New drug encounter challenges and future trends
Medical network on December 15 - new drugs is not only the innovation medicine, but relative to the clinical application of existing products, in the efficacy, safety and cost of treatment in improving all aspects of the product.
New survival challenge
New product approval cycle is long, the market transformation is slow and difficult, cost investment, early operation to make ends meet, disordered cluster homogeneity product declaration, market access, cycle is long, disordered competition, greatly shorten the product life cycle, is the development of the domestic new drugs facing the common agonies. A good product after 10 years in the coming year "resistance" to reincarnation, 20 years of patent period had consumed products available for 12 years, transferred to the sales link waiting for health care and other market access and market need to 5 years, three years after the health care product sales has just entered the mature period, huge investment, long waiting period to become new drugs to survive winter snow and ice, can not bear, bear, stand can't being together.
In recent years, due to the late open, healthcare and netting a year only four, five provinces of the bid opening, this is a normal hospital record purchase (pick) be kept under strict control, drug marketing generally get into trouble. Countries to ensure that the drugs and commonly used medicines accounted for, in the a large number of cleaning products, has not yet started to handle new product even if lucky enough to catch up with the tender at their own expense, began the long wait for a moment into the courtyard. More troubling, some reform pilot area only for health care products, medicine and new farming directory products, in addition to the part of the innovation medicine products, other out-of-pocket products even hang a web directory is not enter directly. No. 70 document to prepare bid amount according to the previous year 80% product catalog and other products according to different directories directly classify hang nets, some local execution often are missing at the ethnic medicine, hospital in pin was more on sales and high amount of products, only increases the new survival crisis.
A new decade of research and development expenses amount to tens of millions of yuan, namely, coupled with GMP reformation, the eia, the market investment, etc., at the beginning of the product that has been put up little tens of millions, many prepaid cost one hundred million yuan, the national one-size-fits-all drug prices, ignoring the different life cycle, the different stages of product pricing rule, does not drop down, less mature products, new product together brush halved, secondary bargaining for new products, the innovation enterprise is a kind of suppression. More than 80% of the domestic r&d spending on new drugs, new drugs not dozens of new products, the improvement of existing products, quality, efficacy, safety, such as ratio of treatment greatly improve the good product should encourage and support the French drug levels and health can be guaranteed, the future will not encounter the preparation shortage, expensive and difficult.
Environment is becoming worse, more and more diseases, the incidence is higher and higher, to help people to get rid of the disease, to bounce back in addition to the doctors' medical skill, more need to suit the medicine to, expensive medical drugs, will be developing for medicine health care reform, will stifle new survival and development space, thereby causing loss to the enterprise investment, the state and the public health burden is getting heavier and heavier, drug marketing faces the lockout, face anything, new drug research and development, the development of the pharmaceutical industry woes.
Who is the lucky guy in the future?
New drug research and development costs and threshold, destiny will only become more and more high. Clinical trial data verification, consistency evaluation, inspection measures such as forced continuous upgrading of the real level of research and development of enterprises and the quality of our products and the specifications of the bigger the enterprise benefit. But only by increasing the threshold of funds and technical threshold is not enough, work input to the enterprise should also increase the guidance and support, to help enterprises to improve the standardization of the new product development to declare and success rate, a chance for more medicine to help patients to improve health. Tend to ten years, twenty years to grind out a great products, on the premise of ensuring safety, for the potential value of products in the exploration should be given the opportunity to encourage, guide and error correction, innovative support mechanism, is more conducive to product innovation. Also suggested that countries in the approval process in addition to the excessive repetition to declare the product list on a regular basis, continue to strengthen in view of the industry and enterprise project planning, dynamic guidance and early warning, and other functions of macro management, to better match the industry research and development of resources, avoid blind cluster enterprise project, a large number of homogeneity to declare.
Children have to taste a lot of good policies, can separate procurement directory to avoid hanging nets. Need to pay attention to is that a lot of product although there is no single dose packaging, only adult dose by half, the same high quality and low price, popular with clinical, should give the same living space, this kind of product to avoid the policy of hitting it out of the hospital, children special packaging instead of price is higher. Another problem is the product pricing, if with the same process just dose by half of adults no worse than, it is easy to become the next prices artificially high. Drug abuse children should also attach great importance to. The same is true of medicine of department of gynaecology.
Declare the green channel, national medical treatment of a serious illness insurance to implement new policies such as developed for some serious diseases such as cancer medicine drug innovation or imitation brought spring breeze, the tumor control and treatment cost effective control of side effects become the focus, deviate its shape and avoid policy implementation. Performances, medicine treatment also become market, research and development of hot object.
Slow disease drug use is also a piece of "cake", notable is that the current health care system for patients to use drugs, the most convenient time for decades long-term medication of the old and the sick, went to a chemist's shop to be obtained with a prescription to community hospitals have no medicine, the patient eventually forced back to the big hospital queue register, increase the burden and hospital patients. Commonly prescribed barrier-free retail transformation, give full play to its normal drugstore to avoid simple things complicated. As dosage form even similar drug merge, hanging nets product quantity control, will be a lot of homogeneity product, multi-channel sales related enterprises need to layout in advance, before the clinical with retail sales order to seamlessly.
Regarding adjuvant, both to avoid the abuse of past wild mowgli, also should avoid to stroke such drugs in the end, from one extreme to another extreme. Myocardial nutrition, vitamins, tumor radiation and chemotherapy and other auxiliary medicine still has a role in the adjuvant treatment of, protect the body, accelerate the cure. According to the illness and the patient condition to decide whether to use more scientific by patients. Impedance of highly centralized directory products use is also easy to increase the risk of drug resistance, still need to use more scientific and reasonable distribution.
How policy advantages to the disadvantages
Reform for new drugs of another shock and confusion is the integration of urban and rural areas, completely break the progressive laws, cause city residents have no good medicinal, complain a lot, advance rural residents use expensive drugs, new drugs, waste is great. How to be more reasonable netting cycle, avoid many years don't hire trapping yourself before and now recruit, year after year from year to year sports building, effective open hospital autonomy for the record the purchase, originally is the right to run the medical institution which return, respecting the rule of market, and improve the professional norms, strengthen supervision, more conducive to market prosperity and stability.
Policy guidance to medical development how to layout for the next ten years, is a xing is failure. How to create more market transformation conditions for new drug innovation, effectively reduce the burden of enterprises and cost, and help enterprises to speed up the sales transformation, realize the scale operation, can more effectively reduce prices, to achieve national, public, medical institutions and medical enterprise multi-win-win situation.
If new drugs because of the policy limit loss of living space, the pharmaceutical industry and people's health get busy can be dangerous in the future. The pharmaceutical industry, medical institutions can not stay alone. Also please respect the medicine for the national health service, for the national pharmaceutical industry development space. No medicine, hua tuo is alive and hesitation. Faced with the complicated disease, we good medicine is not too much, but too little.