Why Malta’s medicines can fail on Brexit day

There are many aspects of Brexit that will cause havoc in the European Union once 31 March 2019 arrives. Transportation, supply chains, aviation – the list is endless. One of the big Brexit problems Malta faces is its supply of medicines.

I

There’s a simple question behind any Brexit related article – after Brexit, how will we continue to do things? It’s a question both sides are asking because it will affect everyone.

Transportation hubs worry the bureaucratic delays will cause long queues on motorways. Businesses on either side of the English channel worry about how to continue selling to each other. I’ve written about how Brexit threatens Air Malta’s existence and that’s a thought I hope keeps some people awake at night.

The regulatory nightmare is one of the big hidden issues Brexit will bring. To be clear, we still don’t know what the Brexit agreement will look like so maybe it will all be rosy.

I don’t know what will happen.

And neither do you.

Many businesses are making contingency plans to be sure they’re covered. Last week (22 June) Airbus announced it was on the verge of reconsidering its UK operations due to the lack of clarity on Brexit.

I hope governments are working on contingency plans.

Is that too optimistic of me?

II

The Maltese medicine market is a case in point. We import almost all our drugs from the UK because drugs manufactured there have English language leaflets. English is one of our national languages.

We can import drugs from other EU countries because there is a common market. If you can sell something in the common market, you can sell it in Malta too. There is some oversight when it comes to medicines. It’s not like you’re importing something simple, like pencils.

Malta’s Medicines Authority or the European Medicines Agency must authorise any medicine marketed here. This is not a lengthy process but it is necessary to make sure certain standards are upheld. Everyone can agree that, with medicines, we need to take care to ensure standards are in place and maintained.

With Brexit, the European Union will no longer accept drugs manufactured in the UK. The Union will test any UK-produced drug because it will be no different to a random drug produced in, say, China. If the UK decides to change its standards, which it can do, then the process to import UK drugs will be longer.

And the drugs will also cost more.

The EMA has published advice for British suppliers to allow them to continue to sell their medicines to the Union after Brexit. The documents are up-to-date (as of time of writing, the latest update was 19 June 2018). In a nutshell, anyone wishing to trade with the Union must have an EU office of some sort. If you’re interested in the details I suggest you look at the EMA’s Brexit-related guidance for companies.

Is the Maltese government preparing contingency plans for Brexit?

How will this affect Malta?

III

Malta holds a stock of some medicine, like any country. It’s easy to fill a warehouse with a stockpile of simple over-the-counter products like aspirin. It’s not easy to stockpile rarer medicines, or ones which are rarely used.

This means Malta needs a contingency plan to buy medicines from an alternative source. I’m not sure if European manufacturers find Malta interesting when compared to the size of their other clients. If we issued a tender now (June 2018), we could go through the procedures and Malta could select one or more new suppliers by the end of 2018.

If all goes well.

Malta imports most of its drugs from the UK. No one knows how Brexit will affect this.

But Malta has not launched any such requests for tenders.

This doesn’t mean there aren’t ways of getting hold of medicines. The Emergency Procurement Regulations allows Malta to buy things it needs in cases of emergency. We can dispute what the term ’emergency’ should cover. If Brexit means we cannot buy medicine under normal rules, I think you’ll agree that is an emergency.

This mechanism is already well-used as the government’s Competitive Calls website shows. This is a good thing because it means the people involved already know the mechanism to use and are familiar with the procedures.

Is it as easy as this? Can we just buy stuff from somewhere else?

IV

Perhaps a more pertinent question is ‘would a European supplier be interested in translating their information into Maltese or English for us?’ My guess is they wouldn’t. I figure it would be simpler and easier for Malta to translate the leaflets itself. It doesn’t matter who translates the information as long as its done. We’ll pay more for drugs because of this added cost, so we might as well go for the simpler (and cheaper) option. If the cost is not prohibitive, there’ll be a potential delay.

Malta has to wait for the Brexit deal to see what will happen. Time is running out.

Either way, we’ll pay for this step.

People will soon get used to the new brands, as will doctors. There will be some initial concern about brands Maltese doctors are unfamiliar with. This will not be a problem for long because if doctors on the continent use them there’s no reason Maltese doctors can’t.

So is this a problem or not?

V

I can’t say.

It will hinge on what the Brexit deal will look like.

Are you ready for more expensive medicines because of Brexit?

As a result, I think it’s fair to conclude that:

1. Malta will have to scramble to make sure it has continuity in its medical supplies. Malta has the means to buy supplies from the continent. Has it reached out to potential suppliers to see about practicalities like translations? Has it started diversifying its suppliers? There is no published news about this.
2. Wherever we get our drugs from, they are going to be more expensive as of 31 March 2019. Either we’ll still buy from the UK and pay some importation charge, or we’ll buy from the continent and pay for translation fees.

Are you ready for a hike in the cost of your medicines? What medicines do you depend on?

Share this article with someone who depends on medicines because they deserve to know what’s happening.

References

1. Airbus prepares to move from Britain over Brexit fears; Francis Elliott, Robert Lea, Oliver Wright; The Times; 2018-06-22
2. British drugs face Brussels ban; Sabah Meddings; The Times; 2017-10-01
3. Brexit-related guidance for companies; European Medicines Agency (Retrieved 2018-06-28) 
4. Procedural guidance to help pharma companies prepare for Brexit; European Medicines Agency; 2017-11-28
5. United Kingdom’s withdrawal from the European Union (‘Brexit’); European Medicines Agency; (Retrieved 2018-06-28)
6. Questions and Answers related to the United Kingdom’s withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the Centralised Procedure; European Medicines Agency; 2018-06-19
7. Emergency Procurement Regulations; Ministry of Justice; 2016-10-28

All references were valid and correct when this article was published. Changes to referenced websites or web pages may render some references invalid. If this is the case, please leave a comment below.