Post-EU FMD deadline - 'business as usual'?

12 Feb 2019

Partner connectivity will be an immediate and ongoing challenge beyond the deadline and several pharma companies are likely to break agreements with current suppliers through breach of contract clauses.

As the enforcement deadline for the EU’s Falsified Medicines Directive (FMD) passes, Jean-Marie Aulnette, vice president of EMEA sales at TraceLink, discusses the industry’s readiness and what the future holds for serialization.

Post-EU FMD deadline - 'business as usual'?

Industry readiness

"The pharma supply chain is in varying states of readiness regarding compliance with the Directive and we’ve seen a number of patterns emerge over recent months.

"A significant number of contract manufacturers and packers that were initially reliant on their line equipment vendors to deliver partner and regulatory body connectivity have moved to TraceLink during the last 5 months or so. Most realized that their vendor would not make the deadline and could not risk non-compliance - if they were not able to provide serialization, they would have risked losing any contracts they had with pharma companies.

"The cost and complexity of FMD compliance has also led to consolidation among some CMOs that were simply not able to invest in and implement a solution and decided to merge with better-prepared companies as result. There have also been some losses on the pharma side as a number of companies have decided to stop production of RX products because of the cost of regulations and not being able to meet the requirements.

"When it comes to pharma companies, where their incumbent supplier could not deliver a compliant solution in time, many have delayed switching as they do not have the same pressures around losing clients as CMOs and they are under contractual agreements. It is likely that post-deadline, we will see several pharma companies break agreements with current suppliers through breach of contract clauses and switch to other vendors that they know can rapidly deliver a compliant solution. This may take as little as 2 months for some if they have already undertaken steps such as preparing master data and ensuring appropriate teams and documentation are in place."

What’s next?

"Partner connectivity will be an immediate and ongoing challenge beyond the deadline - most organizations established their connection with the European Medicine Verification Organisation (EMVO) first and then began on-boarding partners, prioritizing the more valuable relationships (often decided by revenue, value or volumes). As a result, not all actors in some company’s supply chains are connected. Where these businesses are using TraceLink’s network-tenant solution, these connections should be resolved fairly quickly, but those that are still using a point-to-point approach face a significant wait before being fully connected with all partners.

"Eventually, the industry will move to a state where serialization is ‘business as usual’ and companies will start searching for supply chain efficiencies and opportunities to deliver better services by improving communications with partners and patients. CMOs and serialization vendors specifically will have to deliver additional value and use serialization to create competitive services, otherwise their customers will look elsewhere.

"To date, the collective pharma industry has been very focused on the costs associated with serialization and is yet to see its potential. Ultimately, having all the additional data being created by serialization in data lakes will enable a number of opportunities; for example, the digital transformation of recalls to derive crucial business intelligence. Better supply chain visibility and providing more information to patients are just the first steps – within the next 2-3 years we’ll see truly revolutionary technology such as Artificial Intelligence being used to deliver predictive analytics for supply and demand forecasting."

Read More

Related news

Eisai collaborates with University of Dundee on cancer drug discovery

Eisai collaborates with University of Dundee on cancer drug discovery

10 Jul 2019

It is hoped that research into PROTACs will lead to new drug discoveries for proteins present in cancer, which are difficult to treat with conventional small molecule inhibitors.

Read more 
Onyx Scientific makes strategic investment in commercial API licence

Onyx Scientific makes strategic investment in commercial API licence

10 Jul 2019

Investment fills the growing gap in the market for manufacturers that have the niche capabilities to deliver small-scale commercial API projects.

Read more 
I Holland to share the science behind tool maintenance

I Holland to share the science behind tool maintenance

9 Jul 2019

Proper maintenance - rather than replacement - of compression tooling will improve profitability.

Read more 
Catalent extends global commercial spray drying capabilities in Europe

Catalent extends global commercial spray drying capabilities in Europe

9 Jul 2019

Company's customers to have immediate access to Niro PSD2 and PSD4 spray driers, which are supported by dedicated clean area facilities for both solvent and aqueous processing of potent or non-potent drug formulations.

Read more 
Operations commence at Wasdell Group’s EU headquarters

Operations commence at Wasdell Group’s EU headquarters

8 Jul 2019

The new facility houses 11 bespoke production suites and temperature controlled high-way warehouses increases Wasdell’s capacity in clinical and commercial packaging, distribution & logistics and QP services.

Read more 
Porvair Sciences launches first Drosophila ChIP kits

Porvair Sciences launches first Drosophila ChIP kits

4 Jul 2019

Offers a single optimised Chromatrap kit with unique buffers and components for Drosophila chromatin extraction and ChIP.

Read more 
Boehringer Ingelheim expands NASH R&D pipeline with new first-in-class compound

Boehringer Ingelheim expands NASH R&D pipeline with new first-in-class compound

3 Jul 2019

Yuhan Corporation to receive up to USD 870 million in upfront and success-based development and commercialization milestones, excluding royalties.

Read more 
Fresh data on protein interactions in Alzheimer’s disease

Fresh data on protein interactions in Alzheimer’s disease

2 Jul 2019

Demonstrates the unique ability of diffusional sizing to assess protein binding in-solution and for difficult-to-study systems.

Read more 
Fujifilm Irvine Scientific to open new cell culture media manufacturing site in Europe

Fujifilm Irvine Scientific to open new cell culture media manufacturing site in Europe

2 Jul 2019

The space will support cGMP manufacturing of animal component-free, dry powder media, liquid media, and downstream bioprocessing liquids.

Read more 
Novartis bolsters ophthalmic portfolio with acquisition of Xiidra

Novartis bolsters ophthalmic portfolio with acquisition of Xiidra

1 Jul 2019

Xiidra 5% is the first and only prescription treatment approved to treat both signs and symptoms of dry eye by inhibiting inflammation caused by the disease.

Read more