Is Europe ready for serialisation?
Christoph Krahenbuhl, Packaging Today, 3 July, 2017

February 2017 marked the two year countdown to the implementation of the Falsified Medicines Directive (FMD), but Krahenbuhl questioned whether this is a reasonable timeline. He stated in particular that wholesalers will be required to “establish technical capabilities to handle serialised products”, which is a new burden not before placed on distributors. He also noted that the significant work needed to be done to design and build distribution systems in the 32 countries covered by the FMD had yet to be undertaken. What is clear is that, regardless of Brexit, FMD has brought with it several unanswered questions for Europe and the UK.

UK ministers call for post-Brexit co-operation with EU on drugs
Financial Times, Sarah Neville and Jim Pickard, 3 July, 2017

The Health Secretary, Jeremy Hunt, and the Business Secretary, Greg Clark, have written to the Financial Times stating their intention to “find a way to continue to collaborate with the EU, in the interests of public health and safety” in the context of drug regulation. The pharmaceutical industry had called for certainty around drug manufacturing and regulation, and the letter was warmly received by the sector. Some had worried that a separate regulatory scheme would have forced the UK to “the back of the queue” when it came to the approval of new medicines. Currently, drugs are approved through the European Medicines Agency (EMA), and then distributed to member states. After Brexit, the preferred position of the industry is to continue at least the first approval phase through the EMA. The letter to the Financial Times was counter-signed by Downing Street, the Treasury and the Brexit Department.

MPs keen for close collaboration with EMA post Brexit
PharmaTimes, Selina McKee, 4 July, 2017

PharmaTimes further reported that the Chief Executive of the British Pharmaceutical Industry, Mike Thompson, said that the letter in the Financial Times “signals a readiness to take a pragmatic approach to the Brexit negotiations that puts people’s health first”. Another sign that the current trajectory is welcomed by major pharmaceutical players.


Answered on: Monday 3 July 2017
Written Question: HealthTim Farron (Westmorland and Lonsdale):

What contingency plans are in place in the event of a licensed medicine becoming unavailable owing to temporary shortage.

Steve Brine (Parliamentary Under-Secretary of State):
There is a team within the Department which deals specifically with medicine supply problems, both in the community and hospitals. It works closely with the Medicines and Healthcare products Regulatory Agency (MHRA), the pharmaceutical industry, NHS England and others operating in the supply chain to help prevent shortages and to ensure that the risks to patients are minimised when they do arise.

This work is underpinned by joint Departmental/pharmaceutical industry best practice guidelines which give advice to companies on what to do in the event of a shortage. In the event of a shortage, the Department will explore the available options for continued supply, which might include: investigating alternative supplies, expediting regulatory decisions, commissioning clinical advice and ensuring that appropriate communications channels are in place to alert health care professionals. Many potential shortages are resolved before they can have an impact on pharmacies or patients.

The Department also holds an Essential Medicines Buffer Stockpile, which is in place to make the supply chain more robust for key medicines in the event of a pandemic or other emergency.


Is Europe ready for serialisation?
Christoph Krahenbuhl, Packaging Today, 3 July, 2017

Pharmaceutical manufacturers supplying the European market and their supply chain partners have seen an important milestone pass earlier this year. February 2017 marked the beginning of the two-year countdown until the EU Falsified Medicines Directive (FMD) compliance mandate comes into force across Europe.

From that date, pharmaceutical companies can no longer legally put products on the European market unless they comply with the three critical “safety feature” requirements. That every pack of medicines will be firstly tamper-evidenced, secondly carrying a 2-D data matrix encoding a Unique Identifier (UI), and finally the UI must have been uploaded into a Europe-wide system of repositories for check out at pharmacies.

Preparing to comply with these requirements is a huge undertaking and the question being asked is, “How realistic is the prospect that Europe will be ready in February 2019?” To answer the question, let’s look at this as a project – a big, complex project that involves many different stakeholders who each have to do their part and be ready on time.

Despite plenty of evidence to the contrary, big, complex projects can actually be brought to a successful conclusion, in the hands of experienced professionals, following best practice and using the right tools. The question is: what is the state of the EU European FMD Readiness Project if we apply these perspectives?

 Breaking the problem down

The starting point, as every experienced project manager knows, should be a critical early project deliverable: to define a breakdown structure that organises the project into manageable chunks of work. So let’s consider the major chunks of work that need to be undertaken to achieve EU-wide FMD compliance.

The first major area of work is the obligation on all manufacturers producing for the European market to be ready to apply the safety features described above. Without the capability to routinely serialise their products, to apply tamper-evidence and to manage the serial numbers securely, they will simply be out of business.

Once the FMD has come into force, the definition of a “quality product” will change fundamentally from today’s definition to a “Good Pack 2.0”, adding the requirement that for every pack in the market, the corresponding UI must be available  –  for the duration of its shelf-life  –  in the relevant repositories for verification in the pharmacy.

Wholesaler or distributor supply chain partners are also required to establish technical capabilities to handle serialised products, because there are a number of scenarios where they will need to scan UIs against the repositories for verification – or even check out. The scenarios where this legal obligation applies include risk-based verification, export from Europe and early dispensing in certain situations.  The other group of stakeholders that need to implement new technology are  pharmacists, who will be legally obliged to scan every pack of medicines dispensed to the public.

Another major area of work covers setting up the Europe-wide infrastructure of “repositories systems” specified in the directive. This is a task that is delegated to the industry stakeholders, some of whom – the pharmaceutical manufacturers – are also required by law to fund these systems.

This is a significant amount of work that includes not just the design, build and implementation of interconnected systems to cover the whole of Europe from manufacturer to dispense point. It also includes setting up supporting organisation structures and business processes, at national and European level, in each of the participating 32 countries.

 Are we ready?

The FMD is an ambitious requirement and the practical challenges of implementation across 32 countries with their diverse backgrounds, practices and requirements are daunting. But while it is true that there are still many details to be worked through, the basic requirements are very clear and have been published for over half a decade now.

The roadmap for achieving FMD readiness should be well known and in some areas good progress has been made, notably the establishment of medicines verification infrastructure consisting of the European Hub and National Systems. It now remains for all other stakeholders to step up to the challenge.

The anniversary of the publication of the Delegated Regulation is a good reminder that time flies. Everyone involved in the supply of pharmaceutical products to patients in Europe will need to focus on the ultimate goal: to ensure the provision of safe medicines to every European citizen.

UK ministers call for post-Brexit co-operation with EU on drugs
Financial Times, Sarah Neville and Jim Pickard, 3 July, 2017

Two senior UK ministers have warned hardline Brexiters they should be ready to accept some continued regulation from Brussels, writing that Britain’s life sciences sector needs collaboration with the EU’s drug regulator after Brexit. In a letter to the Financial Times, Jeremy Hunt, health secretary, and Greg Clark, business secretary, said that in order to shore up investment in the industry, “the UK would like to find a way to continue to collaborate with the EU, in the interests of public health and safety”.

The ministers said the proposal was in line with prime minister Theresa May’s desire for “deep, broad and dynamic co-operation” with the EU after Britain exits. But it also takes the unusual step of publicly spelling out their negotiating position before EU divorce talks are fully under way. Pharmaceutical industry leaders have been calling for a clear outline of the government’s stance, fearing that continuing uncertainty could sap global confidence in the UK medicines sector. Investment in life sciences generates more than £60bn a year for the UK economy and supports 220,000 jobs.

Some executives worry that if the UK is forced to develop its own drug approval system, divorced from the rest of the EU, Britain may find itself at the back of the queue for new medicines because drug companies will concentrate on securing approval in bigger and more lucrative markets.

The ministers wrote that, if they are unable to secure “our desired relationship with the EU”, Britain would be required to “set up a regulatory system” to process drug licenses “as quickly as possible”. Government insiders said the letter from Mr Hunt and Mr Clark has been signed off by Downing Street, the Treasury and the Department for Exiting the EU. However, in political circles it is likely to reinforce the perception that cabinet ministers are now prone to “freelancing” after Mrs May was weakened by the Conservatives’ disastrous general election result.

The new lack of discipline has meant ministers have felt freer to express their views on Brexit in particular. Boris Johnson, foreign secretary, Philip Hammond, chancellor, and David Davis, Brexit secretary, have all set out varying visions for Britain’s post-Brexit relationship with the EU. Mr Johnson and Mr Hammond have also been part of a recent cabinet free-for-all over public sector pay.

The European Medicines Agency, based in London’s Canary Wharf, currently reviews the safety of all medicines produced in the EU. Each member state also has its own national regulatory agency. But the EU medicines agency will leave London when Britain exits the EU, creating uncertainty about whether the UK will have to develop its own freestanding system for drug approvals. Under the current system, a drug first goes through a scientific assessment phase, conducted by the EMA. The European Commission in Brussels then decides whether to authorise the medicine to be used in all member states. One option favoured by the industry would be for the UK to continue to participate in the first phase — via its national agency, the Medicines and Healthcare Products Regulatory Agency — and when a recommendation has been agreed, separate but identical proposals would be sent to Brussels and London for authorisation.

This would allow the UK government to issue its own approval under domestic law that would not be governed by the European Court of Justice. Britain will have to maintain or replace the work of at least 34 European regulators after it leaves the EU, ranging from financial services, through chemicals and plastic to life sciences. Pharmaceutical industry leaders welcomed the intervention by Mr Hunt and Mr Clark. Steve Bates, chief executive of the BioIndustry Association, described the letter as “good news for patients, industry and investors”. Philip Thomson, president of global affairs at GlaxoSmithKline, said the “clear intention to prioritise patient safety and provide stability for the life science industry through the Brexit process is very welcome”. Pascal Soriot, chief executive of AstraZeneca, said securing an agreement with the EU “that enables innovative companies like ours to access scientific talent and rely on efficient supply chains as well as integrated medicines regulation will be critical to our sustainable success”.

Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, praised the government for “making the first move”, but said an agreement should be reached quickly given the industry’s very long timelines for drug development. “While I understand that the current plan is not to agree anything until everything is agreed, that just won’t work for us and therefore we would very much hope that . . . we will get an early signal in terms of the arrangements we put in place to ensure the supply of medicines,” he said.

MPs keen for close collaboration with EMA post Brexit
PharmaTimes, Selina McKee, 4 July, 2017

British MPs say they are keen to secure a close working relationship with the European Union on drug regulation post Brexit to protect patient health and investment in the UK’s life sciences sector.

In a letter to the Financial Times, health secretary Jeremy Hunt and business secretary Greg Clark stressed that “the UK would like to find a way to continue to collaborate with the EU, in the interests of public health and safety”.

A key concern for the industry is the UK’s potential loss of European Medicines Agency membership and the delays to drug approvals a separate regulatory system could bring.

As a report by The Economist warned that last year, the fear is that post-Brexit the UK would no longer provide the ideal point of entry to European markets.

“Instead it would be just one isolated European market that cannot be entered using the EU centralised drug authorisation pathway,” which means that “business opportunities for healthcare suppliers would become less attractive,” and “regulations governing registration and trade would be more cumbersome, increasing the cost of doing business”, it argued.

In their letter, the MPs said if Brexit negotiations fail to secure the desired relationship with the EU, the UK would have to establish its own regulatory system for drug approvals “as quickly as possible”, but stressed that the overall aim “is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines.”

Mike Thompson, chief executive of the British Pharmaceutical Industry, said the letter “signals a readiness to take a pragmatic approach to Brexit negotiations that puts people’s health first. This is a great first step and we look forward to seeing more detail in the coming weeks and months.

“The timeframes we need to meet to ensure no disruption or delay mean that confirmation of a reciprocal approach from the EU would provide welcome certainty to more than 500 million patients.”


From Factory to Pharmacy

As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.

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