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Marketing Authorisation - Medicinal Products
Marketing Authorisation: Medicinal Products The case of R (on the application of Merck Sharp and Dohme Ltd) v Licensing Authority [2005], concerned the application for marketing authorisation for a generic product which was based on Product C (see below). The claimant had marketing authorisations for three medicinal products used in the treatment of osteoporosis and three generic companies sought marketing authorisation for Product C. Product A - was authorised by the European Community in 1993; Product B - was authorised in 2000 Product C - was a generic product based on Product B (a copy of Product B). When a company applies for marketing authorisation for a product, it is a requirement under the European Parliament and Council Directive (EC) 2001/83 (the "Directive"), to supply a full set of data in order to show the safety and efficacy of the product. There are instances under the Directive when an applicant can simply rely on data submitted in respect of a previously authorised product. For instance, the applicant could refer to data already submitted in respect of a product with marketing authorisation, where the applicant is seeking authorisation for a product 'essentially similar' to a product holding a marketing authorisation for ten years (as per the United Kingdom and pursuant to art 10(i)(a)(iii) of the Directive). In seeking marketing authorisation for Product C, the generic companies relied on data submitted in relation to Product A and Product B. However, although Product A and Product B contained the same active ingredient, they were not 'essentially similar' within the meaning of the Directive. This meant that they differed in respect of their posology (the schedule of dosage). The defendant accepted that the generic companies did not have to provide any further data but the claimant argued that such an approach was unlawful and in breach of the Directive. The claimant made a reference to the European Court of Justice ("Court of Justice"). The claimant contended that the issue was as yet unresolved by the rules laid down in previous decisions of the ECJ. In particular, it was argued, that there had been no cases where a difference in posology had been the subject of a decision. The application was dismissed. The ECJ held that: The principles laid down by the ECJ in earlier decisions were clearly applicable in this case and there was no uncertainty; Although it was true that a change in posology had not previously been the subject of a decision, it was for the ECJ to interpret the EC Treaty and the relevant principles by which it was to be interpreted, and for the domestic court to apply those principles to the particular case. No new principles arose in the instant case. If you require further information contact us. Email: enquiries@rtcoopers.com © RT COOPERS, 2005. This Briefing Note does not provide a comprehensive or complete statement of the law relating to the issues discussed nor does it constitute legal advice. It is intended only to highlight general issues. Specialist legal advice should always be sought in relation to particular circumstances. Rosanna Cooper is a partner in RT Coopers Solicitors a full service law firm in London. The firm specialises in patents, trade marks, copyright, designs, technology transfer, biotechnology and pharmaceutical law. The firm has a flexible approach to fees and provides the highest quality legal advice. Contact us at enquiries@rtcoopers.com. visit our website at http://www.rtcoopers.com
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Alternative Medicine Over Medication; Grandma is on Drugs It is very interesting this hypochondriac attitude which permeates our society? The power of suggestion is alive and well? "Do not feel good today, take a drug?" Oh that made you feel a different way? Take another drug? Oh those two together caused another feeling you do not like, my oh my, here is a third drug? You know these tests prove conclusive that this is not working and something is wrong, we should try this other drug too? Crazy, are you buying all this. What You Should Know About Mixing Medications and Diet... I had a call the other day from a potential client in a serious situation. He was young and had been diagnosed with CAD (Coronary Artery Disease), suffering from extremely high blood pressure and cholesterol, his doctor had put him on a medication that was suppose to lower and control these symptoms, and he had been on this medication for over 2 years. First Responder Human Hibernation Units In the next few years paramedics, first responders and military medics will have instant hibernation devices. These devices will come in small canisters of the gas to slow the body down after replacing lost blood and/or stopping bleeding. The replacement blood will be synthetic and coagulate faster to seal the wounds and once this happens the victim of the injury will be given hibernation gas. This gas will put the person in temporary suspended animation. When multiple victims are around each person will be administered the hibernation gas as the available first responders work thru the victims in order of most injured and serious first. Watch Out for Misleading Pharmaceutical Advertising In 1997, the Food and Drug Administration relaxed the rules for drug advertising on television and radio. Since that time, the airwaves have been flooded with commercials for all sorts of drugs. Some of them are vague, with a simple "Ask your doctor if drug x is right for you"; others spell out what the drug is used for and devote the commercial to telling you how much you will appreciate your product. Most consumers will probably assume that these commercials are honest, that the drugs will do what the ads say they will do, and that there are no side effects other than those mentioned in the ad. That may not be true, and consumers should be aware that the ads may not tell the whole story, and that they may be misleading.The pharmaceutical industry spends $9 billion per year advertising their products, and the money they spend on television and radio ads is probably the most effective. Doctors may be skeptical of a product touted by a salesman, but consumers are easily swayed by television ads that show people living happy, productive lives while being treated for an ailment using the advertised product. Unfortunately, these ads may not be completely honest. In 2004, the FDA investigated thirty-six ads for drugs that the agency found to be misleading or incomplete in their descriptions of side effects. Consumers might think that the commercials must be honest, since the FDA wouldn't allow dishonest commercials to air. Unfortunately, that's not the case. The FDA does not require pharmaceutical companies to provide screening copies of their advertisements prior to airing. The FDA doesn't actually see the ads until the consumers do. Several months may pass before the FDA takes action. In the case of misleading advertising, the most the FDA can usually do is ask the companies to either stop running the ads or to change them. These requests aren't always timely, however. In the last five years, the FDA has asked the drug companies to stop running several ads that had already stopped running!What this means for consumers is that some doubt should be exercised while viewing a commercial for a new drug. If you think an advertised product may be useful to you, discuss it with your physician, but ask if they know of any problems associated with the product. Research the product on the Internet. When your health is at stake, a little caution may be a good idea. Dr. Will Horsley, M.D. Dr. Horsley is Cornea fellowship trained and Lasik board certified by the American Board of Eye Surgeons, (http://www.aces-abes.org) in addition to being Board Certified by the American Board of Ophthalmology. Other refractive surgeries performed at the Horsley Eye Center are Conductive Keratoplasty, (to restore reading vision after 40), clear lens exchange, (for sever hyperopia), and the intra ocular contact lens or ICL for extremes of myopia untreatable by laser refractive procedures. Why Drug Companies are Naughty and 5 Remedies to Cure the Symptoms With the hum of the election campaign and the debate of "big business," versus human interest, I decided to do a bit of muckraking into the art and science of the recent removal of Merck's Vioxx. My motivation of course; to look for clues as to the role drug companies play in our health and wellness (or lack thereof). Lunesta Tolerance Lunesta is a newly released sleeping pill. Marketed as a revolutionary sleep aid, Lunesta is the only medication approved by the FDA for long term treatment of insomnia symptoms. Although Lunesta is a quality medicine that has already helped many people cure their insomnia and get a better night's sleep, there is something you should know before your buy Lunesta. Is Anxiety Ruling Your Life? Anxiety is the most frequently occurring mental health disorder in the United States, according to the US Surgeon General. There are millions of people who are diagnosed with it every year. A small amount of anxiety helps to get us going, but when it becomes more severe, it can be overwhelming. If you start feeling like it's more than it should be, you may want to visit a doctor for a clinical diagnosis. The National Institute of Mental Health (NIMH) has estimated that 19 million Americans aged 18 to 54 suffer from anxiety disorder every year. The Pain Factor Last year I told an acquaintance that at the age of 46, I had taken up running. The reply was, "Oh, that's awfully hard on your knees." At first I was taken aback. Yes, I knew if I did not stretch, warm-up or wear properly fitted shoes, I might experience pain or an injury. But the person telling me this was overweight, had borderline high blood pressure, and never worked out. I wondered if this friend realized by living a sedentary lifestyle, the odds of developing heart disease, osteoporosis, diabetes and some cancers had substantially increased. Not to mention that being overweight actually placed this person at a higher risk than me for developing knee pain from osteoarthritis and heel pain as a result of plantar fasciitis. Propulsid Litigation Lawyer Says: Unnecessary Drug Killed 80 People Propulsid was a popular nighttime heartburn drug before it was pulled in the market in March of 2000. It was linked to dozens of fatal heart rhythm abnormalities. A Food and Drug Administration (FDA) document associated the drug with 341 reports of heart rhythm abnormalities and 80 reported deaths. The FDA also acknowledges that only a small fraction of problems with a drug are ever reported. Mexico: Drugs Galore! You are going to find this incredible and I assure you I am not making any of this up: You can waltz into any pharmacy (Farmacia) in Mexico and buy almost anything without a prescription. Except for controlled substances, you can get most anything you want or need simply by asking. Paxil Recall Lawyer Discusses Paxil Addiction Paxil went on the market in 1992 at the height of antidepressant drug popularity. It is a member of the class of antidepressants called selective serotonin reuptake inhibitors, or SSRIs. The SSRI drugs revolutionized antidepressants because they have very few side effects and it is practically impossible to overdose on them. It makes sense not to prescribe a depressed person with pills they can easily overdose with. Though a latecomer to the SSRI market, Paxil grew successful very quickly by gaining FDA approval for very specific conditions like "social anxiety disorder" and "general anxiety disorder", which were very rare conditions at the time. In running add campaigns, Paxil encouraged people to try their drug if they'd experienced any general anxiety and, as can be expected, sales of Paxil soared. Ulcers Are No Laughing Matter Peptic ulcers, which are in the stomach and the duodenum (the first part of the intestine leading from the stomach) can occur at any age and affect both men and women. Untreated, sufferers can look forward to a long siege with them. But today's peptic ulcer sufferers have a brighter prospect for relief than did those of even a single generation ago. There is now less than 1 chance in 18 that surgery will every be necessary and new medications act faster and better and offer more relief than ever before. OxyContin Addiction: Doctors & Drug Lords OxyContin is a narcotic drug, an opiate, that has been approved by the FDA to legally treat chronic pain. Chronic pain is documented medical condition, a progressive disease of the nervous system and spine that causes constant a patient to experience constant, excruciating pain. Chronic pain is caused by the failure of the body's internal pain control systems and is accompanied by changes of the chemical and anatomical makeup of the spinal cord. Left untreated, the condition will spread to unaffected areas. A patient suffering from chronic pain does not produce enough natural opiates, so a pharmaceutical opiate like OxyContin is an effective treatment for the disease. The Right Stethoscope For Your Needs! Just about all health care providers have need of stethoscopes. Whether you are a nurse, respiratory therapist or a medical doctor, the need to auscultate the chest, lungs and heart is a necessary and important part of your work. In deciding from the many stethoscopes to choose from it's important to keep in mind what you'll be using your stethoscope for. For general purpose listening, stethoscopes are excellent tools and come at a very good price. Three Questions People Are Asking About Health Care in America Q. Why is there so may uninsured people in America? Causes and Types of Cerebral Palsy In the case of Cerebral Palsy there is no one cause of this severe condition. There are many things that may increase the risk of this condition but will not cause cerebral palsy all the time. In the majority of cases and average of seventy percent, it results from brain injury before the child is even born this is known as congenital cerebral palsy this would be present from birth but may take months even years to diagnose depending on how severe it illness is. There is also a chance of acquired cerebral palsy which could happen through there being a case of meningitis or brain injuries. Medical Malpractice Suits: Death By Medicine A recent report has found that Americans are more frightened of dying at the hands of their doctor than they are of a plane crash. The overwhelming majority of those who participated in the survey said that information about malpractice suits and medical errors would be the single most deciding factor in trusting a healthcare provider. These people must have heard that medical errors cause more deaths in the United States every year than car accidents, AIDS, or breast cancer. Eliminate Agonizing Hand Pain Quickly and Easily! According to Dr. Nathan Wei, "The hand and wrist are the mirrors of disease." While the cause of hand pain can be a localized problem, hand pain can also be the presenting sign for other diseases. Zyprexa Lawsuits Zyprexa is an antipsychotic medication that works by changing the actions of chemicals in the brain. Zyprexa is used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar disorder. Zyprexa may also be used for other purposes.
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