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Media And Political Bulletin – 10 August 2018

Media and Political Bulletin

10 August 2018

Media Summary

Falsified Medicines Directive: Six months, six thoughts

Securing Industry, Mark Davison, 9 August 2018

This article highlights the fact that yesterday marked six months until the implementation of the Falsified Medicines Directive (FMD).

It states that despite Brexit, FMD is ‘not going away,’ and the UK is tied to it until at least December 2020, and despite the fact that not everything will be ready by February, that does not mean that the project will stop.

The article also states that it is not too late to be ready. It notes that if companies haven’t yet started to address FMD, but are able to make quick decisions and take standard options, they can still have the software implemented within the next few months.

No-deal Brexit could hit drug supply on continent too, ABPI head warns

The Pharmaceutical Journal, Debbie Andalo, 10 August 2018 

The Pharmaceutical Journal reports that Mike Thompson, the Chief Executive of the ABPI, has warned that disruption to drug supply as a result of Brexit could also affect EU member states after Brexit.

It states that, according to Thompson, European governments have failed to recognise the impact a no-deal Brexit will have on their own medicine supply chains. He said that a no-deal Brexit would not only impact the 37 million packs of drugs imported into the UK from across the EU each month, but will also hit the 45 million packs that travel in the opposite direction from the UK to the rest of the EU.

Supply chains in France, Germany and the Netherlands would be the most vulnerable as they have the biggest share of drugs coming from the UK, he said.

Thompson added that while the drug industry understood the potential risk to supply chains across Europe, the same consensus did not exist at government-level.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

Falsified Medicines Directive: Six months, six thoughts

Securing Industry, Mark Davison, 9 August 2018

Today is exactly six months before the Falsified Medicines Directive (FMD) comes into force. On 9 February, 2019, more than thirty countries in the European Economic Area will have new rules for coding and verifying prescription medicines.

We’ve had two-and-a-half years of the three year implementation window now: what conclusions can we draw and what recommendations can be made?

1. It will happen.

Those of you waiting for Brussels or Brexit to cancel FMD are wasting your time. Even if there is a delay, FMD is not going away and the UK is tied to it until at least Dec 2020. Will everything be ready by February? No, quite clearly not, especially at pharmacy level. That doesn’t mean the whole project will stop.

2. It’s too late.

If you’re a marketing authorisation holder (MAH) and still need to convert production lines then it is too late to be ready. You have two options. You can make excess inventory, release it before February, and hope it lasts until your lines are ready, or you can send your finished goods to a contract manufacturer (CMO) for coding. Both inconvenient, but you’re still in business.

3. It isn’t too late.

There is still time to get ready if you just need software to manage and report serial numbers (e.g. to the European Medicines Verification Organisation, EMVO) or if you’re a downstream distributor or pharmacy needing to verify and decommission packs. If you haven’t started, but can make quick decisions and take standard options, ACT NOW, and you could have your software implemented within the next few months.

4. Choose experience over price.

Saving a few thousand euros using unproven but cheap serialisation vendors is a false economy if you can’t sell or dispense products by next February. It is too late for home-made solutions or inexperienced me-too suppliers. Competition means that prices are already pretty keen amongst the market leaders. Don’t chase the last cent.

5. KISS

Simple FMD projects work best. Only make system linkages you need. Usually (for manufacturers) that means MAH to CMO and MAH to EMVO. For distributors and dispensers it means to your national system (NMVO). There is the ability to integrate with your FMD solution, with the planning software, warehouse system, dispensing software or your Apple Watch if you want to. It’s not just for those items on the critical path for FMD compliance. Starting with a standalone approach as part of a roadmap to deeper integration is the best balance of risk and ROI.

6. Adapt processes, train people.

For every euro spent on vendor technology, several euros need to be spent on your own people and processes to bend them into shape. Don’t skimp on this bit. Pack-level traceability changes everything all along the supply chain. If people carry on with old ways of working your FMD project will fail: expensively.

No-deal Brexit could hit drug supply on continent too, ABPI head warns

The Pharmaceutical Journal, Debbie Andalo, 10 August 2018 

Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, has warned that disruption to drug supply as a result of Brexit could also affect EU member states after Brexit.

European governments have failed to recognise the impact a no-deal Brexit will have on their own medicine supply chains, the head of the Association of the British Pharmaceutical Industry (ABPI) has warned.

Mike Thompson, chief executive of the ABPI, told The Pharmaceutical Journal that a no-deal Brexit would not only impact the 37 million packs of drugs imported into the UK from across the EU each month, but will also hit the 45 million packs that travel in the opposite direction from the UK to the rest of the EU.

Supply chains in France, Germany and the Netherlands would be the most vulnerable as they have the biggest share of drugs coming from the UK, he said.

Thompson added that while the drug industry understood the potential risk to supply chains across Europe, the same consensus did not exist at government-level.

He told The Pharmaceutical Journal: “I think that Brexit is a high priority in the UK, more than it is in other member states. My concern is that other member states don’t quite understand that is their patients — and not just those in the UK — which need to be protected as well.”

UK drug manufacturers have, since the end of 2017, been taking steps to mitigate the impact of a no-deal Brexit, which includes preparing to hold “in excess of buffer stocks”, he revealed.

And although ministers have spoken about making it a priority to protect the UK medicines supply chain, he admitted: “It’s become difficult for either the UK government or the EU to give us any real clarity on which [Brexit] scenario we should be planning for.”

He added: “ We are working with our members to understand where the pressure points are and to make sure that we do everything we can to continue to supply medicines to patients across the whole of Europe.”

The ABPI is also calling on the UK and the EU to mutually recognise the quality assurance of drugs either side of the UK/EU borders so that drug companies do not have to invest time and money creating duplicate quality assurance systems after Brexit.

“If they continue to recognise quality assurance of manufactured products that happens in each other’s jurisdiction, that will help us to [devote time and investment] on some of the other [supply chain] issues,” he said.

Thompson’s warnings about the potential impact of Brexit on EU patient’s medicine supply follow similar comments from drug giant AstraZeneca on 3 August 2018.

Ad Antonisse, the company’s Dutch external affairs director, told the Brexitloket website: “If we do not prepare well for Brexit, patients in the EU may no longer be able to receive their medicines.”

Media And Political Bulletin – 10 August 2018

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