UK-US post-Brexit trade deal risks increased drug prices

US-UK bilateral trade deal is a key post-Brexit priority, with conversations already taking place to achieve this.

Advertisements

A trade deal between the UK and USA could risk increasing drug prices in the UK, which could diminish the affordability and accessibility of the NHS, according to a Viewpoint published in The Lancet.

The opinion piece outlines how the USA’s targeting of so-called ‘foreign free-riding’ in trade deals could lead to a poor deal on pharmaceuticals for the UK post-Brexit. The authors raise concerns that the USA could pressure the UK to change the way it regulates pharmaceuticals in trade deals.

Currently, all of the UK’s international trade deals are negotiated through the European Union, but, the UK Government will need to negotiate new deals to replace existing agreements post-Brexit. The USA is one of the UK’s most important trading partners after the rest of the European Union, and a US-UK bilateral trade deal is a key post-Brexit priority, with conversations already taking place to achieve this.

US policies to reduce ‘foreign free-riding’

American drug prices are some of the highest in the world, leading to economic hardship and poorer health outcomes for uninsured Americans and those who cannot afford to pay out-of-pocket. The US Government does not negotiate drug prices, and Medicare is prohibited by law from doing so. In addition, the Affordable Care Act prevents the US Food and Drug Administration and the Secretary of Health and Human Services from basing drug approval decisions on cost-effectiveness.

By contrast, similar drugs are often significantly cheaper in the UK, where the Government negotiates prices with pharmaceutical companies via the Pharmaceutical Price Regulation Scheme, and the NHS makes purchases based on clinical and cost-effectiveness assessments from the UK’s National Institute for Health and Care Excellence (NICE).

In May 2018, the US Department of Health and Human Services introduced the American Patients First blueprint, outlining measures to reduce US drug prices which include putting pressure on other countries to allow drug prices to rise in their jurisdictions. Unveiling the new policy, President Trump stated that “as we demand fairness for American patients at home, we will also demand fairness overseas. When foreign governments extort unreasonably low prices from US pharmaceutical companies, Americans have to pay more to subsidise the enormous cost of research and development”.

The Trump administration blueprint criticises single-payer healthcare systems which impose drug price controls, and accuses foreign governments of not paying their fair share of research and development costs to bring innovative drugs to market – proposing that other nations ‘free-ride’ off of American investment in drug development.

However, the Viewpoint authors argue that this interpretation overlooks the high cost of drugs for patients, and that drugs should be priced in line with how much benefit they give. They raise concerns that, rather than tackling the inherent issues of funding drug development, American Patients First instead represents the interests of pharmaceutical companies and their stakeholders, aiming to maintain or increase revenues.

“American Patients First is an attempt by the Trump Administration to make the USA’s drug pricing problem everybody else’s problem,” says lead author Dr Holly Jarman, University of Michigan, USA. “By shifting the economic, political, and social costs of policies made in the USA onto America’s trading partners, the Trump Administration is attempting to show voters that they are doing something about high drug prices while providing benefits to pharmaceutical companies and sympathetic campaign donors.” [1]

Potential effects for the UK post-Brexit

With the American Patients First policy and a turn towards protectionist, pro-American trade deals, the authors believe that the USA will push to alter drug regulation in future trade negotiations with the UK. This raises concerns because the ability to enter into trade deals is an executive power in the UK.

One of the authors, Professor Tamara Hervey, University of Sheffield, UK, points out: “While deals have to be ratified by Parliament, Parliament cannot amend the agreement that the Government negotiates, or be directly involved as the negotiation takes place. In addition, health groups are rarely consulted on trade deals, and Parliament and other health-focused stakeholders have limited opportunities to hold the Government to account in its trade negotiations.”

This is also exacerbated by the Brexit process. The Trade Bill introduced this year – if passed into law – could further limit parliamentary and public scrutiny of US-UK trade deals.

In addition, until recently the UK did not have a fully functioning trade ministry capable of complex negotiations with a highly experienced country like the USA. The authors say that the UK is unlikely to get a better deal with the USA than it has as part of the European Union, as the UK market is much smaller than the whole of the EU, meaning the UK has less bargaining power in negotiations.

Lastly, the authors raise concerns that pharmaceuticals will be one part of a wider trade agreement between the UK and USA, and could be an area that the UK compromises on to ensure better deals elsewhere.

“Perhaps the ultimate issue is the extent to which UK politicians are willing to defend the existing regulatory regime in the context of risks to their political careers,” says Professor Martin McKee, one of the authors from the London School of Hygiene & Tropical Medicine, and member of the advisory board of Healthier In (an NGO which campaigned to remain in the EU).

He continues: “In view of President Trump’s recent trade policy actions, policy makers should take the administration’s argument over drug prices very seriously. The UK health policy community should press the UK Government to make clear to the public and to the USA that they are not willing to bring the UK’s drug pricing and evaluation regime to the negotiating table in any future UK-US trade talks.”

http://bit.ly/2L5l2Nn Read more here

National health targets lead to perverse outcomes

Those health targets were such a miserable failure that we have to find something that works and that’s better.

National has warned that there will be more preventable deaths in the health system now that the Government has dropped national health targets.

The performance targets for district health boards, which the former government introduced in 2009, have been stopped by the Coalition Government, and no data has been published since August 2017.

“Over time dropping the targets, losing the accountability, will mean more illnesses and more fatalities in our health system that could have been avoided,” National leader Simon Bridges told reporters today.

But Ian Powell, executive director of the Association of Salaried Medical Specialists, said that was not true.

“That’s crap. The obsessional nature of certain targets has contributed to some patients going blind,” he said.

Powell said the targets had not worked and they needed to be outcomes–based.

“They have led to superficial assessments of how the system has performed, they grossly mislead the public and they have had, especially in the context of underfunding, very perverse outcomes.

“The [Health] Minister, and we would agree with him, is looking more towards things that focus more on improved health outcomes,” he said.

Acting Prime Minister Winston Peters said the targets had been a “miserable failure”.

“It’s not correct to say we’ve dropped health targets. I just think those health targets were such a miserable failure that we have to find something that works and that’s better,” Peters told reporters this morning.

Health Minister David Clark said the Ministry of Health had stopped publishing data based on the previous government’s targets while other measures were developed.

“The previous government’s targets produced perverse incentives leading to what were traditionally cheaper surgeries being performed in more expensive environments. That meant the health dollar was not being spent as wisely as it could be,” Clark said.

“I want a health system that has honest and transparent measures, unlike the previous Government, which was pumping up its numbers by counting Avastin injections [used to treat eye disease] and skin lesion removals as surgeries when many could have been done in primary care.”

http://bit.ly/2Kbi2iP

How to Effectively Manage CROs/Vendors used in the [Pharmaceutical Industry]

It is imperative for pharmaceutical companies that outsource to get a thorough understanding of the elements of a sound outsourcing system.

Today’s globalized and interconnected world has made outsourcing indispensable. Outsourcing works to the benefit of both parties. Those who outsource can let other, independent companies, usually those that have specialized in this function, to take over several of their secondary processes, so that they can concentrate on the more productive and business-yielding activities. At the other end, the outsourced company earns substantial revenues by carrying out outsourced activities.

In the pharmaceutical industry, it is necessary and important to employ efficient and accurate strategies for this important activity. When projects are outsourced without proper safeguards and monitoring going into them, the outsourcing company has higher chances of inviting FDA actions such as Warning Letters, 483’s, etc.

Putting a selection process in place is very important

Companies should put in place robust structures that help them select vendors successfully and avoid scenarios such as these. These systems should also ensure that other critical aspects of outsourcing activities in GXP areas such as contract design, quality monitoring and risk minimization remain compliant. It is imperative for pharmaceutical companies that outsource to get a thorough understanding of the elements of a sound outsourcing system.

blogpic-129

Complete learning on how to select CROs/Vendors

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will educate participants on the elements of managing and avoiding common pitfalls with CROs/Vendors.

Laura Brown, an independent Pharmaceutical Project Management and Training Consultant and is Course Director for the M. Sc. in Clinical Research at University of Cardiff’s School of Pharmacy; will be the speaker at this course.

Dr. Brown has over 20 years’ experience of managing clinical research projects in the pharmaceutical industry. She has worked in Project Management for several companies including Wellcome, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She is also co-author of two books on Project Management, including Pharmaceutical Project Management, a 2004 publication.

Please enroll for this webinar by visiting http://bit.ly/2JJHZVz

Learning on all elements of CROs/vendor outsourcing

At this webinar, Dr. Brown will combine theory and practical examples to offer a crucial overview of a sponsor’s responsibilities, which will give them the knowledge needed to ensure quality oversight.

In the course of this session, Dr. Brown will cover the following areas:

  • Understand how to Effectively Manage CROs/Vendors used in the Pharmaceutical Industry
  • Build an Understanding of your Responsibilities as the Sponsor or the Vendor: Identifying the Right Level of Management and Oversight
  • Discover Tools and Processes to Manage CROs/other Vendors
  • Gain an insight for CROs/other Vendors of what Sponsors Expect and how to Meet their Expectations
  • Measuring CRO Performance including Metrics and Key Performance Indicators
  • Managing and avoiding common pitfalls with CROs/Vendors.

Personnel who work in areas that involve one or more aspects of outsourcing CRO’s/vendors, such as Vendor Management, Global QA/Compliance, Contracts and Outsourcing, VPs, Directors, Outsourcing Department Staff, Purchasing, Finance and Contract, Management Staff, Managers and other personnel involved in selecting and managing cross, will benefit from this course.

Dr. Brown’s webinar is also aimed at helping personnel involved in vendor/CRO/CMO oversight (including those working in Clinical Research, Regulatory Affairs Pharmacovigilance, and Manufacturing) in the pharmaceutical, biotechnology, medical device and biologic industries who use Contract Research Organizations (CROs/CMO).

For more interesting topics Follow this

Executive Council hears pitch to overhaul N.H.’s state retiree health care plan

Presenting the plan, DAS Commissioner Charlie Arlinghaus called it an opportunity to save money and keep the program viable.

The New Hampshire Department of Administrative Services (DAS) is proposing a sweeping overhaul of the state’s retiree health care plan, seeking to switch users into a Medicare program that officials say could help the state save $11.8 million through 2020.

The proposal, presented to the Executive Council on Wednesday, would move the state’s 9,600 Medicare-eligible public retirees off their present plan – a state-funded program called “Medicomp” – and onto a federal initiative known as Medicare Advantage.

That move would allow the state to take advantage of a higher federal match rate under Medicare Part C, the Medicare Advantage program. The proposal would reduce projected costs from January 2019 to December 2020 from $41 million to $29.2 million, according to the department.

Rl7a

Anthem health insurance would continue administering care for retirees, but under a new funding structure overseen by the federal government.

The proposal comes as the state has struggled to keep up with rising health care costs in its retiree health plans, forcing legislators to address multiple budget shortfalls in recent years, according to the department.

Presenting the plan, DAS Commissioner Charlie Arlinghaus called it an opportunity to save money and keep the program viable. And he said no patient would lose his or her doctor or experience a change in benefits.

“The doctors you will be able to go to are anyone who takes Medicare,” he said. “Which, theoretically, if you’re already in the Medicare program, that’s who you’re using now.”

Under the proposal, Medicare-eligible retirees would receive insurance through Anthem, which would in turn be reimbursed by the federal Centers for Medicare and Medicaid Services on a per-person basis.

The rate would be determined by the health of the people being served and the quality of the care offered, incentivizing Anthem to improve its service, according to the department. By working under Part C of the Medicare program, retirees would benefit from a coordination between Medicare parts A and B, which cover hospital expenses and provider costs, respectively, and Part D, which covers pharmaceuticals.

“Other than the increased attention to the care retirees are receiving, members should experience minimal disruption while continuing with the same level of medical coverage with the flexibility to see the same Medicare participating providers they see today,” Arlinghaus wrote in a letter accompanying the proposal.

The plan comes months after Anthem announced that it had expanded its presence in the state enough to leverage more federal dollars through the Part C program and lower premiums, the department said, a major factor in the cost savings to the state.

And it comes in response to years of struggles with the state’s retiree health care service.

In 2015, the Joint Legislative Fiscal Committee struggled to plug a $10.6 million gap after the biennial budget failed to account for cost increases. Meanwhile, the latest fiscal year 2018-19 budget, passed last year, required a $25.4 million boost just to keep the program on course, according to the department.

Last year, the department commissioned a study with an outside party, the Segal Co., to study options to resolve the problems; the Medicare Advantage program was one of the options recommended, the department said.

http://bit.ly/2LpIJME

Food Safety and Quality in Home Food Delivery

Food suppliers have to take a relook at their strategy if they have to gain a reputation in the market as providers of hygiene.

Among the many conveniences that technology has ushered into our lives is the facility of ordering food online and eating whenever we want to, instead of having to necessarily visit hotels or restaurants. Coupled with another recent phenomenon that has changed our lives forever-globalization-the home delivery market is growing at a terrific rate. It is pegged at between $45 and $50 billion annually, and is expected to grow at a rate of more than 50% by 2022.

This huge industry, part of the wider and bigger food supply chain industry, which involves many players and activities in meeting its demand; is often characterized by ignorance about the most vital aspect of food: hygiene. This is an industry, like say, healthcare, whose efficiency depends more on the last mile provider, than on planners and high-level managers and strategists. It is this foot soldier on whom the industry actually runs, in a sense. Yet, the home food delivery market is characterized by a shocking lack of knowledge about food hygiene on the part of these delivery personnel. If this is the story of a hygiene-obsessed country such as the US; one can imagine how appalling the situation must be globally.

food chain

One can attribute a twofold reason for this situation: the diverse and fragmented nature of the food delivery business, and the near total absence of regulation in it. It is thus an irony of the food delivery business that while the business continues to grow in terms of attractive numbers; the core aspect of food delivery, cleanliness, continues to suffer.

Regulatory controls lack teeth

Many consequences result from the lack of hygiene standards. Lack of hygiene affects products of daily use, such as poultry products, meat and other related foods. Consumers, most of whom are in the productive age group, fall sick often. When this happens, the economy’s productivity levels drop. Plus, it puts a heavy burden on the already overstretched healthcare sector.

There is the existence of a law on food safety: the FDA’s Food Safety Modernization Act (FSMA), which has rules relating to areas of the food supply chain such as distribution from the point of produce, documentation -especially for imported and exportable items- and supply chains. This fact notwithstanding, the FSMA is not potent or comprehensive enough to ensure hygiene at the critical source at which food is most vulnerable: the last mile supplier, or the food delivery point.

Get to understand the elements of food delivery hygiene

Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering a course in which the core areas of safety and sanitation aspects of home food delivery will be explained. Dr. John Ryan, a highly acclaimed expert on food safety, will be the speaker at this very high value webinar. Dr. Ryan is the Founder of John Ryan Systems, which he founded after gaining expertise in all the areas of the food safety industry for three decades, during which he worked in sectors such as manufacturing, food, transportation and Internet industries.

Please log on to http://bit.ly/2HxZTdK to enroll for this webinar and to gain insights into Dr. Ryan’s vast knowledge of the food supply industry.

Understanding the reasons for which food gets harmed

The ambit of this webinar is an explanation of the vulnerabilities that food in the food home delivery industry is exposed to. Dr. Ryan will explain the regulations that need to be complied with to ensure the safety of food, as well as the consequences of lack of compliance. Complying with regulations apart, food suppliers have to be more knowledgeable about how activities on their part can prevent disease outbreaks. Food suppliers have to take a relook at their strategy if they have to gain a reputation in the market as providers of hygiene. This is one of the major discussions of this webinar.

Dr. Ryan will explain how food supply companies that seek to get away from the reach of the law by deceptive and escapist recourses such as disclaimers can be hauled up.

food

At this webinar, Dr. Ryan will cover the following areas:

  • The issues of food safety and quality
  • Basic food sanitation and temperature controls
  • Appropriate dunnage
  • Evolving home food delivery Technology
  • Types of foods in the home food delivery market
  • Ordering models
  • Recall requirements
  • Integrated Online Ordering Companies
  • Call in or online orders
  • Some of the industry players.

How can a Culture of Quality and Compliance Impact your Company’s Success?

At this very important learning session on Quality, Suzanne will cover all the perspectives of Quality.

If there is one attribute that sits at the very core of an organization, it has to be Quality. If Quality is this critical to organizations; then, what is Quality in the context of an organization?  If Philip Crosby defined Quality as conformance to requirements and Sam Walton considered it as being able to give the customers what they want; William A. Foster explained Quality in an organization in the following words: “Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution. It represents the wise choice of many alternatives”.

Those in charge of Quality in organizations have to consider many questions relating to it. These are some of them: do we consider it an attribute or characteristic in relation to a certain standard or customer requirement? Is it all about achieving a state where our product is free from defects? Is it a system that we create for holding inspection standards or making the Quality System accountable to? Or is there something beyond all these?

Quality should become part of the organization’s culture

If there is one truly critical work that an organization has to carry out to become successful and to stay ahead; it is to imbibe Quality into its very core. Going beyond the semantics; Quality should become a way of life for the organization. it should become a philosophy, an inalienable part of its culture, and a habit. For organizations to meet and exceed customer expectations all the time and every time, Quality has to be implanted into the very essence of an organization.

Compliance4All, a well-known provider of professional trainings for the areas of regulatory compliance, explain all the elements of Quality at a webinar that it is organizing. Susanne Manz, a highly regarded leader in the medical device industry, who emphasizes Quality, compliance, and Six Sigma, and who brings extensive background in Quality and compliance for medical devices from new product development, to operations, to post-market activities, will be the speaker at this webinar.

Please register for this webinar by visiting http://bit.ly/2Hs2QMI

Quality from all perspectives

At this very important learning session on Quality, Suzanne will cover all the perspectives of Quality. Among the important learning objectives of this session is to teach participants to identify the warning signals that indicate that there could be Quality issues within the organization and the risks the organization faces from Quality and compliance issues. Participants will understand the ways of changing their organizations from being reactive to becoming proactive. Participants will understand how a culture of Quality and compliance can impact their organization’s success, and will learn the ways of creating a culture of Quality and compliance at all levels in their organization.

Suzanne will cover the following areas at this webinar:

  • FDA and NB expectations for Quality Systems
  • Lessons Learned from 483s and warning letters
  • How culture can impact Quality and compliance risk
  • Management commitment and responsibility
  • Maturity Modeling
  • Key capabilities
  • Roles and responsibilities
  • Quality planning and strategy
  • Tools and techniques
  • Best Practices.

How to survive an FDA Audit

FDA audit is to understand the factors that prompt an inspection of research.

Surviving an FDA audit is like trial by fire for many organizations. Even the most meticulous organizations have the potential for being nitpicked by the FDA for the smallest noncompliance.

The FDA has devised the Bioresearch Monitoring Program, or BIMO, an on-site inspections and data audit programs, designed to monitor all aspects of the conduct and reporting of FDA-regulated research.

howToSurviveAnFdaAudit

How to survive an FDA audit largely depends on how well the organization implements the requirements of the BIMO. BIMO is quite comprehensive, as it monitors Sponsors or Contract Research Organizations (CROs)/Monitors, the Institutional Review Boards (IRBs), Clinical Investigators (CIs) and nonclinical laboratories.

BIMO Program Objectives

Basically, surviving an FDA audit is dependent on how well it understands and implements the provisions of BIMO. The core objectives of the BIMO Program are:

  • Protect the safety, rights, and welfare of human research subjects; and
  • Assuring the integrity, reliability and quality of data collected.

The BIMO’s functions

If organizations have to survive an FDA audit; they need to understand the BIMO Program’s functions:

  • Auditing clinical data
  • Inspecting ongoing clinical research
  • Inspecting nonclinical laboratories and IRBs
  • Educating, training, and implementing FDA’s Application Integrity Policy.

close up of scientists making test in lab

Understanding factors that trigger an inspection

Another key to surviving an FDA audit is to understand the factors that prompt an inspection of research. These could be any of all of these:

  • New product or indication
  • Any new technology
  • Complaints
  • History of non-compliance, and
  • Even routine surveillance.

So, any organization that has to survive an FDA audit has to be aware of the intricacies of this program. Following and implementing its requirements step-by-step acts as a checklist for ensuring that it stays compliant.