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HDA UK Media And Political Bulletin – 17 May 2018

Media and Political Bulletin

17 May 2018

Media Summary

Life Sciences sector responds to BEIS Committee report on the impact of Brexit on the pharmaceutical sector

ABPI, 17 May 2018

 

The ABPI has responded to the report published by the Business, Energy and Industrial Strategy Select Committee which calls on the Government to secure a post-Brexit deal to protect patients and the UK’s pharmaceutical industry.

A joint statement by the Association of the British Pharmaceutical Industry (ABPI) and the UK BioIndustry Association (BIA) – whose chief executives, Mike Thompson and Steve Bates, provided evidence to the Committee – said:

“Every month, 45 million packs of medicine move from the UK to the EU, with 37 million moving the other way.

“Today’s Select Committee Report is right – a Brexit ‘no deal’ would significantly damage public health, patient access to medicines and the UK’s leading pharmaceutical sector. This must be avoided at all costs.

“Securing cooperation on the regulation, trade and supply of medicines must be a priority for both the UK Government and the EU.”

 

How Brexit could increase drug prices

Politico, Carmen Paun, 14 May 2018

 

Politico reports that drugmakers, regulators and patient groups remain very worried about what Britain’s exit from the EU will mean for the way medicines are approved on both sides and how that will affect drug supplies. One highly sensitive issue is how much medicines will cost after Brexit.

In terms of regulatory costs, it is still far from clear whether Britain will remain part of the bloc’s drug regulation system after the Brexit transition period (due to finish in December 2020), the publication continues.

Prime Minister Theresa May said in her Mansion House speech in March that she would like the U.K. to be an associate member of the European Medicines Agency, which assesses applications for marketing authorizations for new drugs. But that suggestion has so far received a cold shoulder in Brussels.

The article goes on to quote Martin Sawer, Executive Director of the Healthcare Distribution Association, who reiterates that if drugmakers have to follow new, parallel regulations in the U.K., this could increase the cost of medicines.

Parliamentary Coverage

House of Commons Business, Energy and Industrial Strategy Committee publishes report on the impact of Brexit on the pharmaceutical sector, 17 May 2018

The House of Commons, BEIS Select Committee has published its report following an inquiry into the impact of Brexit on the pharmaceutical sector. The report calls on the Government to secure a post-Brexit deal to protect patients and the UK’s pharmaceutical industry.

The recommendations from the committee include securing the closest possible regulatory alignment with the EU27 post-Brexit as well as ensuing minimum border friction.

To read the full report, please follow this link.

 

Full Coverage

Life Sciences sector responds to BEIS Committee report on the impact of Brexit on the pharmaceutical sector

ABPI, 17 May 2018

 

‘The impact of Brexit on the pharmaceutical sector’ makes several recommendations which industry welcomes. This includes the need to secure the closest possible regulatory alignment with the EU as well as minimum border friction. Patients are at risk of harm and the UK pharmaceutical sector could lose its status as a world leader, the report says.

The Committee also concluded that “what little benefits there may be from regulatory divergence, these would be greatly overshadowed by the costs and loss of markets and influence the UK would face.”

A joint statement by the Association of the British Pharmaceutical Industry (ABPI) and the UK BioIndustry Association (BIA) – whose chief executives, Mike Thompson and Steve Bates, provided evidence to the Committee – said:

“Every month, 45 million packs of medicine move from the UK to the EU, with 37 million moving the other way.

“Today’s Select Committee Report is right – a Brexit ‘no deal’ would significantly damage public health, patient access to medicines and the UK’s leading pharmaceutical sector. This must be avoided at all costs.

“Securing cooperation on the regulation, trade and supply of medicines must be a priority for both the UK Government and the EU.”

 

How Brexit could increase drug prices

Politico, Carmen Paun, 14 May 2018

 

When Health Secretary Jeremy Hunt wrote last month that there were “gilt-edged opportunities” for health from Brexit, he probably didn’t have drug companies charging more for medicines in mind.

Drugmakers, regulators and patient groups are busy worrying about what Britain’s exit from the EU will mean for the way medicines are approved on both sides and how that will affect drug supplies. One highly sensitive issue is how much medicines will cost after Brexit.

Any increase could hit the U.K.’s already stretched National Health Service, soaking up funds and forcing cutbacks elsewhere in the service. That would not sit well with the promises of Brexiteers to release money from the U.K.’s contributions to the EU budget to be spent on the NHS.

Manufacturers of branded drugs don’t think Brexit will impact drug prices, but other industry players are worried that Brexit will lead to increases.

Here’s how Brexit could hit the price of medicines:

Ending parallel imports from the EU

Licensed distributors can now buy cheaper medicines from one EU country and resell them for more in the U.K. The EU rules allowing them to do so are based on the principle of free movement of goods within the bloc’s single market.

Unless the U.K. and the EU find an agreement to maintain the flow of cheaper medicines through parallel imports into the U.K., the practice would stop with Brexit (assuming the U.K. rejects the so-called Norway option of continued single market membership).

That will potentially lead to less competition and higher prices, according to Richard Freudenberg, secretary-general of the British Association of European Pharmaceutical Distributors (BAEPD).

“Parallel imports are the only price competition Big Pharma has for on-patent drugs,” he said. Drugmakers can launch their new medicine in the U.K. at a certain price, but parallel importers compete with them by buying the same drugs cheaper in other European countries. This competition depresses the list prices drugmakers ask in the U.K.

According to the BAEPD’s submission to an inquiry by the House of Commons health committee, the list prices for drugs in the U.K. are currently at least 3 percent lower than they would be without the existence of parallel trade. “The impact for launch prices of medicines will be affected by an absence of parallel imports in the future,” said Freudenberg. Not everyone agrees.

“I don’t see it,” said Richard Torbett, executive director for commercial policy at ABPI, the British lobby defending the interests of branded drugs manufacturers. He said the competition is fiercer between two branded medicines that treat the same disease than between a medicine that is placed on the market directly by the manufacturer and the same one coming from parallel imports.

Torbett doesn’t see Brexit affecting drug prices, since the process of pricing a new branded medicine “is based around the value of a medicine rather than the cost of manufacturing,” he said.

Regulatory costs

With Brexit negotiators only now beginning to tackle questions about the U.K.’s future relationship with the EU in earnest, it is far from clear whether Britain will remain part of the bloc’s drug regulation system after the Brexit transition period (due to finish in December 2020).

British Prime Minister Theresa May said in her Mansion House speech in March that she would like the U.K. to be an associate member of the European Medicines Agency, which assesses applications for marketing authorizations for new drugs. But that suggestion has received a cold shoulder in Brussels.

If drugmakers have to follow new, parallel regulations in the U.K., this could increase the cost of medicines, said Martin Sawer, executive director at the Healthcare Distribution Association, which represents medicines and medical devices distributors.

For generic drug manufacturers, even if the U.K. were to remain within the EMA they will have to deal with an extra regulatory burden. That’s because many of these drugs are certified at the national level, not by the EMA. The legal and logistical changes they will need to undertake before Brexit are likely to have an impact on prices.

The U.K. drug agency handled many approvals of generic medicines through the so-called decentralized procedure by which an EU country approves a drug and others then recognize it as approved in their country as well. Generic manufacturers will now have to transfer the files held by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to other EU countries’ agencies.

“This takes time and costs money,” said Adrian van den Hoven, director general at Medicines for Europe, the EU generics pharma lobby.

Transferring the quality assurance system from the U.K. to the rest of the continent will also be a logistical and cost burden, he said. All medicines or active pharmaceutical ingredients on the EU market need to be released by a qualified person who can attest that they fulfil all regulatory requirements and standards.

One challenge is that many of the active ingredients imported into Europe first go to the U.K, where they are laboratory tested and then released EU-wide, Van den Hoven said.

Without an agreement, all of this would have to be done somewhere in the EU, meaning the need for new laboratories that would have to be certified within a tight timeframe, which could in turn have a major impact on the supply of some medicines into the EU, he said.

“This could lead to shortages and in a market based on supply and demand, a huge temporary impact on cost,” Van den Hoven said. In the long term, the money used to build new labs in the EU would be reflected in the medicine prices, he said.

HDA UK Media And Political Bulletin – 17 May 2018

From Factory to Pharmacy

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