{"id":4752,"date":"2012-06-26T07:21:04","date_gmt":"2012-06-26T07:21:04","guid":{"rendered":"https:\/\/gregorydamy.niceavocats.fr\/?p=4752"},"modified":"2023-08-03T09:52:37","modified_gmt":"2023-08-03T09:52:37","slug":"medicine-regulation","status":"publish","type":"post","link":"https:\/\/gregorydamy.niceavocats.fr\/en\/medicine-regulation\/","title":{"rendered":"Health scandals: how are drugs put on the market?"},"content":{"rendered":"

[et_pb_section fb_built=”1″ _builder_version=”4.19.5″ _module_preset=”default” global_colors_info=”{}”][et_pb_row column_structure=”1_3,1_3,1_3″ _builder_version=”4.19.5″ _module_preset=”default” background_enable_mask_style=”on” background_mask_style=”wave” background_mask_color=”rgba(0,0,0,0.08)” custom_padding=”||6px|||” locked=”off” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.19.5″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.19.5″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.19.5″ _module_preset=”default” global_colors_info=”{}”][et_pb_circle_counter title=”Estimated reading time (in minutes)” number=”1″ percent_sign=”off” _builder_version=”4.19.5″ _module_preset=”default” title_font=”Amiri||||||||” max_width=”137px” global_colors_info=”{}”][\/et_pb_circle_counter][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.19.5″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.19.5″ _module_preset=”default” global_colors_info=”{}”][et_pb_divider _builder_version=”4.19.5″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_divider][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.19.5″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.19.5″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/gregorydamy.niceavocats.fr\/wp-content\/uploads\/2023\/08\/headache-1540220_1280-2.jpg” title_text=”headache-1540220_1280-2″ _builder_version=”4.21.0″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″][\/et_pb_image][et_pb_text _builder_version=”4.21.0″ _module_preset=”default” text_font=”Amiri||||||||” global_colors_info=”{}”]<\/p>\n

The Mediator affair or more recently the D\u00e9pakine affair are, among other things, the biggest health scandals of the decade in France.\u00a0The late withdrawal from the market of these long-contested drugs would be the cause of hundreds of deaths or major disabilities in France\u2026 How could this have happened?\u00a0How are drugs controlled?<\/span><\/h2>\n

A drug only reaches the\u00a0<\/span>market<\/span><\/a>\u00a0after a long process of development and control.\u00a0The goal: to avoid accidents.\u00a0But beware of any inappropriate use…<\/span>
A drug is “a complex product which acts on the body, with an expected benefit, but also adverse effects, mild or serious, indicates Catherine Lasalle, director of scientific affairs at Leem, the organization which federates pharmaceutical companies.\u00a0All new medicines are tested and evaluated in terms of safety, quality and efficacy.\u00a0Clinical studies make it possible to detect the most frequent effects, to assess the benefit\/risk and the monitoring criteria for certain patient profiles.\u00a0\u00bb<\/span><\/p>\n

It all starts with preclinical studies, which involve animal testing.\u00a0Only then can clinical analyzes be carried out, by testing the new compound on humans.\u00a0This phase, which can last ten years, is done in several stages on groups of volunteers: a few tens or hundreds of people at the beginning, then several thousands or tens of thousands in the last phase.<\/span><\/p>\n

Placing a medicine on the market:<\/span><\/h2>\n

In fact, a large number of studies are carried out:<\/span><\/p>\n

\u2013 pharmacologically: to describe the behavior of the active ingredient in the living organism,<\/span>
\u2013 toxicologically: to define the doses not to be exceeded.<\/span>
The observations resulting from these studies are contained in the marketing authorization application file (AMM).<\/span>
Then, the drug agencies give their agreement on the known tolerance of the active ingredient and especially on the favorable benefit\/risk for the patient, adds Catherine Lassalle.\u00a0The drug continues to be monitored for five years, very carefully, by the same authorities.<\/span>
This observation may lead to precautions for use or restrictions.\u00a0The Marketing Authorization may be modified in its indication and extended if the drug proves effective for another disease.<\/span>
A course supposed to provide maximum guarantees, but which does not prevent accidents, due to inappropriate prescription or use.\u00a0Hence the importance of the pharmacovigilance system set up with health professionals to report any adverse effects.<\/span><\/p>\n

Lack of\u00a0<\/span>centralized monitoring<\/span><\/a><\/h2>\n

However, to date, no organization in France provides centralized monitoring of drugs on sale.<\/span>
The evaluation depends on two agencies:<\/span><\/p>\n

\u2013 the National Medicines Safety Agency (ANSM), a kind of medicines policeman, which manages pharmacovigilance;<\/span>
\u2013 the Haute Autorit\u00e9 de Sant\u00e9 (HAS), which assesses the therapeutic value of each drug currently on the market.<\/span>
The HAS Transparency Commission assesses the actual benefit (SMR) of the drug and its improvement when it is first marketed.<\/span>
Thereafter, the product is reassessed every five years, unless a decrease in the benefit\/risk ratio is suspected in the light of new facts, in particular an increase in alerts reporting problems (cardiac, for example).<\/span>
For example, 3rd generation pills have been re-evaluated twice.\u00a0In 2007 a second line prescription was requested and in 2012 a delisting was advised.\u00a0Similarly, anti-Alzheimer’s drugs that showed marginal efficacy and definite toxicity were downgraded to low SMR.<\/span>
The HAS also establishes “recommendations for good use”, to guide the prescription of doctors.\u00a0These indications appear on the HAS website, but doctors still need to know them.<\/span>
In the same way, medical visitors must disseminate the opinions of the Transparency Commission.\u00a0Do they?\u00a0We can doubt it.<\/span>
It should be noted that since April 25, 2013, a European list of medicines under enhanced surveillance has been published each month by the European Medicines Agency (EMA).<\/span><\/p>\n

The life cycle of a drug<\/span><\/p>\n

\u2013 Patent filing<\/span>
\u2013 Preclinical development: in vitro and in vivo evaluation of the molecule’s activity in animals.<\/span>
\u2013 Preclinical and clinical trials: 8 to 10 years<\/span>
\u2013 Phase 1: Drug tolerance in the body.<\/span>
\u2013 Phase 2: Determination of the optimal effective dose.<\/span>
\u2013 Phase 3: Assessment of the benefit\/risk ratio.<\/span>
\u2013 Production and authorization: 1 to 3 years.\u00a0MA is issued by the National Medicines Safety Agency.\u00a0Determination of actual benefit (SMR).<\/span>
\u2013 Shelf life of the drug: 20 years.\u00a0The SMR is reviewed every 5 years, because adverse effects may appear and new molecules come to compete with it.<\/span>
\u2013 Patent expiry<\/span>
\u2013 Make way for generics: beyond 10 years, the patent expires and the product falls into the public domain.<\/span><\/p>\n

Top Selling Drugs<\/span><\/p>\n

By volume, analgesics are the best-selling drugs.\u00a0Next come drugs for the digestive or gastrointestinal tract.\u00a0<\/span>Then diabetes medication.<\/span><\/span><\/p>\n

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The Mediator affair or more recently the D\u00e9pakine affair are, among other things, the biggest health scandals of the decade in France.\u00a0The late withdrawal from the market of these long-contested drugs would be the cause of hundreds of deaths or major disabilities in France\u2026 How could this have happened?\u00a0How are drugs controlled? A drug only […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[297],"tags":[],"class_list":["post-4752","post","type-post","status-publish","format-standard","hentry","category-competition-consumer-law"],"yoast_head":"\nHealth scandals: how are drugs put on the market? - Soci\u00e9t\u00e9 d'avocats Damy<\/title>\n<meta name=\"description\" content=\"Medicine Regulation Un m\u00e9dicament n\u2019arrive sur le march\u00e9 qu\u2019apr\u00e8s un long processus d\u2019\u00e9laboration et de contr\u00f4le.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/gregorydamy.niceavocats.fr\/en\/medicine-regulation\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Health scandals: how are drugs put on the market? 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