RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.


Regulatory Focus™ > News Articles > 2019 > 1 > EU Regulatory Roundup: Shire Raises ‘Substantial Concerns’ About ICH Guidelines

EU Regulatory Roundup: Shire Raises ‘Substantial Concerns’ About ICH Guidelines

Posted 24 January 2019 | By Nick Paul Taylor 

EU Regulatory Roundup: Shire Raises ‘Substantial Concerns’ About ICH Guidelines

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
UK Drafts Legislation to Empower Pharmacists to Mitigate Drug Shortages
The United Kingdom is set to give pharmacists more power to substitute drugs in the event of serious shortages. Once enacted, the law will enable politicians to give pharmacists the flexibility to dispense a different drug than is specified on a prescription to ensure patients can access suitable treatments.
Through the legislation, the government will enable government ministers to issue a serious shortage protocol (SSP) when supplies of a prescription-only medicine are disrupted. The issuing of a SSP will give pharmacists additional powers. Specifically, pharmacists will be able to dispense either a drug of a different strength, quantity or dosage form or a different product entirely than the medicine on the prescription.
The option to dispense a different product than is identified on the prescription frees pharmacists from legal obligations they face normally. In doing so, SSPs will open the door to the pharmacy-level replacement of prescription drugs with generics, biosimilars or therapeutically similar products.
Currently, pharmacists need to talk to prescribers before making such substitutions. Under the SSP model, physicians will develop and sign off on substitution protocols. Pharmacists will then follow the protocols, freeing them from the need to consult with physicians on a case-by-case basis.
Lawmakers included the mechanism for mitigating shortages in legislation to implement the Falsified Medicines Directive. The mechanism is unrelated to the European Union directive, but by bundling it with legislation on that topic the government has quickly advanced the SSP idea. Following a short, informal consultation, the SSP legislation is due to come into force on 9 February, the day the Falsified Medicines Directive goes live.
That means the SSP option will be in place by the time the UK leaves the EU. In its explanation of the law, the Medicines and Healthcare products Regulatory Agency said the legislation is unrelated to Brexit but added that SSPs could be used to mitigate shortages stemming from the exit from the EU.
Whether all the kinks will be ironed out by then is another question. In response to the call for feedback, the Pharmaceutical Services Negotiating Committee (PSNC) highlighted the potential for the system to add to the workloads of pharmacists. PSNC wants “appropriate training” to be offered to community pharmacists to help them adapt to the system.
The impending Brexit departure date means such training may not happen before the UK leaves the EU. PSNC also highlighted the potential for a surge in shortages after Brexit to overwhelm the capacity of the Department of Health and Social Care (DHSC) to draft and issue SSPs. The department ended 2018 with 385 fewer civil servants than it had when the UK voted to leave the EU, a decline of 20% in 30 months.
DHSC thinks post-Brexit shortages can be avoided altogether. In a separate notice, DHSC sought to reassure patients that they will be able to access drugs and devices if the UK leaves the EU without a deal. The notice states that supplies will be uninterrupted “if everyone does what they should do” but admits that, “Occasionally we do experience temporary shortages of specific medicines.”
If shortages happen as a result of Brexit, the government expects physicians to prescribe the best available alternative, as they do during supply diusruptions today. The advance of the SSP legislation means another mitigation mechanism should be active in time for any Brexit-related shortages.
Draft Legislation, PSNC Comment, Explanatory Memo, DHSC Statement
Shire Raises ‘Substantial Concerns’ About ICH Guidelines in Feedback to EMA
Shire has told the European Medicines Agency (EMA) it has “substantial concerns” about the impact of planned International Conference on Harmonisation (ICH) rules. The feedback relates to perceived discrepancies between the pharmaceutical product lifecycle management guideline and existing ICH documents.
ICH created Q12 to improve the management of post-approval changes to chemistry, manufacturing and controls. Shire and other commenters on the draft welcomed the guideline and opportunity to comment on it but brought up concerns about the compatibility of Q12 and other ICH guidelines.
“Shire notes significant discrepancies between this guideline and other related ICH guidelines,” the drugmaker wrote in feedback to EMA. “Given our substantial concerns regarding potential challenges to proper and timely adoption and implementation due to apparent misalignment, Shire urges the EMA and the ICH Expert Working Group to consider expanding, clarifying and specifying the linkage of this document to existing ICH guidelines.”
The concerns center on the compatibility of Q12 with Q8 and Q11, texts that cover pharmaceutical development and the development and manufacture of drug substances, respectively. Specifically, Shire wants EMA to work with ICH to address the application of methods and documents established during development to the commercial phase of the product life cycle.
Other commenters, including Gilead Sciences, highlighted concerns with the use of terms in Q12 that are not defined in Q8 or Q11. Gilead wants ICH to introduce the concept of key process parameters, a term used in Q12, into Q8 during the next revision of that guideline.
EMA has sent feedback from Gilead, Shire and the other commenters to ICH for consideration in the next stage of the organization’s guideline development process.
Collected Feedback
UK Politicians Discuss Restrictions to Protect Drug Stockpiles From Parallel Trade
UK politicians have debated the merits of suspending export licenses to ensure stockpiles of drugs stay in the country. The proposal is underpinned by fears that a fall in the value of the British pound could encourage parallel traders to export stockpiled medicines to the Eurozone.
The government wants the drug industry to stockpile medicines as a hedge against the potential for Brexit to disrupt cross-border trade and is investing in storage to support the efforts. However, while the UK is in the EU there is nothing to stop companies from selling stockpiled drugs to businesses in the rest of Europe.
The profits companies can reap from making such sales will increase if the value of the British pound falls against the Euro, something that is likely to happen if the UK looks set to leave the EU without a deal. As the stockpiles are in place to protect the UK against such a no-deal Brexit, there is a risk its efforts will be undermined by market forces.
In light of that risk, Jon Ashworth, a politician in the opposition Labour Party, asked the government whether it will impose restrictions and suspend export licenses to ensure stockpiled drugs stay in the UK. The government gave a noncommittal answer.
“We have the legislative tools and powers the honorable Gentleman describes at our disposal. We know that,” Matthew Hancock, the secretary of state for health and social care, told parliament.
Ashworth thinks that if the government has the power to protect stockpiles it should use them now as the UK faces the “biggest disruption to patient safety we have ever seen.” The government still hopes to ensure there is no disruption by getting a version of its withdrawal agreement with the EU through a vote in parliament.
Debate Transcript
Other News:
The Danish Medicines Agency (DKMA) has outlined its position on data protection and social media. DKMA stated it “only uses social media to the extent that we consider it safe from the perspective of data protection.” DKMA Notice

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Regulatory Focus™ is doing essential, non-biased journalism during this unprecedented time. We appreciate your support as we bring you the news and intelligence you need to make an impact on global healthcare.

Regulatory Focus™ provides the intelligence you need to impact global healthcare during this crisis. Thank you for your support.