I Sverige fick vi 1962 vår första moderna lagstiftning i och med läkemedelsförordningen. Den tillkom i skuggan av Neurosedynskandalen, men var i själva verket resultatet av ett utredningsarbete som pågått sedan början av 1950-talet med målet att få ett riksdagsbeslut under hösten 1962. Den innehöll inte några specifika regler för klinisk läkemedelsprövning. Sådana tillkom vartefter under en tioårsperiod. De handlade om klinisk prövning av oregistrerade läkemedel, vid nya indikationer och av läkemedel på människa utan samband med sjukdomsbehandling.
Det var väl helt enkelt så, att det inte fanns så många kliniska läkemedelsprövningar att reglera under 1960-talet. Men de skulle snart öka. Under 1980-talet gjordes runt tusen prövningar om året.
Under åren kring 1980 skärptes reglerna för läkemedelsprövning, först med ett förslag från Socialstyrelsen, sedan med riktlinjer antagna av Nordiska läkemedelsnämnden och till slut med en ny lagtext från 1982. Den följde Socialstyrelsens förslag med anpassning till de nordiska riktlinjerna.
Tio år senare var det dags för en ny översyn, delvis för att reducera mängden av förordningar och bestämmelser, delvis för att anpassa den svenska lagen till EG-rätten. Sverige hade då ansökt om medlemskap i EG och ämnade delta i EES-samarbetet.
Läkemedelslagen från 1992 kompletterades sedan med vissa tillägg från 2003 (Lagen om etikprövning av forskning som avser människor) och 2004 (viss EU-anpassning). Etikfrågorna rörde framför allt ”personer vars mening inte kan inhämtas på grund av sjukdom, psykisk störning, försvagat hälsotillstånd”. I sådana fall skulle samtycke inhämtas från god man (en långvarig procedur) och anhöriga.
Därmed fördröjdes eller försvårades prövningar på ”beslutsinkompetenta” vuxna. Och sådana försök hade Läkemedelsverket konsekvent stoppat sedan 2004.
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