Trends, challenges and priorities
To ensure patient safety, the biopharmaceutical industry is heavily regulated, but some regulations can slow the delivery of medicines to the very people they are designed to help.
With the development of new therapy types, as well as the desire to ship medicine directly to the patient, in certain situations this has become a real issue for the industry.
Combine this with the lack of global harmonization, and it can be a difficult environment to navigate.
It’s not just what we traditionally think of as regulations either. The environment is impacted by more than just the expectations of the EMEA, FDA, MHRA, and other bodies.
No-one wants to risk the quality of the supply or impact the patient, however, with the giant leaps in technology some of the regulatory requirements now need to evolve.
Clearly, the challenges posed by raising a deviation for every temperature excursion during shipping remain, despite having a wealth of data to support brief excursions outside the labelled conditions. The biopharma industry in fact, the wider pharmaceutical industry, would like to see a change in this area.
Customs’ expectations for instance don’t consider the needs of a time critical, temperature sensitive, bespoke medicine made in a batch size of one. There is an expectation that customs can hold and even open shipments as they pass through a border. It makes sense to be able to randomly check what is being shipped into your country, especially if the paperwork isn’t comprehensible, but for individualized medicines this poses a big risk. Given that customs’ expectations in terms of paperwork are often not clear, there is an increase in the potential risk of a shipment being stopped. Any delay can result in the medicine no longer being fit for use, impacting on the patient who then has their treatment paused while a new batch is made for them. This risk needs to be addressed.
When we talk about shipping directly to patients, many additional regulations come into play: GDPR, and pharmacy regulations which require the medicine to have been dispensed by a pharmacist in the country (or a particular State in the US) are just two. The biopharma industry faces countless challenges as it seeks to develop new modalities of drug and put the patient at the heart of its supply chains.
This landscape is why BioPhorum has brought together a group of industry experts, to map out the current challenges and create a comprehensive picture of the regulatory landscape as it impacts on the effective distribution of medicines. This group will also recommend where and how changes must be made to truly prioritize the patient’s needs. If you want to get involved contact Phorum Director Lesley Holt at lesley.holt@biophorum