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The Pharmaceutical Industry and Us

The Pharmaceutical Industry and Us. Kevan Wind Medicines Procurement Pharmacist London and East of England. Questions What is the time limit imposed on companies with branded medicines? What is PPRS? What is the most effective way of selling (anything)

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The Pharmaceutical Industry and Us

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  1. The Pharmaceutical Industry and Us Kevan Wind Medicines Procurement Pharmacist London and East of England

  2. Questions • What is the time limit imposed on companies with branded medicines? • What is PPRS? • What is the most effective way of selling (anything) • Why is the government split about how to manage the pharmaceutical industry? • Are patient groups independent? • What is the ABPI Code of Practice? • What is key about the Bribery Act?

  3. The Pharmaceutical Industry and Us By the end of this session you will be able to • Demonstrate an understanding of how the Pharmaceutical Industry functions • Identify techniques used by the Pharmaceutical Industry to influence prescribing • Demonstrate awareness of the ABPI and the code of practice • Know how to report poor practice from representatives of the Pharmaceutical Industry • Demonstrate awareness of the influence of the Pharmaceutical Industry on policy making. • Demonstrate understanding of how NHS trusts manage the influence of the Pharmaceutical Industry

  4. The Pharmaceutical Industry and Us Subjects Covered • How Industry Functions • Techniques they use to gain influence • The ABPI and their Code of Practice • Government and NHS Actions

  5. The Pharmaceutical Industry and Us 1. How Industry Functions So What is the Function of Industry? What They Say GSK “Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer” Pfizer “Our Mission We will become the worlds most valued company to patients. Customers, colleagues, investors, business partners, and the communities where we work and live. Our Purpose We dedicate ourselves to humanity’s quest for longer, healthier, happier lives through innovation in pharmaceuticals, consumer and animal health products”.

  6. The Pharmaceutical Industry and Us However Like all companies they need to make a profit for their shareholders (most are public companies and you own shares in them). In a survey carried out in the US they came out lower than tobacco companies when asked to rate their ethics. This may be a little unfair. In my view they are no better or worse than other big industry • You must recognise their drivers • You can work with them • What would you do in their place?

  7. The Pharmaceutical Industry and Us Remember They are on a treadmill going faster and faster It costs more and more to develop new medicines and they have a limited time to recoup that money before patent expiry. (interestingly all the big companies are now investing in generic manufacturing) Name of the Game • Develop products with as big a market as possible (NB Orphan products) • Get as long a patent as possible (NB process patents and cis isomers) • Maximise profits within PPRS

  8. The Pharmaceutical Industry and Us NB PPRS What is it? (Pharmaceutical Price Regulation Scheme) Limited (or guaranteed) level of profit for the industry • Is dependent on investment in UK • Can be spread across product range as they desire • Prices freely set (but profit capped). Once initially set though are fixed. • If they make more it goes back to government (not NHS) • Is an allowance for promotion. • Highly complex in detail • Gives stability of pricing BUT not pricing control • OFT suggesting prices set according to drug benefit. • Also UK a reference site for other countries pricing. (So now have Patient Access Schemes [Risk Share]).

  9. The Pharmaceutical Industry and Us 2. Techniques Some are described here. NB Healthcare Select Committee Report 2005. Influence of pharmaceutical industry:- “It is widely welcomed and relied on, but it is also pervasive and persistent. Our over-riding concerns are about the volume, extent and intensity of the industry’s influence, not only on clinical medicine and research but also on patients, regulators, the media, civil servants and politicians.” “The influence of the pharmaceutical industry is such that it dominates clinical practice”, “ self regulation is not at present effective. It could take on greater responsibility for regulation when its activities are fully transparent and effectively audited.” “The regulatory authority, which is responsible for controlling much of the behaviour of the industry has significant failings.” “ this inquiry left us in no doubt that the scope for conflict between health and trade interests is huge. We firmly believe that the Department and the MHRA should focus on health priorities”. Also invention of diseases etc.

  10. The Pharmaceutical Industry and Us 2. Techniques • Personal Selling • Enhance the image of the company • Increase the loyalty for company and products • Inform the customer about benefits of products • Sell to decision makers and influencers • Drug information source (passive) • Train/ teach about new products (reactive) • Collect market and competitor product information • Problem solve • Negotiate prices Role is decreasing as prescribing is more driven by policy. Now looking for agreements with organisations “partnerships”. Is some evidence that nurse prescribers are susceptible to personal selling and are being targeted by some companies. Beware of “trials” or samples. Some are a way of getting a new product into use and have little scientific benefit. Ladybird Book on Pharmaceutical Industry describes it well.

  11. The Pharmaceutical Industry and Us 2. Techniques b) Influence Gifts Hospitality etc. NB There will be guidance on what you can and cannot expect. ? College Nursing There is no such thing as a free meal. They will always want something. • Access (you may feel obliged to see them) • Information (on policies, people to influence, data, prices) • Your actions (changing prescribing habits etc.) • Your time. As a way to bend your ear. • Access to markets (e.g. enteral feeds, diabetic testing) My advice have rules. Mine new rep new drug new deal AND by appointment Yours? What should they be? Do you need to see them at all? Reviews from MI are better and independent.

  12. The Pharmaceutical Industry and Us 2. Techniques c) Influence on Policy As more prescribing is policy lead is an increasing need to influence this. Moving from “cannon fodder” to “ smart bombs”. I.e. Old = loads of visits new = targeted activity Beware a man offering “partnerships” Can be mutually beneficial (e.g. SKB and Southend ) What is in it for them and what are they gaining?

  13. The Pharmaceutical Industry and Us 2. Techniques d) Influence on Government Policy • Difference between New Zealand and UK • Pharma contributed £2.8 billion in trade surplus in 2013 • Third biggest contributing sector in UK • Employed 73,000 people in 2011 • “World Class and a Jewel in the Crown of the UK Economy”Healthcare Select Committee report 2005. Therefore important (very). Regularly get “threats” to pull out of UK. Government and ABPI joint statements.

  14. The Pharmaceutical Industry and Us 2. Techniques And if nice doesn’t work………………. e) Legal Action • Scare tactic • Delaying tactic (patents) • Blocking tactic (e.g. PI’s) • Perhaps Genuine CMU as target (e.g. Clozapine & Novartis, Igg and Baxters).

  15. The Pharmaceutical Industry and Us 2. Techniques f) Sponsorship of Patient Groups • Some of the more covert behaviour mentioned in the select committee. • Many patient groups heavily supported by industry. • Think carefully about what they say. g) Clinical Trials • Some research commercially motivated. • Some research unpublished. • Lots research not done (e.g. comparator trials).

  16. The Pharmaceutical Industry and Us 2. Techniques h) Press • Lots stories fed to press (e.g. launch Seretide) • Counterfeit medicines. • Product Releases and Withdrawals • Cis isomers (Esomeprazole) • SR preparations (Tamsulosin) • Tabs and Caps (Omeprazole) • Withdrawal of form (Dovonex) • Withdrawal of strength (Doxazocin)

  17. The Pharmaceutical Industry and Us 3. ABPI Code of Practice Available on www.abpi.org.uk/links/assoc/PMCPA/pmcpa_code2006.pdf Covers all promotional material which should be “Responsible Ethical and Professional (REP). • All reps trained in it • Operates as a complaints system • Health professionals should not be subject to unacceptable sales techniques • Limits on samples • Limits on gifts (£6.00). • Limits on advertising, promotional and printed material

  18. The Pharmaceutical Industry and Us 3. ABPI Code of Practice Is enforced (e.g. Abbott and Lap Dancers) but ? sanctions (suspended). How to report • Unacceptable behaviour complain to rep • Complain to area manager • Report to ABPI

  19. The Pharmaceutical Industry and Us • Government Actions to “control” market Government “Schizophrenia” • £2.8 billion trade surplus • 73,000 jobs • BUT £14.4 billion drugs bill (5.8 billion in secondary care) (2014)up by 7.6% (15.8% in secondary care). Acts a series of hurdles before a medicine is used. NB ABPI state UK slow at medicines uptake (so must be working) NB How many medicines are such a huge benefit you MUST have them (and how many have been withdrawn due to unforeseen problems)

  20. The Pharmaceutical Industry and Us National Initiatives • Medicines Act 1968Licensed medicines only (NB specials) (now under review) • PPRS • NICE (PASLU) • OFT PPRS Recommendationson value pricing • Commissioning (NHS England prescribing policies and CRGs).

  21. The Pharmaceutical Industry and Us 4. Government Response Local • Formularies • MI (DURs, New Drugs Groups) • Prescribing Initiatives (e.g. SHA Statin initiative). • Indicative Budgets • SHA / PCT Advisers • Training for new prescribers. (we are a government initiative!)

  22. Bribery Act Became law recently. Now organisation is liable if an employee is bribed (for not taking preventative action) So all organisations now have bribery policies and you can be dismissed for not following them. What is yours?

  23. The Pharmaceutical Industry and Us Summary • Industry very powerful despite the constraints upon it • We have responsibility to use medicines SAFELY EFFICACIOUSLY COST EFFECTIVELY Be very careful in your dealings with industry. They don’t do anything for nothing • Why are they doing what they are doing? • What is the NHS getting out of this? (as opposed to you). • What is the real cost? • What is the industry gaining?

  24. So……………… What Are the Key Take Home Messages from this session? I think they are these • The industry influences all of us…… no one is immune. • Personal Selling is the most effective technique of all. • What reps want is • Access • Information • To change your actions • Time • So you need rules to help you manage them • The ABPI Code of Practice can help you.

  25. Questions • What is the time limit imposed on companies with branded medicines? • What is PPRS? • What is the most effective way of selling (anything) • Why is the government split about how to manage the pharmaceutical industry? • Are patient groups independent? • What is the ABPI Code of Practice? • What is key about the Bribery Act?

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