to protect its members’ interests. The legal action also helped the publicity of ATCM.