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Pharma industry fights in Europe over competition in world markets :-: Politics

Politics Brand-name drugmakers and the companies that make copycat versions of their medicines are split over a proposal that one side says could take a bite out of its revenue and the other says could foster jobs. The clash is over a waiver of a special type of intellectual property protection given to medicines developed by the companies who are the first to bring drugs to the market. This protection, the so-called supplementary protection certificate, can last up to five years. Allowing a waiver of the certificate for manufacturing purposes would give generic drugmakers the chance to compete head-to-head with the drugs they mimic, at least in countries outside of the EU. The disagreement has reached flashpoint as both sides await a European Commission decision on the waiver before the end of the year. “This has been my No. 1 issue since I arrived at the association four years ago,” said Adrian van den Hoven, director general of the European generics lobby Medicines for Europe, which is working hard to see the waiver become reality. In Europe, branded drugmakers get a patent for 20 years when they discover a new drug. But this is just the beginning of their work. The Commission says its underlying goal is to boost manufacturing and jobs in the EU and inject competition into select industries, as it outlined in its October 2015 plan to upgrade the EU’s single market. The manufacturing waiver was proposed as a chief possibility because “it could allow the European generic … medicines industries to create thousands of high-tech jobs in the EU and many new companies,” the Commission said. The certificates are essentially an extension of branded drugmakers’ patents. In Europe, branded drugmakers get a patent for 20 years when they discover a new drug. But this is just the beginning of their work. They still have to test whether a drug is safe and effective for treating specific diseases. Once all of that is figured out, the company applies to the European Medicines Agency for approval to sell the drug. These testing and application processes can take up to a decade. That leaves drugmakers with about 10 years to recoup their investment in the drug. So the EU introduced supplementary protection certificates of up to five years to give branded drugmakers as long as 15 years to make their money back, and some profit on top of that, from the drug they developed. During this timespan, generics manufacturers can’t produce a copy of the branded drugmaker’s medicine within the EU. They can only produce their versions outside EU borders, where the supplementary protection certificate holds no sway. Generic drug store at the Victoria Hospital in Bangalore, India | Manjunath Kiran/AFP via GettyImages The waiver the Commission is considering would allow generic drugmakers to manufacture those protected drugs in the EU during the time covered by the supplementary protection certificate, though they could still only be sold to countries outside the bloc. That means copies of medicines to treat diseases like cancer, psoriasis and HIV could be produced in the EU and exported, according to van den Hoven. A win-win? Medicines for Europe argues this is a win for them and for Europe: Producing drugs on EU soil would generate jobs and revenue and allow them to better compete with huge generics manufacturing countries such as India and China, where similar protections for name-brand pharmaceuticals don’t exist. A study published in 2014 in the Journal of Generic Medicines calculates the benefit of the manufacturing waiver at almost 9,000 new direct jobs generated in Europe and some 35,560 new indirect jobs. The generics lobby also says the waiver wouldn’t harm brand name drug companies in Europe. Drugmakers investing in the research and development that yields the drugs that generics producers mimic beg to differ. Their lobby group, the European Federation of Pharmaceutical Industries and Associations (EFPIA), worries about the impact of competition from European-made generics in non-EU countries where the protection certificates don’t apply. So-called originator companies already have to compete with generics manufactured outside the EU. If generics made in Europe fare better on the market that those made in India or China, patients could end up buying the cheaper versions instead of brand-named drugs. “There are potential export losses to European originator companies resulting in a drop in export value for the EU,” EFPIA said. A loss in exports to world markets could result in job losses for branded drugmakers on the Continent, according to a report by QuintilesIMS commissioned by EFPIA. And the lobby group says its member companies would have a hard time ensuring that generics produced in Europe through the manufacturing waiver end up only in the countries where EU protection doesn’t apply. As a result the waiver would “have a significant impact on innovative, originator companies both in the EU and in export markets, for example with regard to the complexity and the costs required to monitor and enforce the policy,” it said. EU trade policy argues against using intellectual property rules to favor domestic production of medicines, but the introduction of the manufacturing waiver would see it do just that, according to EFPIA. A European Commission official who was not authorized to speak on the record said EU trade policy generally doesn’t support measures that discriminate between EU and domestic producers of any kind, but current EU rules give a competitive advantage to foreign generic companies over EU-based producers. “Improving a level-playing field would certainly not contradict in any way the EU trade-related intellectual property rights policies,” the official said. Manufacturing plant of generic drug producer Teva Pharmaceuticals | Uriel Sinai/Getty Images EFPIA points to a study published in January, also in the Journal of Generic Medicines, that disputes the 2014 study. It says the number of jobs created in Europe by the waiver would be much smaller: roughly 2,000 direct jobs, and some 6,642 indirect jobs. Waiting for the Commission Generics industry lobby Medicines for Europe is not giving up. The industry association fought back with a list of “myths to be dispelled” about the manufacturing waiver. It counters that original drugmakers already face competition in third countries where the protection certificate doesn’t apply. It’s just not from European-made generics, but from medicines produced in countries like China and India, or even the U.S., where the protection can expire earlier than that granted by the EU. “The SPC manufacturing waiver intends to allow European producers to compete on a level playing field with non-EU competitors,” Medicines for Europe said. Preventing exports of high-quality generic and biosimilar medicines to third countries also gets in the way of giving the broadest group of people real access to medicines, the generics lobby says, arguing poor countries cannot afford brand-name versions of the medicines because of their high prices. In the EU, the Commission generally supports the use of lower-cost generic medicines when they are available, to ensure national health systems spend money efficiently. And enforcement of intellectual property rights would not change with the waiver, in Europe or abroad — generic drugs couldn’t sneak into markets where the name brand drugmakers are protected, Medicines for Europe said. “The more we delay, the more very big molecules come off patent, and the production is outsourced to Asia” — Adrian van den Hoven, director general of Medicines for Europe Both sides are now waiting to see what the Commission decides to do next. Introducing the manufacturing waiver is among the primary changes the Commission is considering to legislation governing the protection certificates, according to a plan published in February. Other options include modernizing the EU law regulating the certificates and creating one that would apply across the bloc, rather than nationally, as is the case now. An EU-wide certificate would be beneficial to branded drugmakers because they wouldn’t have to apply for the protection from 28 different national patent offices. A Commission analysis looking at the pros and cons of all these options is supposed to be completed by the end of the year. That timeline may be ambitious, given that a public consultation linked to it hasn’t yet started. Generics lobby boss van den Hoven said he would like the Commission to introduce a legislative procedure targeting only the manufacturing waiver rather than packaging it with other legislative changes that could drag the process. “The more we delay, the more very big molecules come off patent,” he said, “and the production is outsourced to Asia.” This is part of a special report on the future of pharma incentives. Original Article

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Is Divorce Hereditary? Here’s How Your Genes May Be Partially to Blame :-: Health Magazine

Adult children of divorced parents are more likely to get divorced themselves, compared to those who grew up in two-parent homes, research has shown. Now, a forthcoming study in Psychological Science suggests that the reason may have more to do with nature than with nurture. In other words, an increased risk for divorce may be coded in our genes. To determine whether genetic factors play a role in couples’ likelihood of divorce, researchers in the United States and Sweden analyzed population data from nearly 20,000 Swedish adults who’d been adopted as children. They found that the adoptees were more likely to resemble their biological parents and siblings when it came to their histories of divorce, not their adoptive ones. RELATED: 12 Ways Your Relationship Can Hurt Your Health This was surprising, says first author Jessica Salvatore, PhD, assistant professor of psychology at Virginia Commonwealth University—since it goes against commonly held beliefs that divorce runs in families because children watch and learn from their parents and grow up to mimic their behavior. “A lot of the scientific evidence to date has suggested that seeing your parents go through a divorce contributes to your own propensity to experience divorce yourself,” says Salvatore. “But those studies haven’t controlled for the fact that those parents are also contributing genes to their children. By looking at adopted children, we’re able to separate out the genetic factors and the environmental ones.” Salvatore says the newly discovered hereditary connection is likely due to personality factors that have also been linked to genetics—like neuroticism and impulsiveness. “We know from other studies that these are factors that contribute to divorce,” she says. “They may make it more difficult for someone to stay in a relationship, or for someone to want to stay in a relationship with them.” RELATED: 10 Things You Should Never Do When You're Angry But Salvatore wants to emphasize that just because divorce appears to have has a genetic component, it doesn’t mean that people whose parents split up are destined to do the same. “This is absolutely not a perfect predictor,” she says. “It’s simply an increased risk, just as if you had a parent with an alcohol-use disorder, you’d also be at increased risk for developing one yourself." The environment you were raised in still matters, too, she says. In fact, the study also looked at data from more than 80,000 adults who’d been raised by a biological mother and a stepfather. In that sample, the researchers did find correlations between participants’ divorce rates and the divorce rates of their biological fathers, with whom they did not live. But their mothers’ marital history (with their stepfathers) was an even stronger predictor of their own marital success—providing some evidence that childhood environments affected future divorce risk “above and beyond” genetic influences alone, the authors wrote. Salvatore hopes her research can help people better understand the many factors that may put couples at risk for divorce. “We all bring liabilities into our relationships, whether we come from a happy, harmonious home or a troubled and fractured home,” she says. “And knowing how those liabilities work may help people reflect on and improve their own behavior in relationships.” It may also help guide therapists and counselors in making recommendations for couples who are struggling, she adds. “Other research has suggested that children of divorced parents lack commitment to their relationship,” she says. “But our findings really suggest that it may have more to do with certain personality factors, and that we may have to take a different approach in working with them.” To get our best relationship tips delivered to you inbox, sign up for the Healthy Living newsletter Neurotic people, for example, tend to interpret their partners’ behavior more negatively than objective observers do, says Salvatore. “If a clinician knows this is happening, he or she can help reframe—through cognitive behavioral therapy—that person’s perception of events in their relationship,” she says. “It can take the edge off of their interactions, so they're less hostile and give their partner the benefit of the doubt.” Because the study looked at Swedish individuals, Salvatore can’t say for sure that the findings would translate to an American population. There are a lot of similarities between the two cultures, she says, but also some significant differences. The average age at marriage is higher in Sweden, for example, and the divorce rate is higher. Let's block ads! (Why?) Original Article

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Most Divorces Happen in These Two Months :-: Health Magazine

Holidays and summer vacations seem to affect when couples break up, researchers say. More divorces happen in March and August than in any other months, according to a new study from the University of Washington. The research is believed to be the first to find evidence of a seasonal pattern of marriage breakups, and suggests that family rituals around winter holidays and summer may be driving the trend. Associate sociology professor Julie Brines, PhD, and doctoral candidate Brian Serafini didn’t set out to look for seasonality in divorce rates; they initially wanted to study the effects of the recession on marital stability. But when they began analyzing divorce filings in Washington State between 2001 and 2015, they were surprised to see a consistent pattern emerge. "It was very robust from year to year, and very robust across counties," Brines said in a press release. The spikes remained even after they accounted for things like unemployment and the housing market, which also tend to follow seasonal patterns. The researchers speculate that couples avoid filing for divorce around Christmas and New Year’s, as well as when school is out for the summer, because these times are considered sacred to families. "Family life is governed by a ‘social clock,'" they write, "that mandates the observation of birthdays, holidays, or other special transitions involving family members over the course of a year." RELATED: 7 Life Events That Can Lead to Divorce Filing for divorce during these special periods may be socially unacceptable to many couples, they say. And some unhappy husbands and wives may even think that spending a happy holiday or a nice family vacation together will help heal their troubled marriages. "People tend to face the holidays with rising expectations, despite what disappointments they might have had in years past," Brines said. "They represent periods in the year when there's the anticipation or the opportunity for a new beginning, a new start, something different, a transition into a new period of life.” Unfortunately, she adds, holidays often don’t live up to those expectations. In fact, they can be so stressful and emotionally charged that, for some failing marriages, they may be the last straw—what she and other sociologists refer to as a “broken promises” scenario. Brines suspects that couples need a few months to secure lawyers, get finances in order, and to work up the courage to file for divorce, hence the gap between New Year’s and the first noted spike in March. The same logic may apply in the summer after a month or two of family leisure time, she says, although the start of the school year could speed up the timing for couples with children and account for the second spike in August. RELATED: 10 Ways to Improve Your Relationship Instantly She also notes that suicides tend to peak in the spring, as well, and that some experts say that longer days and increased activity can elevate mood in people with depression enough for them to act on their suicidal thoughts. It’s possible, she says, that similar factors could motivate fed up couples to take action, too. The researchers presented their research as a working paper this weekend at the annual meeting of the American Sociological Association, and are now studying other states to see if their findings hold true in a larger sample size. So far, they’ve looked at Ohio, Minnesota, Florida, and Arizona. And despite differences in demographics and economic conditions in those states, they say, the seasonal divorce pattern “is more or less the same.” Let's block ads! (Why?) Original Article

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Common Exercise Therapy May Not Help Women With Leaky Bladder :-: Health Magazine

MONDAY, Oct. 16, 2017 (HealthDay News) — A commonly promoted exercise purported to help a woman control a leaky bladder probably isn't effective, experts say. The workout — called the abdominal hypopressive technique — (AHT) is a breathing and "posture-correcting" approach widely known and used in North America, South America and Europe, said a team of European researchers. With AHT, patients breathe in deeply through the diaphragm, contract the abdominal muscles after fully breathing out, and hold their breath before relaxing. But the new review of available research on the technique yielded no proof that it helps urinary incontinence, researchers reported online Oct. 16 in the British Journal of Sports Medicine. Even though there's "a worldwide huge interest" in AHT among women, "at present, there is no scientific evidence to recommend its use to patients," said Kari Bo, of the Norwegian School of Sport Science in Oslo, and Saul Martin-Rodrguez, from the College of Physical Education in Las Palmas de Gran Canaria, Spain. "To date, AHT lacks scientific evidence to support its benefits," the two experts concluded. "At this stage, AHT is based on a theory with 20 years of clinical practice." Bo and Martin-Rodriguez noted that AHT is just one of several breathing and posture-correcting methods that claim to prevent or treat leaky bladder and womb prolapse. Others include Pilates and tai chi. Dr. Elizabeth Kavaler is a urologist at Lenox Hill Hospital in New York City. She reviewed the data, and believes there are methods that can help with conditions such as prolapse and urinary incontinence. "Although AHT may not help with preventing prolapse and incontinence, pelvic floor muscle exercises and Kegels do," she said. "There is a body of literature that supports the teaching of Kegels postpartum to women in an effort to prevent prolapse and stress urinary incontinence." Kegel exercises consist of repeatedly contracting the pelvic floor muscles, as if holding back urinating, then relaxing them again. As well, Kavaler said, "diet, weight control, exercise and Kegel exercises are the best way to avoid needing surgery to treat these conditions." Dr. Farzeen Firoozi directs female pelvic health at Northwell Health's Arthur Smith Institute for Urology in New Hyde Park, N.Y. He agreed that the evidence just isn't there to support the effectiveness of AHT, but a technique known as pelvic floor muscle training (PFMT) may help. In PFMT, women work to strengthen certain pelvic muscles. "PFMT remains the standard technique for approaching the treatment of pelvic floor disorders from a physical therapy standpoint," he said. More information The U.S. National Institute of Diabetes and Digestive and Kidney Diseases has more on urinary incontinence in women. Let's block ads! (Why?) Original Article

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